The American drug regulator has revoked Ranbaxy Laboratories' 180-day exclusivity for selling a low cost version of AstraZeneca's blockbuster heartburn drug Nexium, as per a stock market disclosure.
“We have received a communication from USFDA that they are determined that Ranbaxy has forfeited its 180-day exclusivity for esomeprazole magnesium delayed release capsule 20 mg and 40 mg,” it stated.
Ranbaxy is disappointed with the result and is pursuing all available legal options to preserve its rights, the firm said.
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.
US FDA had said it made an error in granting approval given the compliance status of the plants which were to produce the generic versions of the blockbuster drugs.
The move 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 awaits regulatory clearances.
Last month a US court had found that an agreement between AstraZeneca and Ranbaxy to delay the launch of Nexium's generic was not anticompetitive. This came amidst widespread calls against such 'pay-for-delay' settlements which keep the cost of healthcare high in the world's top drug market.
In pay-for-delay arrangements, generic drugmakers are paid by an innovator drug company to delay launching a low-cost version of the branded product.
Meanwhile, Israel's Teva has been granted FDA approval for its own generic version of Nexium.
(Edited by Joby Puthuparampil Johnson)