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Natco Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) containing a Para IV certification for generic versions of Tamiflu oral capsules (Roche’s trade name for Oseltamivir Phosphate).
The Hyderabad-based Natco and its marketing partner Alvogen were the first generic players to receive this approval, according to a release issued here on Thursday.
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 about $403 million for the 12 months ended December 2015, according to IMS Health.
Natco’s scrip gained 4.57 per cent on the Bombay Stock Exchange and is trading at Rs 634.10 on Thursday.
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