Natco gets USFDA approval for generic version of Roche’s influenza drug Tamiflu
06 Aug 2016
Natco Pharma has received final approval from the US Food and Drug Administration (FDA) for generic Tamiflu capsules used for treatment of influenza in the American market with 180 days of exclusivity.
The company "has received final approval for abbreviated new drug application (ANDA) containing a paragraph IV certification filed with the United States Food and Drug Administration (US health regulator) for generic versions of Tamiflu oral capsules...", Natco Pharma said in a filing with the BSE.
Tamiflu is Roche's trade name for Oseltamivir Phosphate and the approval is for the capsules in the strengths of 30 mg, 45 mg and 75 mg, it added.
An antiviral prescription medicine, Tamiflu is used in the treatment of influenza type A and B (bird and swine flu).
"Natco and its marketing partner Alvogen are the first generic players to receive this approval," the Hyderabad-based firm said.
According to IMS Health, Tamiflu oral capsules had U S sales of approximately $403 million for 12 months ending December 2015, Natco Pharma said
"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," Natco said.
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 which is February 23, 2017, it added.
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 listed in FDA's Orange Book for US Patent No 5,763,483, which is 23 February 2017.
