Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Will Amazon "Crush" Pharma? DTC Marketers Should Prepare for the Inevitable

Will Amazon "Crush" Pharma? DTC Marketers Should Prepare for the Inevitable | Pharmaguy's Insights Into Drug Industry News |

Amazon's unrelenting drive to take over the world continues. The latest potential target of the online retailer's ambitions: prescription drugs.


According to reports, Amazon is exploring entering the retail pharmacy market in the U.S., a $400bn a year business that many believe is ripe for disruption. While a final decision has apparently not yet been made, it's not too early for pharma marketers to start considering the prospect of Amazon entering this huge market.


What it might mean for pharma marketers

The news of Amazon's interest in selling prescription drugs has, for obvious reasons, spooked investors in major pharmacy players like CVS, Walgreens and Express Scripts, all of which risk being disrupted by Amazon the way so many other businesses have.


For pharma marketers, Amazon's entry into this market could increase the importance of their direct-to-consumer marketing efforts… one of the best ways [pharma marketers] can prepare for the potential entry into the pharmacy market would be to evaluate their direct-to-consumer efforts in light of a changing landscape in which digital channels like social media increasingly trump established channels like television.


Amazon as frenemy?

While Amazon's entry into the retail pharmacy market could prove to be a net positive for pharma companies well-positioned to take advantage of it, there is also the potential that Amazon could become a frenemy.


How? As drug supply chain expert Stephen Buck, co-founder of Courage Health, pointed out, Amazon could eventually decide to manufacture its own generic medications. If that happened, pharma companies would find themselves competing with a company that also acts as, perhaps, one of their more important distribution channels.


This possibility too also demonstrates the importance of direct-to-consumer marketing, as pharma companies will want to do everything they can to establish the superiority of their drugs over generics that could one day be manufactured by Amazon.

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"No Generics for You!" No Biosimilars Either, Say Insurers!

"No Generics for You!" No Biosimilars Either, Say Insurers! | Pharmaguy's Insights Into Drug Industry News |

Consumers have grown accustomed to being told by insurers — and middlemen known as pharmacy benefit managers — that they must give up their brand-name drugs in favor of cheaper generics. But some are finding the opposite is true, as pharmaceutical companies squeeze the last profits from products that are facing cheaper generic competition.

Out of public view, corporations are cutting deals that give consumers little choice but to buy brand-name drugs — and sometimes pay more at the pharmacy counter than they would for generics.

The practice is not easy to track, and has been going on sporadically for years. But several clues suggest it is becoming more common.

In recent months, some insurers and benefit managers have insisted that patients forgo generics and buy brand-name drugs such as the cholesterol treatment Zetia, the stroke-prevention drug Aggrenox and the pain-relieving gel Voltaren, along with about a dozen others, according to memos and prescription drug claims that pharmacies shared with ProPublica and The New York Times. At the same time, consumers are sounding off on social media.

Now it appears the practice is spreading to biosimilars, the competitors for expensive, complex biologic drugs that are beginning to arrive on the market.

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The Top 15 Generic #Pharma Companies by 2016 Revenue

The Top 15 Generic #Pharma Companies by 2016 Revenue | Pharmaguy's Insights Into Drug Industry News |

Branded drugmakers weren't the only ones working through a tumultuous 2016. Generics companies faced pricing pressure, too. And while branded companies suffer pricing pain on costly cutting-edge therapies, generics outfits feel the pinch with already-thin margins, making pressure all the more agonizing.


How is the industry responding? By consolidating and hoping to save money, for one. …it's clear that some companies have made leaps too big to depend on organic growth alone.


Take Teva, which topped the 2016 list as it did in 2014. It wrapped up the biggest M&A move in recent history for the generics industry, swallowing Allergan’s unbranded offerings for $40.5 billion in August. The massive move will continue to reverberate in the generics industry for years to come.


Further Reading:

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Generic Drug Industry Trumps PhRMA’s PR By Re-Branding Itself. Should PhRMA Follow Its Lead?

Generic Drug Industry Trumps PhRMA’s PR By Re-Branding Itself. Should PhRMA Follow Its Lead? | Pharmaguy's Insights Into Drug Industry News |

The Generic Pharmaceutical Association is no more. Meet the Association for Accessible Medicines.


Every industry group invested in the drug-pricing debate is gearing up and burnishing its brand. PhRMA, the brand-name pharmaceuticals lobby, has its “Go Boldly” campaign (read “PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: Less Hoodies, More White Coats”; Now the generics lobby is launching its own “education campaign” under a whole new name.


“The Association’s new identity will improve recognition that the generic and biosimilar medicines industry is one of the nation’s great health care success stories, and that competition from generics and biosimilars lowers the cost of medicine,” Chip Davis, its president and CEO, said in a statement. “Our medicines drive savings, not costs, and we stand ready to work with the President, Congress, patient groups and others to create real and lasting health cost solutions.”


Generics figure to be major players in any resolutions that Congress or the Trump administration come up with for the drug-pricing debate. On the one hand, many lawmakers and groups, even PhRMA, talk about speeding generics to the market as a way to encourage competition and organically drive down prices. Some of the recent pricing controversies, such as Turing’s roughly 5,000 percent increase in the price of a life-saving drug, have centered on drugs that have long ago lost their patent protection, but never saw a generic competitor introduced.


But on the other hand, there are also incidences of extraordinary price increases for generic drugs. And some policy proposals make generic drug makers nervous, too. Senator Chuck Grassley’s bid to crack down on so-called pay-for-delay deals — litigation settlements between brand-name and generic drug makers that delay the introduction of a generic drug — are one item in particular that, according to people who work with generics, make those companies uneasy.

Pharma Guys insight:

It has been recommended that “Big #Pharma Should Secede From PhRMA” in order to differentiate itself from price gougers ( But maybe a name change would be better to wow & bamboozle the public.


