Natco Pharma has received final nod from the US health regulator 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 (USFDA) for generic versions of Tamiflu oral capsules...", Natco Pharma said in a filing to BSE.
The approval is for the capsules in the strengths of 30 mg, 45 mg and 75 mg, it added.
The company's capsules are generic versions of Roche's Tamiflu capsules.
"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 USD 403 million for 12 months ending December 2015, it 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.
Natco stock was trading 3.1 per cent up at Rs 625.20 on BSE.
