It is another swing and a miss for Mylan ($MYL). Twice now it has struck out in efforts to snatch away from Ranbaxy Laboratories the Indian drugmaker's 180-day exclusivity on a drug. The first time was for a generic of Pfizer's ($PFE) Lipitor and this time for a generic of Novartis' ($NVS) Diovan.
A federal court has dismissed Mylan's lawsuit against the FDA, saying the agency was not out of bounds in denying the generic drugmaker's request to make an exclusive of the heart drug, Bloomberg reports. It also said, given Mylan's size, failing to get the 6-month exclusive rights would not cause "irreparable harm."
Mylan had argued that the FDA is supposed to approve a drug within 30 months of an application and that Ranbaxy had forfeited its right to the 6-month lock by not getting its version signed off on within that time frame. Mylan was prepared to step immediately into the market because in September, it began making Diovan HCT, a combo of Diovan and a diuretic.
Mylan's loss is good news for Novartis, which sold $1.9 billion worth of Diovan in the U.S. last year. It means it continues to get full value from its branded version until the Ranbaxy generic hits the market and then has to share the space only with Ranbaxy for 180 days. If Mylan had won, a host of competitors would have rushed in with generics. Mylan tried a similar strategy last year. Ranbaxy was mired in the middle of manufacturing issues with the FDA and had yet to get its version of Lipitor approved and Mylan said it should be granted the exclusivity instead. The FDA finally signed off on Ranbaxy's drug and the Indian company was able to generate huge sales in the U.S. during the first 6 months.
It wasn't all bad news for Mylan today. It did announce that it had launched a version of Pfizer's Dilantin Chewable Tablets, which are used to treat seizures. Mylan, citing IMS Health stats, said the market for the drug in the U.S. was about $16.5 million for the 12 months that ended Sept. 30.
- read the Bloomberg story
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