Ranbaxy loses exclusive rights to produce generic stomach drugs

Ranbaxy, the home-grown drug major, on Tuesday said that the US Food and Drug Administration (US FDA) has determined that the company has forfeited its 180 days exclusivity for stomach and esophagus problems treatment tablets.

"We have now received a communication from US FDA that they have determined that Ranbaxy has forfeited its 180 days exclusivity for esomeprazole magnesium delayed-release capsules," the company said in a filing to the Bombay Stock Exchange (BSE).

Ranbaxy said it was disappointed with the result and was pursuing all available legal options to preserve its rights.

Esomeprazole is used for treatment of certain stomach and esophagus problems such as acid reflux and ulcers.

In November 2014, the US drug regulator revoked its tentative approvals for Ranbaxy's generic anti-viral drug valganciclovir hydrochloride and esomeprazole magnesium delayed-release capsules 20 mg and 40 mg.

In November, the communication from US FDA said that Ranbaxy's abbreviated new drug application (ANDAs) of concern did not have any data integrity issues. However, it added that its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted.

Shares of Ranbaxy were trading at 8.55 points (or 1.21 per cent) lower, at Rs 697.70 a piece at 2:07 pm on the BSE.