Drug major Ranbaxy today said that the US health regulator has "determined" that the Indian drug manufacturer has forfeited its 180 days exclusivity for stomach and esophagus problems treatment tablets.
Drug major Ranbaxy today said that the US health regulator has "determined" that the Indian drug manufacturer 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 BSE filing.
Esomeprazole is used for treatment of certain stomach and esophagus problems such as acid reflux and ulcers.
Ranbaxy said it "is disappointed with the result and is pursuing all available legal options to preserve its rights."
In November 2014, US FDA 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 Food and Drug Administration (USFDA) 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 Rs 700.15 apiece, down 0.86 per cent from its previous close on the BSE.
Ranbaxy Labs stock price
On January 27, 2015, Ranbaxy Laboratories closed at Rs 706.90, up Rs 0.65, or 0.09 percent. The 52-week high of the share was Rs 714.20 and the 52-week low was Rs 306.05.
The company's trailing 12-month (TTM) EPS was at Rs 20.91 per share as per the quarter ended September 2014. The stock's price-to-earnings (P/E) ratio was 33.81. The latest book value of the company is Rs 25.82 per share. At current value, the price-to-book value of the company is 27.38.
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