and will be able to market generic version of Tamiflu® oral capsules before expiration of pediatric exclusivity
Alvogen and Natco Pharma Limited (Natco), who 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, announced today that they have settled the patent infringement suit filed by Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. against Natco in New Jersey District Court (2:11-cv-04969-SDW–MCA).
FDA granted tentative approval for the generic oseltamivir phosphate capsules on March 14, 2014. Under the terms of the settlement, 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.