Home / Generics / News / Glenmark gains approval for anti-epileptic generic

Glenmark gains approval for anti-epileptic generic Posted 24/06/2016

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 19 May 2016 that it had received final approval from the US Food and Drug administration (FDA) for a generic version of Eisai’s epilepsy treatment Banzel (rufinamide).

Rufinamide is an anti-convulsant medication. It is used in combination with other medication and therapy to treat Lennox–Gastaut syndrome and various other seizure disorders.

Glenmark announced the FDA approval for its 200 and 400 mg strength rufinamide tablets in a BSE (Bombay Stock Exchange) filing on 19 May 2016. The company also believes that it was one of the first applicants to submit a substantially complete abbreviated new drug application (ANDA) to FDA, which could give it the right to 180-days of market exclusivity in the US.

The news of the approval followed the settlement of litigation over infringement of Banzel’s patent between Eisai and Glenmark in April 2016. The settlement allows Glenmark to market a generic version of Banzel in the US from 30 May 2022, or earlier under certain circumstances.

According to IMS Health, for the 12 months ending March 2016, Banzel had annual sales of approximately US$155.1 million.

Glenmark currently has 113 products approved in the US and a further 63 ANDA’s pending approval with FDA.

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Source: BSE India, Glenmark

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