India's Supreme Court has called a temporary halt to Glenmark's production of generics of two Merck diabetes drugs but allowed continued sales of the local drugmaker's inventory through October or November.
It would appear that Sun Pharmaceuticals founder, Managing Director and CEO Dilip Shanghvi was not the buyer of Daiichi Sankyo's one-swoop sale of its 8.9% stake in the company it received for selling Ranbaxy Laboratories.
With Sun Pharmaceutical's $4 billion buyout of Ranbaxy Laboratories all but wrapped up, the combined company has plenty on its plate: get plants banned by the FDA in order, get more products approved and to the market and find $250 million in savings with minimal layoffs.
At least 5 India drugmakers are reported to be interested in the 7 drugs Sun Pharmaceuticals has to sell before it can close its yearlong acquisition of Ranbaxy Laboratories.
Ranbaxy Laboratories may soon be selling its generic minocycline antibacterial drug to Torrent Pharmaceuticals as a condition for U.S. approval for its merger with Sun Pharmaceuticals.
Last year Ranbaxy Laboratories persuaded the FDA to allow it to launch its exclusive of generic Diovan from its plant in New Jersey after the agency banned the Indian plant from which Ranbaxy would have made the drug. But with that workaround played out, and bans against four of its plants still in place, India's largest generic drugmaker saw earnings slip back into the red for the final quarter of the year.
Novartis took its first big hit from new Diovan generics during last year's third quarter, when Ranbaxy Laboratories finally won approval for its exclusive generic of the blood pressure pill. And it was indeed a big hit: a 76% drop in U.S. sales for the franchise, to $97 million.
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Ranbaxy said today that the FDA has withdrawn its 6-month exclusivity for Valcyte.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.