 "US court rejects Ranbaxy plea against US FDA")
According to a Reuters report, a US court has rejected Ranbaxy’s request to stop the launch of generics of heartburn pill, Nexium, and anti-viral, Valcyte. Ranbaxy had filed a lawsuit on November 11, 2014, in the District of Columbia in the US against the decision of US Food & Drug Administration (US FDA) to revoke approvals for the generic versions of Valcyte (marketed by Roche) and Nexium (marketed by Astrazenca).
After US FDA withdrew Ranbaxy approvals, the US drug regulator had granted Dr Reddy's Laboratories and US-based Endo International Plc the approval for making generic version of Valcyte.
Following this, Ranbaxy had approached the US court against US FDA for revoking tentative approvals granted to it for making generics of Valcyte and Nexium.
The latest verdict of the US court could have severe effect on Ranbaxy as some experts believe that loss of six-month exclusivity period for two drugs (Valcyte and Nexium) in the US market could cost Ranbaxy as much as $200 million in revenue.
According Reuters report, Endo had already launched its generic version of Valcyte, while Dr Reddy’s was expected to market the drug in the US very shortly.
After US FDA withdrew Ranbaxy approvals, the US drug regulator had granted Dr Reddy's Laboratories and US-based Endo International Plc the approval for making generic version of Valcyte.
Following this, Ranbaxy had approached the US court against US FDA for revoking tentative approvals granted to it for making generics of Valcyte and Nexium.
The latest verdict of the US court could have severe effect on Ranbaxy as some experts believe that loss of six-month exclusivity period for two drugs (Valcyte and Nexium) in the US market could cost Ranbaxy as much as $200 million in revenue.
According Reuters report, Endo had already launched its generic version of Valcyte, while Dr Reddy’s was expected to market the drug in the US very shortly.