US court quashes Ranbaxy’s plea against FDA on Nexium, Valcyte generic

A US court has dismissed a plea by Ranbaxy challenging the American drug regulator's move to revoke the 180-day exclusivity granted to the Indian pharma major for selling low-cost copies of two blockbuster drugs—AstraZeneca’s Nexium and Roche AG's Valcyte.

Daiichi Sankyo-controlled Ranbaxy Laboratories had sued the US Food & Drug Administration (FDA) for revoking approvals granted to it to launch copies of the two drugs last November. Its previous plea for a temporary restraining order to prevent any further action by FDA until Ranbaxy's case is decided was denied.

“The court has now issued an opinion indicating that it was (i) denying Ranbaxy's request for preliminary injunction and (ii) granting defendants' requests for summary judgment on the merits. In effect, the court's decision upheld the status quo that FDA had created by rescinding Ranbaxy's tentative approvals and forfeiting our 180 day exclusivities on Valganciclovir and Esomeprazole in November, 2014,” Ranbaxy disclosed on Tuesday.

Earlier, US FDA had revoked Ranbaxy's tentative approval for selling generic versions of Nexium and antiviral drug Valcyte in the world's largest drug market. Later, Israel's Teva was granted FDA approval for its own generic version of Nexium.

US FDA had said it made an error in granting approval given the compliance status of the Ranbaxy plants which were to produce the generic versions of the blockbuster drugs.

The development takes out a big revenue earning potential for the Indian drugmaker, which was also seen as a critical part of the proposed deal with Sun Pharma.

Sun Pharma had announced plans to acquire Daiichi Sankyo-controlled Ranbaxy in an all stock deal worth $4 billion, including debt. The proposed transaction is now in the final leg of execution.

(Edited by Joby Puthuparampil Johnson)

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