What name should replace Pharmaceutical Research and Manufacturers of America? How about Association for Serious Science & Medicine (ASS&M)?

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Thank You Martin Shkreli for Goosing FDA to Act More Expeditiously to Approve Generics!

Thank You Martin Shkreli for Goosing FDA to Act More Expeditiously to Approve Generics! | Pharmaguy's Insights Into Drug Industry News |

In a significant move, the Food and Drug Administration late last week made a policy change that may prevent companies from pulling a Martin Shkreli.

The agency plans to expedite reviews of applications for generic drugs where only one treatment is currently sold. The shift was prompted by public outrage that erupted last fall when Turing Pharmaceuticals, which Shkreli ran before he was indicted for securities fraud, bought a life-saving drug called Daraprim and promptly jacked up the price by 5,000 percent, from $13.50 a tablet to $750.

“We identified a gap and were able to identify a path forward,” an FDA spokeswoman wrote us. “The change being made (allows the agency) to capture circumstances when the only approved product on the market is a generic drug.”

Even though Turing does not hold a patent on the medicine, used to treat a rare parasitic infection known as toxoplasmosis, the company was able to increase the price as it did because there was no generic competition. The drug maker runs a closed distribution system, and as a result, Turing has a monopoly on Daraprim. Even if a generic drug maker wanted to enter what was suddenly a more lucrative market, any company would encounter a delay winning FDA approval since the agency faces a huge backlog of applications.

“This is a big deal,” said John Rother, who heads the National Coalition on Healthcare, a collection of insurers, employers, and unions, among others, that have objected to rising prices. “This should provide a faster way to inject competition in the marketplace, so that the price gougers can’t get away with what they’re doing.”

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FDA Slow to Approve Generic Drugs - Helps Boost Drug Prices

FDA Slow to Approve Generic Drugs - Helps Boost Drug Prices | Pharmaguy's Insights Into Drug Industry News |

With anger soaring over high drug prices, 4,300 cheaper generic drugs are awaiting approval by the Food and Drug Administration.

The FDA acknowledges it has had problems in the past. Chronically underfunded, its generic drug office was long the poor stepchild of the agency. But the agency says it has made significant strides, in part because of measures known as the Generic Drug User Fee Amendments.

How much progress has been made since then depends on how you interpret the data.

The FDA acknowledges that drug applications completed in fiscal 2015 took an average of four years to review, and generic drug companies continue to complain about the lack of progress.

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Trade Agreement Helps Big Pharma Brands Block Generics & Biosimilars

Trade Agreement Helps Big Pharma Brands Block Generics & Biosimilars | Pharmaguy's Insights Into Drug Industry News |
US negotiators in Trans-Pacific Partnership (TPP) talks fought on behalf of big drug-making companies, championing intellectual property laws that would protect their profits from competition by generic medications, leaked documents have revealed.

Provisions in the draft text could make it extremely difficult for makers of generic drugs to compete with brand-name pharmaceuticals overseas, notes Politico. They would also block the sales inside the US of generic “biologics,” new and expensive treatments for dangerous maladies, thus restricting Americans’ treatment options.

Among the most controversial provisions in the draft document is the US insistence on “patent linkage,” which would bar governments of TPP member countries from approving generic drugs if there were any outstanding patent disputes. This would allow drug companies to quash competing generics simply by filing patent claims.

There’s very little distance between what Pharma wants and what the US is demanding,” Rohit Malpani, director of policy for Doctors Without Borders, told Politico.

Pharma Guys insight:

DeLauro, Slaughter, Schakowsky Statements on Leaked Intellectual Property Chapter of Trans-Pacific Partnership


NEW HAVEN, CT—Congresswomen Rosa DeLauro (D-CT), Louise Slaughter (D-NY) and Jan Schakowsky (D-IL) released the following statements today on the leaked Intellectual Property chapter of the Trans-Pacific Partnership:


“The leaked intellectual property chapter continues to reveal the concerns that we and our colleagues have raised over the substance of the Trans-Pacific Partnership,” DeLauro and Slaughter said. “People who have access to this agreement recognize that this is a massive corporate give away to Big Pharma. We have seen from other leaked sources that industry lobbyists have been directly involved with writing portions of the trade agreement. Despite claims by the Administration that the text may change significantly, the Republican majority just voted to give away Congress’s only source of leverage to improve the agreement by granting the Administration fast track authority.


“We should not sacrifice public health and access to affordable medicine at home and abroad in order to promote the financial interests of the world’s largest pharmaceuticals,” they continued. “The text proves that the Administration has essentially worked as a lobbying arm of Big Pharma, working to extend some of the patents and cripple the generic drug industry with unnecessary regulation. We will continue to demand that this agreement be released from the shadows into the light of day so that the American people can see what is being negotiated on their behalf, against their interest. We must defeat the TPP.”


Schakowsky said: “This leaked information confirms what we’d all feared: as currently drafted, the United States is pushing on TPP nations, over their objections, to agree to a provision that would benefit multinational corporations and big Pharma at the expense of health care consumers here in the United States and around the world.


“Rather than promoting the objections of big Pharma, we should be working to lower drug prices. We should not be crafting trade policies that raise the cost of life saving medications by them by blocking competition from generic drugs. Enough is enough – our negotiation position leads to responsible trade policies that put lives ahead of corporate profits.”

CAROL ISELIN's curator insight, December 5, 2015 3:06 PM

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Generic Drugs Shows A Four-to-One Lead Over Branded

Generic Drugs Shows A Four-to-One Lead Over Branded | Pharmaguy's Insights Into Drug Industry News |

A new Harris Poll finds Americans favor generic prescription drugs over brand name products by a considerable margin. Eighty-one percent of those who buy prescription drugs say they would purchase generics more often than brand name drugs. A 42% subset goes so far as to assert that they would “always” choose to buy a generic drug. Older generations are especially likely to indicate that they would always go with generics (50% Matures, 44% Baby Boomers, and 46% Gen X vs. 33% Millennials).

