 "Natco settles infringement suit for generic Tamiflu")
Natco Pharma Limited 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 (FDA) 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 Ltd and Genentech Inc against Alvogen and Natco in New Jersey District Court.
“On March 14, 2014, US FDA granted tentative approval to Natco for the generic oseltamivir phosphate capsules. 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 US Patent, which is February 23, 2017,” said Natco in a press statement.
“On March 14, 2014, US FDA granted tentative approval to Natco for the generic oseltamivir phosphate capsules. 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 US Patent, which is February 23, 2017,” said Natco in a press statement.