Glenmark gets FDA final approval to sell anti-epileptic drug in US

Hyderabad: Glenmark Pharmaceuticals Ltd. on Thursday said it has received final approval to sell its anti-epileptic drug in the US, after a tentative approval received in May 2015. Glenmark’s Rufinamide tablets are a generic version of Japanese drug maker Eisai Co. Ltd’s Banzel, used to treat epilepsy and its symptoms such as seizures.

The US Food and Drug Administration (FDA) has granted approval for the tablets in 200 and 400 milligram (mg) dosage forms, Glenmark said in a statement. The company said it is eligible for 180 days of shared generic drug marketing exclusivity for rufinamide tablets.

According to a Glenmark statement quoting US-healthcare information provider IMS Health, Banzel had sales of $155.1 million in the 12-month period ending March 2016.

The company didn’t specify the launch date.

Eisai and Glenmark entered into a settlement agreement to resolve their patent litigation relating to Banzel in the US in April 2015. As per the settlement, Glenmark will be permitted to market a generic version of Banzel in the US on 30 May 2022, or potentially earlier under certain circumstances.

Banzel, first approved by the FDA in 2008, will lose patent protection starting late 2018 and mid-2019, except for its pediatric patent, which will expire in 2023.

Hetero Labs Ltd, Lupin Ltd, Mylan Pharmaceuticals Inc. and Roxane Laboratories Inc. are other generic drug makers who have challenged patents of Banzel.

Glenmark said its current portfolio consists of 113 products authorized for distribution in the US and 63 ANDAs pending approval with FDA.

“In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio,” the company said.

At 2.25 pm, shares of Glenmark gained 1.31% and were trading at Rs.861 each on the BSE, while the benchmark Sensex declined 0.91% to 25,469.52 points.

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