Ranbaxy loses approvals, exclusivity of two drugs in US

Press Trust of India, New Delhi, March 3: Ranbaxy Laboratories’ tentative approvals for its generic versions of digestive disorder drug Nexium and antiviral Valcyte along with 180-days marketing exclusivity stands canceled following a US court decision.
The DC Federal Court in the US has upheld the decision of the USFDA for rescinding tentative approvals given to it for generic digestive disorder drug Nexium and antiviral Valcyte. “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,” Ranbaxy Laboratories said in a filing to BSE.
In effect, the company further said, “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.”
In November, Ranbaxy had sued USFDA over revoking an approval to sell generic versions of Nexium and Valcyte in the US and had also requested the court for a temporary restraining order asking the regulator not to give approvals for ANDAs of other companies for the two drugs.
The court had not earlier granted the company temporary restraining order to block the health regulator from approving other ANDAs for generic versions of the two drugs.
The domestic firm was expected to benefit greatly by the approvals and 180-days exclusivity to sell the generic versions of the two medicines in the US.
In 2008, Ranbaxy was granted approval by the USFDA to sell its generic copies in select doses of Astrazaneca’s Nexium and Roche’s Valcyte each with 180-days generic marketing exclusivity as and when the patents of the two branded drugs expired.
However, the company had run into trouble with the USFDA cracking down on it for failure to observe current GMPs (good manufacturing practices) at its Dewas and Paonta Sahib facilities.
It had in 2013 agreed to pay USD 500 million as settlement with the US authorities after admitting to “felony charges” following a consent decree it had signed earlier.
Ranbaxy Laboratories’ scrip was trading at Rs 736.10, up 1.85 per cent, on the BSE.

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