Just hours after Bristol-Myers Squibb beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics of the blockbuster.
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
Hospira's reprieve from generic Precedex competition was short-lived. The U.S. district court that temporarily stopped Precedex generics has now decided to let the copycats roll. And that could mean Hospira will soon be sharpening its job-cutting ax.
Take a look at Novartis' second-quarter results for reasons why it engineered that big asset swap-and-sale with GlaxoSmithKline and Eli Lilly. The two units Novartis is unloading, vaccines and animal health, delivered weak sales for the quarter, dragging the company's top line below expectations.
The antitrust crackdown in pharma has moved to Australia. Once again, Pfizer finds itself in the middle of a legal fight over its efforts to hang onto Lipitor sales after the drug went off patent and faced competition from cheaper generics.
Pfizer's third-quarter results perfectly capture the forces shaping Big Pharma these days. Patent losses linger, with hundreds of millions lost to generic competition old and new. But Pfizer had growth in emerging markets and cancer sales to help stanch the flow, so overall sales only shrank by 2% to $12.6 billion. But shrink they did, and so did Pfizer's expectations for the full year.
Allergan is taking a tried-and-true route to fighting off competition for a key drug. It has asked the FDA to set a higher bar for approving generic versions. Like Sanofi and Teva before it, Allergan argues that knockoff versions--in this case, versions of its eye drug Restasis--should be tested in humans before approval, not just in a lab.
CEO Jeremy Levin, in addressing a disappointing quarter, had to acknowledge Thursday that his plans may not play out as he had anticipated after a U.S. appeals court last week invalidated the patent on Copaxone.
Eli Lilly's second-quarter earnings are up, but the company hasn't done it through rolling out new products or expanding its market. Bracing for the patent loss of top-seller Cymbalta, Lilly has implemented cost-cutting measures, slashed jobs and upped prices on the blockbuster antidepressant to do what drugmakers often do at the end of a patent's life: pump it for sales while they can.
The FDA says it won't need a clinical trial for approval of copycat versions, meaning the treatment for chronic dry eye could face cheaper rivals years earlier than previously expected.