Only 19% of those who purchase prescription drugs would more often choose to fill their script with the brand name drug, and a mere 6% would “always” choose brand names. It is worth noting, however, that though majorities of adults both with and without children in their households favor generics, the minority preference for brand names is stronger among those with children in the household (24% with vs. 17% without).

Though an admittedly low percentage of generic drug buyers are unwilling to pay any out-of-pocket costs, the percentage has doubled in the past six years, from 4% in 2008 to 8% now. Meanwhile, half (50%) of those who would buy generic drugs say they would be willing to pay 10 dollars or less for a 30-day supply, 28% would pay between $10.01 and $25, and 11% would be open to out-of-pocket expenses between $25.01 and $50. Only 4% would shell out over 50 dollars to get their prescription filled with a generic.

Pharma Guys insight:

According to a Reuters article, "Leading global pharmaceutical companies have started to view their vast portfolios of older, established prescription drugs as vehicles for raising large sums of cash to fuel development of new medicines with far higher profit margins" (see "Big Pharma stands to profit by cleaning out its medicine chests").

This means that many millions of patients who take “older” drugs may be left without the kind of “beyond-the-pill” support big pharma has been hyping up recently.

Instead, they will have to depend on branded generics whose formulations may differ from the original forms and may be dangerous -- an argument big pharma often makes against generic medications. And generic manufacturers are even less likely than brand companies to offer patient support and services.

Also, generic drug prices are increasing as demand rises. For more on that read "The End is Nigh! Judgment Day For Low Cost Generic Meds."

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Supreme Court Helps Teva Keep MS Patients Paying for Branded Drug Until 2030

Supreme Court Helps Teva Keep MS Patients Paying for Branded Drug Until 2030 | Pharmaguy's Insights Into Drug Industry News |

Teva Pharmaceuticals received a boost today from the U.S. Supreme Court, which overturned a decision by a federal appeals court that had invalidated a key patent on its Copaxone multiple sclerosis drug.

For Teva, the ruling provides valuable time to shift patients to a longer-action version of Copaxone with patent protection until 2030. The drug maker hopes to shift up to 80% of existing patients to the newer version before generics arrive and, so far, conversion is going well so far, according to BMO Capital Markets analyst David Maris. He notes that about 63% of total existing patients and 51% of new patients have been switched.

Of course, generic drug makers could risk launching copycat versions before the litigation ends, but Barclays analyst Doug Tsao thinks is unlikely.

“Until now, pending the Supreme Court decision, the patent had been invalidated, so even though generics would have been launching at risk, they would not have been subject to treble damages” if they were to sell copycat versions but then lose the patent litigation, he writes in an investor note.

“In our view, the threat of treble damages, as well as the low likelihood of winning on appeal now makes it appear considerably less likely that generic challenges would launch at risk, even if they received FDA approval before a final court decision.”

Pharma Guys insight:

It's unclear how Teva is "switching" patients to the new version of its Alzheimer's drug Copaxone. Recall the Actavis is pioneering "product hopping" in its bid to switch patients to NamendaXR. This is a "forced switch" because Actavis actually removed the older version from the market (see here).  That also is in litigation where a federal judge overturned a lower court's decision. In the Teva case,  Justice Stephen Breyer in the majority opinion said that “A district court judge who has presided over, and listened to, the entirety of a proceeding has a comparatively greater opportunity to gain that familiarity than an appeals court judge who must read a written transcript or perhaps just those portions to which the parties have referred.” Presumably, the same would be true in the Actavis case.

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New Generic Drugs are Pushing Older, Cheaper Ones Out of the Market

New Generic Drugs are Pushing Older, Cheaper Ones Out of the Market | Pharmaguy's Insights Into Drug Industry News |

For decades, generic prescription drugs have been considered the bargains of the pharmaceutical world. An industry group says Americans have saved more than $1.5 trillion in the past 10 years on brand name drugs, thanks to generics. But in recent months, prices on some of the most popular drugs have soared, and experts are trying to figure out why. 

The popular antibiotic doxycycline is used to treat common problems like urinary tract infections and pneumonia. It cost a mere $20 for a 500 pill supply in October 2013. Yet this past April, its price had hitmore than $1,800. Don’t do the math on the percentage increase, it could get ugly.

By the way, doxycycline has been on the market for 40 plus years, and the formula hasn’t changed.  So what’s going on here?

Drugs have "life cycles"

"These recent drug shortage and price hikes illustrate a third stage of the life cycle of a drug that we haven't really paid much attention to yet," says Jeremy Greene, a Johns Hopkins professor and author of Generics: the Unbranding of Modern Medicine.

"What happens when a drug is no longer particularly attractive to generic manufacturers? Or when the interests of the generic marketplace continue to go towards the second pipeline, the pipeline of drugs that are going off patent now and the drugs that have been off for patents for a while are no longer particularly attractive and get neglected," he says.

Pharma Guys insight:

Could the branded pharma companies have something to do with this? Their marketers have often implied that "newer is better" when their drugs were "me-too" products that did not offer much more than older branded drugs. When those drugs go off patent, physicians still remember the "newer is better? mantra and opt for the newer generics. Just trying to make some sense out of this to see if marketing has a role here.

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FDA to Study Effect of Generic Pill Size & Color on Adherence

FDA to Study Effect of Generic Pill Size & Color on Adherence | Pharmaguy's Insights Into Drug Industry News |

Generic drugs make up approximately 85 percent of all human prescription drugs prescribed in the United States. While generic drugs are required to be pharmaceutically equivalent and bioequivalent to their brand-name counterparts, generics made by different manufacturers may differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance (e.g., color, shape, or size of pills). When pharmacists switch generic drug suppliers, patients refilling their generic prescriptions may therefore experience changes in their drugs' appearances. These changes may result in patient confusion and concerns about the safety and effectiveness of the generic drug products. Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs' physical appearances, leading to harmful clinical and public health consequences as well as increased health care costs from avoidable morbidity and mortality.

