Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's Valcyte.
Ranbaxy said today that the FDA has withdrawn its 6-month exclusivity for Valcyte. It also said it had lost its tentative approval for AstraZeneca's heartburn blockbuster Nexium. Nexium went off patent in May and Valcyte went off patent last year.
Pfizer and Ranbaxy Laboratories persuaded a U.S. judge to toss out an antitrust lawsuit accusing them of conspiring to delay generic versions of the cholesterol-fighting blockbuster Lipitor.
Cheap Sovaldi is on the way, and it could very well be coming to an emerging market near you. Gilead has ironed out a licensing deal for the hep C wonder with 7 companies--including Mylan and Ranbaxy--and they'll bring low-cost copies to 91 developing countries.
Back in 2008, Indian generics maker Ranbaxy made a deal with AstraZeneca to launch its Nexium copycat in May of this year. So why are Americans still unable to buy cheap versions of the blockbuster heartburn pill, which brought in more than $2 billion in U.S. sales last year?
The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories. It is also validation for the decision by Sun Pharmaceutical's owner, billionaire Dilip Shanghvi, who struck a $3.2 billion deal to buy Ranbaxy despite its years of FDA entanglements over quality issues.
With its $3.2 billion buyout of Ranbaxy Laboratories, Sun Pharmaceutical is not only buying a business in need of serious manufacturing improvements, but one that is bleeding money as FDA bans keep it from launching exclusive generics for blockbusters like Novartis' Diovan and AstraZeneca's Nexium.
The inability of Ranbaxy Laboratories to get its generic of heart drug Diovan to market for 18 months has been a boon for Novartis. Not so much for consumers.
Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.
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.