One of Pfizer's top-selling products is suddenly vulnerable to generic competition 18 months earlier than expected. A U.S. court nixed a key Celebrex patent, putting the pain drug up for a sales fight in May. And generics makers Mylan and Actavis are promising to launch their versions as soon as Pfizer's monopoly expires.
AstraZeneca may get lucky with Nexium. That's thanks to the embattled Ranbaxy Laboratories, the Indian generics maker that could launch a copycat version May 27.
The largest drugstore chains have been in a legal battle with Pfizer, accusing it of conspiring to keep generics of its antidepressant Effexor XR out of their stores for years. Now they will have to deal with losing some of the real thing. Pfizer is recalling three lots of the drug after a pharmacist discovered a capsule of one of Pfizer's heart pills in an Effexor XR bottle, a potentially fatal combo.
Teva Pharmaceutical Industries is trying to throw up yet another hurdle to a generic version of its blockbuster multiple sclerosis drug Copaxone from India's Natco Pharmaceuticals.
Generic drug companies are fighting back against a new FDA proposal that would require them to update product labeling as soon as they learn of new safety information. The rule would essentially overturn a 30-year-old law--and put companies on the hook for liability lawsuits.
In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
Generics make up about 80% of the drugs U.S. consumers use, but there has long been questions about whether some of them work as well as the products they mimic. Now the FDA is finding out.
An EU drug-review committee recommended Teva Pharmaceutical Industries' knockoff version of the AstraZeneca respiratory med Symbicort on Friday. With key patents already expired, Teva's DuoResp Spiromax could soon put AstraZeneca's brand under siege.
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.
Last year, Roche appeared to throw in the towel on its breast cancer drug Herceptin in India when it said it would not defend the patent there. But it has come back out swinging with a court action that has messed with this week's launch of a biosimilar from Mylan.