Mylan ($MYL) has sued FDA for the right to sell a version of Novartis' ($NVS) blood pressure drug Diovan--right now. India's Ranbaxy Laboratories may have exclusive rights to market copycat Diovan for 6 months, Mylan figures, but Novartis' patent expired more than two weeks ago, and Ranbaxy's copy is MIA.
It feels like déja vù because it is. We've been through this before with Mylan and Ranbaxy, when Lipitor's expiration date neared and Ranbaxy's version didn't yet have FDA approval. Mylan lost out, because in the 11th hour, Ranbaxy did nail down regulatory clearance and launch its copy of the Pfizer ($PFE) drug.
But this time, Mylan has an extra bit of weight on its side. Not only has Diovan's patent expired without any generic competition, but rivals for a combo drug, Diovan HCT, have already launched, because Ranbaxy's exclusivity doesn't apply. And Mylan should know; it's one of the sellers.
Mylan claims that Ranbaxy forfeited its right to 6-month exclusivity because it didn't get FDA approval in time. "Ranbaxy failed to received tentative approval prior to the statutory 30-month forfeiture deadline, and no statutory exception to forfeiture applies," the company said in its suit (as quoted by Bloomberg).
Novartis must be hoping that Ranbaxy comes through. After all, if Mylan prevails in its suit, then there are several other generics makers in line to sell generic Diovan. They could all hit the market posthaste. But if Ranbaxy launches, its Diovan version will be the brand's only rival for the duration of that exclusivity period. And that means less price competition--and more sales--for both.
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