Alvogen to market Natco’s generic Tamiflu capsules until 2017

Natco Pharma Limited and Alvogen, 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 have settled the patent infringement suit filed by Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech,
Inc. against Alvogen and Natco in New Jersey District Court (2:11-cv-04969-SDW–MCA).

On Monday, Indian Natco has informed that it got tentative approval from the FDA 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.