Alvogen and Natco settle infringement suit over Tamiflu

USA-based generics drugmaker Alvogen and India’s Natco Pharma, who have partnered on the first Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration for generic versions of Tamiflu oral capsules (oseltamivir phosphate), say they have settled the patent infringement suit filed by Gilead Sciences (Nasdaq: GILD) and with Roche (ROG: SIX) and its subsidiary Genentech against Natco in New Jersey District Court (2:11-cv-04969-SDW–MCA).

The 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 US Patent No 5,763,483, which is February 23, 2017.

Tamiflu was developed by Gilead, and receives royalties on the drug's sale from Roche and Genentech.