Natco Pharma receives final approval for generic version of TAMIFLU

04 Aug 2016 Evaluate

Natco Pharma has received final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (FDA) for generic versions of TAMIFLU oral capsules (Roche’s trade name for Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg. The pharma major and its marketing partner Alvogen are the first generic players to receive this approval. TAMIFLU oral capsules had US sales of approximately $403 million for twelve months ending December 2015, according to IMS Health.

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, which is February 23, 2017.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.



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