Will a one-day deadline miss rob Ranbaxy Laboratories of some lucrative exclusivity rights? The Novartis ($NVS) generics unit Sandoz has petitioned the FDA to yank Ranbaxy's 180-day exclusive rights to sell a copycat version of the big-selling stomach drug Nexium.
At issue: Whether Feb. 4, 2008 was the last day Ranbaxy could win approval of its Nexium copy. As Business Today reports, Sandoz claims that the 30-month window for Ranbaxy to gain FDA's blessing expired on that day. Ranbaxy's Nexium approval came through on Feb. 5.
So, Sandoz says, Ranbaxy should forfeit its 180-exclusivity rights because it didn't get its tentative approval within the 30-month window. "Based on the apparent date on which Ranbaxy's ANDA was submitted to FDA and the date on which it received tentative approval, Ranbaxy has forfeited its 180-day exclusivity under forfeiture condition," the petition states.
Nexium's 2011 sales amounted to $6.2 billion in 2011, IMS Health figures show. Having 180 days to sell the only generic version would be a big money-maker; once other generics hit the market, price competition really sets in and the market fragments. The Indian drugmaker's exclusive right to sell copycat Lipitor was worth about $500 million.
- read the Business Today piece