To provide additional information that may help guide regulatory policy or pharmacy business practices, we intend to conduct surveys of pharmacists and patients about their perceptions about and experiences with generic drugproduct pill appearance change. These surveys are intended to further our understanding of the relationship between changes in pill appearance and non-adherence to prescribed therapeutic regimens. The surveys may enable us to investigate factors that may explain the association between changes in pill appearance and non-adherence, including which factors could be modified to improve the safe and effective use of generic drugs.

We intend to survey a national cohort of pharmacists about their experiences with dispensing generic drug pills that differ in appearance from previous refills of the same medication and dosage level (e.g., when pharmacies switch generic suppliers).

Pharma Guys insight:

The Generic Pharmaceutical Association (GPhA), in comments to FDA (here), reminds the agency that "there is no provision in Hatch Waxman allowing FDA to deny approval of an ANDA based on differences in physical attributes between a generic product and the listed drug it references. The premise of the Draft Guidance, that generic drugs must mimic the reference listed drug in size and shape, has no basis in law. In our view, an FDA action related to the physical characteristics of generic drugs must be tied to the safety of those drugs to avoid exceeding FDA's statutory mandate." 

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New Study Finds Programs Designed to Protect Safety Being Widely Abused, Delaying Generic Choices for Consumers

New Study Finds Programs Designed to Protect Safety Being Widely Abused, Delaying Generic Choices for Consumers | Pharmaguy's Insights Into Drug Industry News |

The ongoing abuse of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending that could be saved if 40 drugs examined in a Matrix Global Advisors report released today were allowed to come to market. The study, commissioned by the Generic Pharmaceutical Association, also found that after biosimilars enter the market, misuse of Risk Evaluation and Mitigation Strategies (REMS) and other restricted access programs would result in approximately $140 million in lost savings for every $1 billion in biologics sales.

“For patients waiting for generic alternatives to expensive brand medicines, every day counts. For lawmakers struggling to balance the budget, every dollar matters,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA). “This study shows that by using safety programs as a smokescreen for anti-competitive practices, some brand companies are delaying generic choices for patients and driving up drug costs.

Further, allowing these kinds of abuses to continue unabated threatens the cost savings potential around the next frontier of innovation: biosimilars. The data reveals that allowing these practices to go unchecked will have exorbitant and spiraling costs. These critical medicines have increasingly become the standard of care for many serious conditions, accounting for $92 billion of U.S. drug spending in 2013. This could mean tens of billions more in lost savings in the future.”

The study, titled Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry, examines the practice of abusing REMS and “Restricted Access Drug” programs to deny generic drug firms access to samples of brand drug products. Without access to these samples, which traditionally have been purchased by generic drug applicants through wholesalers, manufacturers cannot conduct appropriate testing and secure subsequent approval of generic medicines. Refusing access to samples effectively delays generic alternatives for patients, and extends brand product monopolies. The study was based on 40 products identified in a confidential survey of eight generic manufacturers and conducted from December 2013 to March 2014.

“This report is the first clear picture of the costs imposed by misuse of REMS and other restricted access programs,” said Alex Brill, CEO of Matrix Global Advisors. “By finding ways to obstruct the generic approval process, brand companies protect their market share and keep generics off the market. Our research also reveals that the practice clearly extends beyond traditional REMS programs. In more than 20 cases, manufacturers reported brand companies using non-REMS restrictions to block access.”

The key findings of the study include:

• REMS programs are widespread.
o FDA requires REMS programs for almost 40 percent of new drug approvals, according to briefs presented in litigation on this issue.
• Brand manufacturers have also begun imposing distribution restrictions on non-REMS products.
o Manufacturers report that brand drug companies have used non-REMS restrictions to block access to more than 20 products.
• These abuses cost the government, patients, and the health system billions of dollars.
o Annually, $5.4 billion in savings is lost from 40 generic small-molecule products whose market entry is currently delayed as a result of misuse of REMS and other restricted access programs.
o The federal government bears a third of this burden, or $1.8 billion.
o Private insurance companies lose $2.4 billion.
o Consumers pay $960 million in extra out-of-pocket costs.
o State and local governments, and other small payors, lose savings of $240 million.
• If it continues, this issue also can be expected to have a major negative impact on savings from biosimilars once the FDA provides final guidance for biosimilars.
o Delaying biosimilar entry by restricting access to samples would result in approximately $140 million in lost savings for every $1 billion in biologics sales.

Pharma Guys insight:

Read the full report:
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry , Matrix Global Advisors, July 2014.

Key findings and issue overview

H. Fai Poon's curator insight, July 24, 2014 7:55 PM

This is just wroung

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Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics

Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics | Pharmaguy's Insights Into Drug Industry News |

In an unprecedented move, leading global pharmaceutical company Allergan appears to have handed its Orange Book-listed US patents covering its blockbuster dry eye drug Restasis to the Native American St. Regis Mohawk Tribe in Northern New York.  

The Tribe has granted exclusive licenses in the patents back to Allergan.  The deal will provide the Tribe, which has a population of around 13,000, with $13.75 million up-front and annual royalties of up to $15 million, (crucially, in this case) provided the patents remain valid.

Allergan may have made the move in an attempt to evade challenges from competitors at the Patent Trial and Appeal Board (PTAB) – an administrative court created in 2011 that can cancel patents – in a somewhat controversial, post-issuance review process called "inter partes review" (IPR).

IPRs against the Allergan patents were launched on behalf of generics companies Mylan, Teva, and Akorn Pharmaceuticals. They were expected to reach a result this December. 

