Some off-patent drugs have so few side effects that they are now available without a prescription.
The drug is off-patent, but Novartis, which makes it, has said it disagrees with the findings.
Prozac is now off-patent and is not a significant source of revenue for the drugmaker.
Since antianxiety medicine BuSpar went off-patent in April, for instance, sales of the drug have dropped 54%.
First, some medicines could have most of their sales in the U.S. because they are off-patent elsewhere.
It was expected that combining Zetia and Zocor, an off-patent statin, would do this better than Zocor alone.
But other off-patent drugs are doing less well without intellectual property law's protection.
Its top seller, heartburn treatment Nexium, is often criticized for being little different from the off-patent pill it replaced.
Cipla, a manufacturer of off-patent drugs in India, says that it plans to supply the drug cheaply next year.
These are cheaper and more sustainable options for governments in low-income countries for the basic, off-patent medicines that are needed.
Lyrica, an improved version of the off-patent Neurontin, was initially delayed for several years at the U.S. Food and Drug Administration.
Merck and Schering already sell a medicine, Vytorin, that combines Zetia with Merck's off-patent cholesterol medicine Zocor, once Lipitor's main rival.
But it doesn't make the London-based drug giant much money anymore: Tamoxifen went off-patent and is now available as a cheap generic.
Under existing regulations, generic firms can compete against an off-patent branded drug and battle for first-to-file, 180-day exclusivity to market a generic replacement.
There are no more big drugs going off-patent through the end of the decade, he wrote, and new medicines more than support the company's valuation.
The drug is off-patent, but Novartis (nyse: NVS - news - people ), which makes it, has said it disagrees with the findings.
Drugs that falter in development, or come off-patent, are less of a problem if there is a steady stream of new products to take their place.
But the question is whether the new duo will arrive in time to stop the typical 80% plunge in sales that occurs when a drug goes off-patent.
All of which would seem to leave Bayer in a bind: Slash margins to meet the U.S. government's price target or let the drug go off-patent early.
The reason to ask the question was because of a study called ENHANCE, which showed no benefit to the arteries when Zetia was added to the off-patent Zocor.
Blockbusters, such as Eli Lilly's Prozac, went off-patent and drug makers came under public pressure to soften their stance on drug pricing and patent enforcement in poor countries.
Product A was about to go off-patent and become available as a generic, and we were trying to anticipate the effect this would have on sales of Product B, still on patent.
Miami-based Ivax (nyse: IVX - news - people) said today that it was supplying the U.S. government with 1.2 billion pills of doxacycline, an off-patent antibiotic used to treat anthrax.
Nonetheless, Berry says that most companies are "making solid progress" in development and clinical trials and that Big Pharma, with pipelines running dry and blockbuster drugs coming off-patent, needs biotech partners more than ever.
His biggest concern is that "a very high percentage of our revenue is going to go off-patent within the next product cycle, " meaning in seven years, the time it takes to develop a new drug.
Paul Wicks, a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.
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In the U.S. generic companies can sell off-patent products immediately, but they have to compensate the company that originally registered the chemical with the Environmental Protection Agency--Monsanto in this case--for the data showing the product's safety and efficacy.
Merck (nyse: MRK - news - people ) and Schering (nyse: SGP - news - people ) already sell a medicine, Vytorin, that combines Zetia with Merck's off-patent cholesterol medicine Zocor, once Lipitor's main rival.
Lilly (nyse: LLY - news - people ), which built a powerful presence in psychiatric drugs first with its now off-patent Prozac and now with antipsychotic Zyprexa, is following suit with what appears to be an even broader system for disclosing data.
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