Natco Pharma receives US FDA approval for generic Tamiflu capsules

Natco Pharma Limited 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. Natco and its marketing partner Alvogen are the first generic players to receive this approval.

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 paediatric exclusivity period listed in FDA’s Orange Book for US patent, which is February 23, 2017.

Tamiflu oral capsules had US sales of approximately $ 403 million for twelve months ending December 2015, according to IMS Health.