Although the deal creates what may seem like a significant yearly dent in Allergan’s accounts, annual sales of Restasis stand at approximately $1.5 billion – second only to Allergan’s biggest-selling, wrinkle treatment product, Botox – and are expected to increase.  With the patents covering Restasis not due to expire until 2024, this multi-million dollar outlay in exchange for extra protection could turn out to be a shrewd piece of business by Allergan’s decision makers.

IPRs were authorised by the 2011 America Invents Act and have arguably revolutionised the way and regularity in which patents are challenged in the USA.  While invalidating a patent via litigation in federal court typically costs millions of dollars, invalidating a patent through the IPR process costs the challenger the relative bargain of a few hundred thousand dollars.  This is similar to the European post-grant opposition process.

The Tribe is, in theory, able to file a motion to dismiss the ongoing IPRs against the granted Restasis patents on account of its “sovereign immunity” status. 

IPRs were designed to improve the US patent system, and quickly and efficiently settle patent validity disputes on novelty and obviousness.  Statistics have shown that fewer IPR petitions are brought against biotech and pharma patents, and there is a lower rate of invalidation of these compared to all technical fields combined, but Allergan have seemingly gone on the defensive early doors. 

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A Chance for Pharma Sales Reps to “Cleanse” Their Souls: Work for Insurers to Promote Generics to Docs

A Chance for Pharma Sales Reps to “Cleanse” Their Souls: Work for Insurers to Promote Generics to Docs | Pharmaguy's Insights Into Drug Industry News |

As a drug salesman, Mike Courtney worked hard to make health care expensive. He wined and dined doctors, golfed with them and bought lunch for their entire staffs — all to promote pills often costing thousands of dollars a year.


He’s on a different mission now: When he calls on doctors, he champions generic drugs that frequently cost pennies and work just as well as the kinds of expensive brands he used to push.


Instead of Big Pharma, he works for Capital District Physicians’ Health Plan, an Albany, N.Y., insurer. Instead of maximizing pill profits, his job is to save millions of dollars by educating doctors about expensive prescription drugs and the stratagems used to sell them.


“Having come from Big Pharma, I do really feel my soul has been cleansed,” Courtney said with a laugh. He formerly worked for Pfizer and Johnson & Johnson. “I do feel like I’m more in touch with the physicians” and plan members, he added.


Two years ago, when one company increased the cost of a common diabetes medicine to 20 times what it had been a few years earlier, Courtney and five other former pharma and medical-device representatives working for C.D.P.H.P. knew what to do.


Valeant Pharmaceuticals had cranked up the price of a common dosage of Glumetza, a medicine for lowering blood sugar, to an astonishing $81,270 a year, according to Truven Health Analytics, a data firm. Meanwhile a similar generic version could be bought for as little as a penny a pill.


After Courtney and his colleagues alerted doctors to Valeant’s practices, all but a handful of the 60 plan members who were taking Glumetza switched to metformin, the generic alternative. That saved about $5 million in a year.


The idea to hire Big Pharma representatives originated with John Bennett, a cardiologist, a few years ago, after he became C.D.P.H.P.’s chief executive. He knew that the sales representatives were smart, genial and motivated. Overhiring by the pharmaceutical companies had put many back in the job market.


His sales pitch to them, he says half-jokingly, was: “You know everything they taught you in Big Pharma? How would you like to use those powers for good?”

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The Top 10 U.S. Drug Patent Losses for 2017

The Top 10 U.S. Drug Patent Losses for 2017 | Pharmaguy's Insights Into Drug Industry News |

Among the many meds that’ll lose patent protection in the U.S. this year are 10 drugs that each contribute in a big way for top drugmakers. Eli Lilly, Pfizer, Takeda, Bristol-Myers Squibb and Gilead are each set to hit the patent cliff this year with some of their respective big sellers.


Together, they brought in more than $10 billion last year in the U.S. and cover a range of indications: multiple sclerosis, HIV, erectile dysfunction and cancer, among others. They’ll be hot targets as generic rivals rush to steal share with cheaper options.


Just when a drug will lose market exclusivity isn’t always clear, with add-on patents and legal settlements occasionally clouding the picture. We've focused not only on drugs that will lose their patent shields in 2017, but those that, because of patent litigation or settlements, will find themselves vulnerable to generic or biosimilar competition.

Via Richard Meyer
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Off-patent Drugs at Brand-Name Prices: A Puzzle for Policymakers

Off-patent Drugs at Brand-Name Prices: A Puzzle for Policymakers | Pharmaguy's Insights Into Drug Industry News |

In August 2015, Turing Pharmaceuticals acquired the marketing rights to Daraprim (pyrimethamine), a drug used to treat parasitic infections like malaria and toxoplasmosis. Soon after, Turing caused an uproar when it announced that it would raise the price per tablet of Daraprim from $13.50 to $750$13.50 to $750, a 5500% price hike for a drug that has been on the market for over 60 years and off patent since the 1970s. Old, off-patent drugs are becoming increasingly expensive; Daraprim is the archetypal example. Turing had the power to set a high price for Daraprim because the drug's limited patient population, the absence of competing manufacturers, and a lack of therapeutic alternatives all created an effective monopoly. Similar forces have driven up the prices of other off-patent drugs that treat diseases as diverse as heart failure and multi-drug-resistant tuberculosis. Thus, policymakers will have to consider how the high cost of off-patent drugs impacts public health as well as public spending. In this Note I outline the extent of the high-cost off-patent drug problem, drawing special attention to the problem's negative effects on both health outcomes and government budgets. After discussing some of the problem's underlying causes, I present several solutions to the problem that policymakers could consider, with a focus on proposals like reference pricing and expanded compounding that have received relatively little media attention.

