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7 Aug 2016

FDA approves first generic version of influenza drug

Natco receives approval for generic Tamiflu.

Natco Pharma has received final approval of its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the 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 pediatric exclusivity period listed in FDA’s Orange Book for U.S. Patent No. 5,763,483, which is 23 February 2017. Tamiflu oral capsules had US sales of approximately $403 million for 12 months ending December 2015, according to IMS Health.

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