This is with reference to your email dated March 2, 2015, seeking clarification on the news item titled “Ranbaxy loses drug pleas in US”, which appeared in the Financial Express dated March 1, 2015.
In this regard, previously, we had informed you on November 21, 2014 that the Company had filed a complaint against the US FDA in D.C. Federal Court and in the first instance asking the Court for a temporary restraining order to prevent any further action by FDA until Ranbaxy’s case is decided, which was denied. Following that determination, the Court ordered the parties in the suit to prepare and file legal briefs addressing Ranbaxy’s request for a preliminary injunction and the defendants’ request for summary judgment on the merits. Prior to the decision by the Court, FDA rescinded our 180 day exclusivity for Esomeprazole magnesium delayed release capsule 20 mg and 40 mg. This was communicated to the Stock Exchanges vide our Statement dated January 27, 2015. 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.