Pharma Guys insight:

Related articles: The End is Nigh! Judgment Day For Low Cost Generic Meds; Generic Drugs Kept Health Care Cheaper for 30 Years. Why Are Their Prices Surging?;

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A Few Major #Pharma Drugs Will Lose Patent Protection in 2016

A Few Major #Pharma Drugs Will Lose Patent Protection in 2016 | Pharmaguy's Insights Into Drug Industry News |
When a pharmaceutical company develops and “brands” a drug, it's held under patent protection. Here are the patents expiring in 2016.

2016 is going to be a big year. We’ll elect a new president, see our best athletes head to the summer Olympics in Rio de Janeiro and celebrate a leap year. However, 2016 is also a year to watch in the pharmaceutical industry. Several highly profitable drugs are going off-patent in 2016, losing the protection of the company that has held all rights to the drug – and ensuring that it won’t be long until cheaper generic alternatives hit the shelves.

Pharma Guys insight:

Doesn't mean there will soon be generic versions available. See "

FDA Slow to Approve Generic Drugs - Helps Boost Drug Prices"; 

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Turing Test: Will Market Pay High Prices for Generic Drugs?

Turing Test: Will Market Pay High Prices for Generic Drugs? | Pharmaguy's Insights Into Drug Industry News |
Given that Big Pharma executives are mostly visible monsters with fangs and horns, they usually avoid the spotlight. But after raising the cost of a life-saving pill by 5,000 percent, Turing CEO Martin Shkreli is loudly telling the world to fuck off.

Only a bad guy from Captain Planet could come up with a more brazenly amoral business scheme: Turing Pharmaceuticals purchased the rights to Daraprim, a 62-year-old drug used to treat toxoplasmosis, a parasitic affliction that affects tens of millions in the U.S. alone. Daraprim is particularly important for AIDS and cancer patients, whose weakened immune systems are ravaged by toxoplasmosis. Shkreli has now directly, intentionally switched the drug from affordable to insanely out of reach, Healio reports:

Since its acquisition, the price of pyrimethamine has increased from $13.50 per tablet to $750 per tablet, according to IDSA and HIVMA. In an open letter to Turing, the organizations urged the pharmaceutical company to revise its pricing strategy for the generic medication.

“Under the current pricing structure, it is estimated that the annual cost of treatment for toxoplasmosis, for the pyrimethamine component alone, will be $336,000 for patients who weigh less than 60 kg and $634,500 for patients who weigh more than 60 kg,” they wrote. “This cost is unjustifiable for the medically vulnerable patient population in need of this medication and unsustainable for the health care system.”

Shkreli isn’t just a regular, run-of-the-mill pharmaceutical industry monster. He’s a monster who used to work (of course) in finance, a former hedge funderaccused of having tried to manipulate FDA regulations on drug companies whose stocks he was shorting. He was forced out of the last drug company he started, which is now suing him for $65 million. He’s also a probable charlatan who has claimed to have invented his own pharmaceuticals, despite his lack of any medical or scientific education.

(Shkreli is able to do price-gouge a generic drug by exploiting a few FDA loopholes that give companies exclusive licensing rights to certain older drugs, and allow them to deny other companies the access to those drugs needed to prove that a generic alternative is chemically identical.)

Pharma Guys insight:

This isn't the first case of price-gouging generic drugs. Read, for example, "Branded Pharma Wages War Against Generic and OTC Medicines: COLCRYS vs. colchicine Case Study": 

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The Case of Brand Colcrys vs. Generic colchicine: Santa Claus (i.e., consumers) Pays the Price

The Case of Brand Colcrys vs. Generic colchicine: Santa Claus (i.e., consumers) Pays the Price | Pharmaguy's Insights Into Drug Industry News |

Six years ago, the FDA approved a drug called Colcrys to treat acute gout attacks and familial Mediterranean fever, an inherited inflammatory disorder. The move came as part of an agency initiative to regulate dozens of medicines that had never been formally approved, but were on the market when the FDA received authority to oversee the drug approval process.

In this instance, Colcrys was the brand name given colchicine, which was sold for decades by several companies and cost 9 cents a pill. URL Pharma won FDA approval – and seven years of marketing exclusivity – by running a small study that gauged the effectiveness of different dosages. URL sued other colchicine makers and, by early 2011, marketing exclusivity took hold. And Colcrys cost $5 a pill.

Now, a new study says the approval was not worth the effort, at least for patients. Harvard Medical School researchers examined nearly 217,000 enrollees in an insurance database who were diagnosed with gout or FMF before and after marketing exclusivity kicked in. Here is what they found:

The likelihood of receiving a prescription for either colchicine or Colcrys to treat either malady dropped during the year after the marketing exclusivity took hold – 0.5% per month for gout sufferers and 7.6% for patients with FMF. Meanwhile, prescription costs and related health care costs for gout and FMF patients rose during the same period, by 55% and 38%, respectively, according to the study.

“This shows that this type of incentive can go wrong,” says Aaron Kesselheim, a study co-author and an associate professor of medicine at Harvard Medical School. “The market exclusivity was granted for behavior that didn’t provide much public health benefit. But it caused the price to go up, increased spending by patients and reduced use of the drug, which has potentially bad public health implications.”

The findings follow substantial criticism that was leveled at the FDA not long after the approval led to the price hike, since Colcrys was not a new drug.

Pharma Guys insight:

This just confirms what I wrote about back in July, 2011, in a blog post:

"URL Pharma's War against "generic" colchicine was recently in the news when it was discovered that its attorneys sent threatening letters to doctors who were prescribing "generic" colchicine. Some doctors had advocated use of a cheaper version of the drug, whose active ingredient is colchicine. In response, URL Pharma's general counsel sent letters to several of the critics asking them to "clarify the record" and saying there were "potential risks and liability" associated with using unapproved versions (see "Pharma Company Sends Letters to Docs Who Criticized Drug Online").

Not only doctors are complaining about this, so are patients. I recently received this letter from a reader:

"This colchicine thing is just the beginning of wiping out low price and low profit generic drugs. Preparation H could be next!

