Updated on 4 October 2012
Mylan sues FDA for Novartis' Diovan generic
Multinational pharmaceutical company Mylan sued the US Food and Drug Administration (FDA) for approval to sell a generic version of Novartis' blockbuster anti-hypertensive drug Diovan (valsartan). Novartis lost pediatric exclusivity for Diovan on September 21, 2012. According to Mylan, the FDA failed to grant approval for selling its generic valsartan despite Ranbaxy failing to get its 180-day marketing exclusivity for the drug.
Mylan filed a complaint and motion for a preliminary injunction against the FDA in the US district court of Columbia on October 2, 2012.
Diovan generated $5.7 billion in revenue for Novartis last year, according to the company's annual report. And Ranbaxy, which was eligible for the 180-day marketing exclusivity for filing the ANDA first, failed to receive tentative approval from the US FDA for its drug within 30 months of submission (by June 28, 2007). It received the tentative approval on October 25, 2007 (four months after the deadline), says the complaint filed by Mylan in court.
Mylan submitted an Abbreviated New Drug Application (ANDA) with the US FDA on September 15, 2008, for Valsartan Tablets, 40mg, 80mg, 160mg, and 320mg. According to Mylan, the company wrote to the FDA on July 24, 2012, seeking approval for valsartan upon expiration of Novartis' patent on the basis that Ranbaxy forfeited its exclusivity to obtain tentative approval within the statutory deadline. FDA, according to Mylan, did not respond to Mylan's July 24, 2012, correspondence.