Glenmark Pharmaceuticals has received a tentative nod from the US health regulator for launching generic version of Sanofi-Aventis’ heart drug Multaq. The drug had achieved annual sales of around $425 million last year.

In a BSE filing, Glenmark said it “has been granted tentative approval by the US Food & Drug Administration (USFDA) for its Dronedarone Tablets, 400 mg, the generic version of Multaq Tablet, 400 mg of Sanofi-Aventis US LLC.”

However, the US FDA nod is tentative, which means the company cannot start selling the drug immediately even though it has met all required safety, quality and efficacy standards. Glenmark will be able to market the product as it is involved in a patent litigation with Sanofi in the district court of Delaware. Glenmark’s share price on Wednesday closed 2.8 per cent down at ₹906.65 per unit on the BSE.

“Glenmark believes that it is one of the first companies to have filed a substantially complete Abbreviated New Drug Applications (ANDA) and expects to be eligible for 180 days generic drug exclusivity upon final FDA approval,” the company added.

Sanofi-Aventis had filed the suit against Glenmark and Dublin-based Actavis (Watson) on February 26, 2014, in the US court seeking to prevent the two companies from launching the generic drugs.

In October, Reuters reported that Sanofi has stopped developing a potential multiple sclerosis drug licensed from Glenmark. Sanofi had licensed vatelizumab in 2011 in a deal worth over $600 million.

The company's current portfolio consists of 104 products authorised for distribution in the US marketplace and 62 ANDA pending approval with the USFDA.

For the quarter ended September 30, Glenmark reported a 20 per cent rise in its consolidated net profit at ₹198 crore against ₹165 crore a year ago. Consolidated revenue rose 13.6 per cent to ₹1,909 crore from ₹1,680 crore a year ago.

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