"How is it that – as you can see from my CVS receipt in January, the cost for 60 colchicine pills (one month’s supply) was $27.80 - $8 paid by me and $19.80 paid by my Part D Medicare insurance. This has been the cost ballpark for the 10 years or so that I have been taking colchicine. (My copay under Part D is 20%, so I should have paid $5.56, but I have an $8.00 minimum copay).

"But then something happened, and all of a sudden, colchicine became a “new” super drug, even though it’s been around since the days of the Roman Empire. It is now called Colcrys, and you can see from my May receipt that my 20% copayment under Part D was $51.43, meaning that the full price is now $257.15."

For more on that, see here: 

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Here's a Good Example of Why #Pharma's Rep is So F**ked Up. But That's Free Enterprise, i.e., Capitalism!

Here's a Good Example of Why #Pharma's Rep is So F**ked Up. But That's Free Enterprise, i.e., Capitalism! | Pharmaguy's Insights Into Drug Industry News |
Price surges for naloxone could deter efforts to curb heroin overdoses.

The ongoing fight over Big Pharma’s pricing policies continues as congressional leaders shift their focus to a drug that police departments use to treat heroin overdoses. While law enforcement agencies have become more accepting of this approach to combat drug abuse, recent price spikes put the future of city and state distribution programs in jeopardy.

Earlier this week, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) blasted Amphaster Pharmaceuticals, the maker of the drug naloxone, in a letter in which the duo questioned the rationale of increasing the price of the drug during a time when heroin overdose deaths have more than tripled within a three-year period.

“Over the past several months, police departments, law enforcement agencies, and public health officials across the country have warned about the increasing price of naloxone, which they use to combat the scourge of heroin abuse,” Sanders and Cummings wrote in their letter.

Naloxone, a generic drug that’s also known as Narcan, reverses the effects of potentially fatal opioid overdoses by relieving the depression of the nervous and respiratory systems and quelling symptoms of hypertension. Nearly half of U.S. states have passed laws granting wider access to naloxone, which can be administered in the bloodstream and through the nostrils. Doctors in those states can prescribe naloxone to friends and family members of opioid abusers. These measures also remove liability from people who dole out the drug, including police officers.

In April 2014, the Food and Drug Administration approved Evzio, a user-friendly naloxone injector to the satisfaction of public health officials and advocates. However, a sticker price of more than $400 keeps the tool out of the hands of many people who would prefer having the drug on hand in case a friend or family member overdoses. The price of the formula that can be injected nasally also doubled to the chagrin of law enforcement officials and heads of nonprofits, many of whom have turned to Amphaster — its sole producer — for answers.

“You’re being held at the whim of companies that can do what they want because they have a monopoly on a drug,” Eliza Wheeler, project manager for the Harm Reduction Coalition’s DOPE Program, told MedPage Today in November 2014. “The balance of our program rests on whether we can afford a product. That they can wantonly raise the price is terrifying.”

Pharma Guys insight:

This year, police departments across the country, including in New York City, announced plans to stock up on a medication that reverses the effects of a heroin or opioid painkiller overdose.

The move signaled a shifting approach for officers more accustomed to fighting drug abuse with arrests than with a medical antidote.

But police and public health officials from New York to San Francisco are facing sticker shock: Prices for a popular form of the medication, naloxone, are spiking, in some cases by 50 percent or more.

What's going on is a spike across the board in generic dug prices. 

Historically costing pennies on the dollar compared with a brand-name drug, generic drugs have long been considered a vital weapon in the fight to contain soaring health-care costs. But in the past year, the price of many generics has disconcertingly moved in the wrong direction, drawing the attention of Congress and pinching the wallets of consumers as well as pharmacies and insurers.

“We are talking about the need of the American people to be able to afford the medicine that their doctors prescribe,” Sen. Bernie Sanders, I-Vt., chairman of a Senate health-care subcommittee, said at a hearing on the issue late last week. “There appears to be now a trend in the industry where a number of drugs are going up at extraordinary rates. We wanted to know if there was a rational economic reason as to why patients saw these price increases or whether it was simply a question of greed.”

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Pfizer's Weird Patent Game: Threaten Doctors Who Prescribe Lyrica (pregabalin) Off-Label

Pfizer's Weird Patent Game: Threaten Doctors Who Prescribe Lyrica (pregabalin) Off-Label | Pharmaguy's Insights Into Drug Industry News |

Trying to force people to avoid generic competition is increasingly widespread. [Here's a] disturbing, story about Pfizer directly threatening doctors should they decide to prescribe generic versions of pregabalin, an anti-epilepsy drug, that will go off patent in 2015. But here's the tricky part: Pfizer holds a different patent on the same drug if it's used to treat pain (rather than epilepsy). Pfizer is claiming that prescribing the generic version for pain use would lead to serious problems -- even though it's the same damn drug.

You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy. 

As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called "skinny labels" and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain. 

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.

As Cory Doctorow notes in the article above, Pfizer here seems to be trying to take its own "stupid problem" and make it everyone else's stupid problem:

Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem. The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'. Doctors' duty is to science and health, not Pfizer's profit-margins. Scientifically, there's no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals. 

If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.

Pharma Guys insight:

Meanwhile, I have noticed an up tic in Lyrica DTC advertising on TV. Five drugs on the 2013 Top 20 DTC spending list - Viagra, Celebrex, Lyrica, Xeljanz, and Chantix - are marketed by Pfizer. For more on that, read The Top 20 DTC Ad Spenders in 2013 Virtually Ignored Digital

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Generic Drugs Kept Health Care Cheaper for 30 Years. Why Are Their Prices Surging?

Generic Drugs Kept Health Care Cheaper for 30 Years. Why Are Their Prices Surging? | Pharmaguy's Insights Into Drug Industry News |

Earlier this fall, a gathering of Washington politicians and wonks celebrated the birthday of a piece of paper: the Price Competition and Patent Extension Act of 1984, also known as the Hatch–Waxman Act. 

