ARTICLE | Company News

Ranbaxy generics, gastrointestinal, infectious news

January 12, 2015 8:00 AM UTC

Ranbaxy filed a suit in the U.S. District Court for the District of Columbia alleging that FDA improperly concluded that the company forfeited its 180-day exclusivity for a generic version of Valcyte valganciclovir from Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland). Under the Hatch-Waxman Act, the first applicant to submit an ANDA for a generic version of an approved drug is entitled to 180 days of generic market exclusivity after patent expiration if FDA grants tentative approval to the ANDA within 30 months of its submission. In 2005, Ranbaxy submitted ANDAs to FDA for generic versions of Valcyte and Nexium esomeprazole from AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.). In 2008, FDA granted tentative approval to the ANDAs within 30 months of the respective submission dates. After reviewing an audit of Ranbaxy’s manufacturing facilities, the agency rescinded the tentative approvals in 2012, saying that the compliance status of the facilities was inadequate at the time of tentative approval. FDA then concluded that Ranbaxy forfeited its 180-day exclusivity for generic Valcyte because it did not receive tentative approval within 30 days of submission. The agency has not yet made a conclusion on the 180-day exclusivity status of Ranbaxy’s generic Nexium since no other generic has been approved.

Ranbaxy argues that FDA has no power to rescind a tentative approval, and even so, the requirement for 180-day exclusivity was already satisfied when agency first notified Ranbaxy of tentative approval. The company is seeking a declaration that Ranbaxy has 180-day exclusivity for generic Valcyte and an injunction preventing FDA from allowing the sale of any other generic Valcyte during the period. ...