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Ranbaxy Loses Its Exclusivity For Stomach Treatment Drug

Purba DasJan 27, 2015, 15:50 IST

In a letter to the National Stock Exchange (NSE), Ranbaxy Laboratories Ltd has disclosed that the US healthcare watchdog Food and Drugs Administration (FDA) has informed that the company has lost its exclusive rights over stomach drugs Esomeprazole. The company received the communication from the US healthcare watchdog on January 27, 2015.

“We have now received a communication from the USFDA that they have determined that Ranbaxy has forfeited its 180 day exclusivity for esomeprazole magnesium delayed release capsule 20 mg and 40 mg,” the company said in its disclosure to the exchange.

It further added, “On November 4, 2014, we received a notice from the USFDA rescinding our tentative approvals for Esomeprazole magnesium delayed release capsule 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450mg.”

The company has expressed its disappointment over the latest development and is considering legal recourse to preserve its rights on the drugs.

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