Natco Pharma Ltd.

Natco Pharma and Alvogen, who have partnered on the first Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (USFDA) for generic versions of Tamiflu oral capsules (oseltamivir phosphate), 30 mg, 45 mg and 75 mg, have settled the patent infringement suit filed by Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche and Genentech, Inc. against Alvogen and Natco in New Jersey District Court.

The USFDA granted tentative approval to NATCO for the generic oseltamivir phosphate capsules on March 14, 2014. 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, 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.