Natco Pharma and Alvogen have settled the patent infringement suit filed by Gilead Sciences, Hoffmann-La Roche, F. Hoffmann-La Roche Ltd. and Genentech Inc. against them in New Jersey District Court.
Natco Pharma and Alvogen have partnered on the first 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 (oseltamivir phosphate), 30 mg, 45 mg and 75 mg.
FDA 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 for U.S. Patent No. 5,763,483, which is February 23, 2017.
