HYDERABAD: Natco Pharma Ltd today said it has received final approval for its Abbreviated New Drug Application (ANDA) for generic versions of Tamiflu oral capsules (Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg, from the US Food and Drug Administration.
“Natco and its marketing partner Alvogen are the first generic players to receive this approval,” Natco said in a regulatory filing.
Tamiflu is used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. Tamiflu can also reduce the chance of getting the flu in people 1 year and older.
Earlier in December, 2015, Natco and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc.
Under the terms of the settlement, Natco’s partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period.
Tamiflu oral capsules had US sales of approximately USD 403 million for twelve months ending December 2015, according to IMS Health, Natco said.