Under the terms of the settlement, Natco’s partner Alvogen will be able to market the oseltamivir phosphate capsules
Natco Pharma and its partner Alvogen have settled patent infringement suit with Gilead Sciences and others over Tamiflu, in a US court.
“Natco Pharma Ltd and Alvogen… have settled the patent infringement suit filed by Gilead Sciences, Hoffmann-La Roche, F Hoffmann-La Roche and Genentech … in New Jersey District Court,” Natco said in a regulatory filing.
Natco and Alvogen 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) of 30 mg, 45 mg and 75 mg strengths.
In March last year, US FDA had 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 paediatric exclusivity period listed… which is February 23, 2017,” it added.
In 2011, Natco had challenged Gilead’s patent on Tamiflu (Oseltamivir Phosphate) alleging that Gilead’s patent on the drug is invalid.
Tamiflu was developed by Gilead, which receives royalties on the drug’s sale from Roche Holding.