Generic drugmaker Mylan ($MYL), impatient that money is sitting on the table, has sued the FDA to try to snatch the rights to produce a generic of Novartis' ($NVS) blockbuster blood pressure med, Diovan.
Ranbaxy Laboratories, which is operating under a consent decree with federal regulators and recently recalled 41 lots of generic Lipitor, has a 6-month exclusive on the generic. But while the patent slipped away in September, the FDA has yet to sign off on the Indian generic maker's copy.
Of course, this is like manna from heaven for Novartis, which expected to see its sales of the blockbuster eroded by a copy. It sold $1.9 billion worth of Diovan in the U.S. last year, The New York Times reports. However, if Mylan prevails in its lawsuit, then there are several other generics makers in line to flood the market with generic Diovan. If Ranbaxy prevails, there will be pain--but much less--for another 180 days. The FDA refused to tell the newspaper what the holdup is, and Ranbaxy says only that it is ready and waiting to get into the market with the drug.
Mylan, which earlier this year unsuccessfully challenged Ranbaxy's first-to-market rights on generic Lipitor, said under the exclusivity law, the FDA is supposed to approve a drug within 30 months of an application. Ranbaxy has yet to get approval for generic Diovan months past that deadline. And Mylan has what it needs to get into the market immediately. In September, it began making Diovan HCT, a combo of Diovan and a diuretic. It says in its suit that the FDA is acting capriciously. The FDA can grant exceptions, and a federal judge in Washington, DC, will get a chance today to say who is right.
- read the New York Times story
Special Report: Novartis - 10 Largest U.S. Patent Losses