 "Natco Pharma hits 52-week high on USFDA nod for generic Tamiflu")
Natco Pharma has rallied 7% to Rs 650 also its 52-week high on the National Stock Exchange (NSE) in early morning trade, after the company announced that it has received final approval from the US drug regulator for generic versions of Tamiflu oral capsules.
The company announce final approval of abbreviated new drug application (ANDA) containing a paragraph IV certification filed with the U.S. 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.
According to IMS Health, Tamilflu oral capsules had U.S. sales of approximately $403 million for twelve months ending December 2015.
Natco Pharma and its marketing partner Alvogen are the first generic players to receive this approval, the company said in a press release.
Earlier in December, 2015, Natco Pharma 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 February 23, 2017.
The company announce final approval of abbreviated new drug application (ANDA) containing a paragraph IV certification filed with the U.S. 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.
According to IMS Health, Tamilflu oral capsules had U.S. sales of approximately $403 million for twelve months ending December 2015.
Natco Pharma and its marketing partner Alvogen are the first generic players to receive this approval, the company said in a press release.
Earlier in December, 2015, Natco Pharma 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 February 23, 2017.
At 09:41 am, the stock was up 5% at Rs 640 on the NSE. A combined 335,574 shares changed hands on the counter on the NSE and BSE.