When the bill was signed into law 30 years ago, it streamlined the approval process for bioequivalent generic drugs as soon as the patent expired on the original medication. The subsequent expansion of the generic drug market, from less than 3 out of 10 prescriptions in 1984 to more than 8 out of 10 by 2014, is one of the few success stories among the United States’ many failed efforts to provide high-quality health care at a lower price. Total U.S. pharmaceutical expenditures actually dropped in 2012, and the Generic Pharmaceutical Industry Association estimates that generic drugs saved the American health system nearly $1.5 trillion dollars from 2004–2013.

Beginning this week, however, Washington will host a very different conversation about generic drugs, as independent Vermont Sen. Bernie Sanders (chairman of the Subcommittee on Primary Health and Aging) and Maryland Rep. Elijah Cummings (the ranking Democratic member of the Committee on Oversight and Government Reform) open a set of hearings into the rapid increase in generic drug prices in recent years. Drugs previously available at pennies per pill now cost hundreds of dollars per bottle. And not just esoteric, small-market drugs, either: the antibiotic doxycycline, a workhorse drug for common infections from sinusitis to pneumonia, cost $20 per 500-count bottle last October. Last month, the average price for the same supply was $1,849. For a drug initially approved by the FDA in 1967, the price hike seems mystifying.

What explains the sudden spike in generic drug prices?

Pharma Guys insight:

I've heard that the price of generics has NEVER been as low as some people believe even in times where there were no shortages. Actually, the prices of some generics can be as much as 80% of the equivalent brand name drug. Why is that? I mean generic drug companies have practically NO marketing budgets, which have been blamed for high brand name drug prices by pharma critics. You'd think that without the marketing and associated overhead expenses, generic drugs would be dirt cheap!

The fact is, "three-quarters of prescriptions these days are filled with a generic," points out NPR. "And the proportion keeps climbing." That means that generic drug companies have almost "cornered the market" (for small molecule drugs) and can charge what that market will bear (in the U.S., that is, where there are no price controls).

For more on this, read The End is Nigh! Judgment Day For Low Cost Generic Meds.

What about insurers gouging the public?

Insurers have long tried to steer their members away from more expensive brand name drugs, labeling them as "non-preferred" and charging higher co-payments. But according to an editorial  in the American Journal of Managed Care, several prominent health plans have taken it a step further, applying that same concept even to generic drugs.

The Affordable Care Act bans insurance companies from discriminating against patients with health problems, but that hasn't stopped them from seeking new and creative ways to shift costs to consumers. In the process, the plans effectively may be rendering a variety of ailments "non-preferred," according to the editorial.

For more on this, read A New Way Insurers are Shifting Costs to the Sick.

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One Drug. Two Prices. A Reporter Struggles to Find Out the Cost of His Son’s Prescription

One Drug. Two Prices. A Reporter Struggles to Find Out the Cost of His Son’s Prescription | Pharmaguy's Insights Into Drug Industry News |
$15 or $30? Health reporter Charles Ornstein is charged two different prices for the same drug. Which one is right? His effort to find out illustrates consumer frustrations with the health care system.

Consumers are navigating a health care system in which they pay an increasing share of the cost but often have insufficient information to make the right decisions. They assume that pharmacies are charging them the right co-payments, that insurance companies are paying the correct share. But as health plans' rules for prescription drugs become more complicated, it's harder to tell.

It used to be that generic drugs had one common co-pay and name-brand drugs another. But that's not always the case anymore, as with my plan. Some generic drugs are expensive, and consumers sometimes pay a higher share of their cost, more akin to what they would pay for a name brand.

Pharma Guys insight:

Back in May, 2011, I predicted the coming of "Judgment Day For Low Cost Generic Meds:"

Several recent signs suggest that the stars are aligned against low cost generic drugs. Here's my summary of these signs.

For quite some time we've heard about "Big Pharma’s Record Drug Shortages" (see "The nation is facing an unprecedented drug shortage" and "What’s Behind Big Pharma’s Record Drug Shortages?"). Shortages might be caused by "too many mergers and acquisitions" that have reduced the number of suppliers.

Those stories put the blame on "Big Pharma," by which they mean brand name drug manufacturers. However, lost in the copy is the FACT that "almost all the shortages are generic drugs."

The second sign was reported by Jim Edwards over at bnet in his post "4 Pharma CEOs Admit They Jack Up Drug Prices for the Hell of It." 

Edwards quotes David Snow, chief executive officer at Medco Health Solutions: “As their branded drugs approach the patent cliff, there has always been the tendency to see increased pricing toward the end, just to get the last dollar out of every drug before they lose brand protection."

Yet an NPR article titled "Big Pharma's Golden Age Leads To Generics Windfall" suggests the "wave" of drugs going generic "can save consumers plenty of dough."

That would be true if generic drug companies as well as brand drug companies were not jacking up prices "for the hell of it." Actually, prices are jacked up because there is a shortage, which can be artificially produced if there is a drug industry consolidation, which there seems to be in both the generic and brand name industries.

I've heard that the price of generics has NEVER been as low as some people believe even in times where there were no shortages. Actually, the prices of some generics can be as much as 80% of the equivalent brand name drug. Why is that? I mean generic drug companies have practically NO marketing budgets, which have been blamed for high brand name drug prices by pharma critics. You'd think that without the marketing and associated overhead expenses, generic drugs would be dirt cheap!

The fact is, "three-quarters of prescriptions these days are filled with a generic," points out NPR. "And the proportion keeps climbing." That means that generic drug companies have almost "cornered the market" (for small molecule drugs) and can charge what that market will bear (in the U.S., that is, where there are no price controls). 

And soon the generic drug industry will "corner" the biologic drug market as well.

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