Glenmark Gets Green Light for Generic Topiramate Capsules from USFDA

Glenmark Pharmaceuticals Ltd has announced final approval from the USFDA for its generic Topiramate capsules, used to treat seizures. These capsules, available in 15 mg and 25 mg strengths, are bioequivalent to Topamax capsules by Janssen Pharmaceuticals. This addition boosts Glenmark's extensive US product portfolio.

Glenmark Pharmaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its generic Topiramate capsules, intended to treat certain types of seizure, the company announced on Wednesday.

The approval covers Topiramate capsules in 15 mg and 25 mg dosages. These capsules have been deemed bioequivalent and therapeutically equivalent to Janssen Pharmaceuticals Inc.'s Topamax capsules, Glenmark stated.

Glenmark Pharmaceuticals Inc., USA will distribute the capsules in the US market, which saw Topamax capsules achieve annual sales of approximately $21.9 million, according to IQVIATM data for the period ending in May 2024. Glenmark currently has 198 products authorized for the US market and 50 ANDAs pending USFDA approval.

Furthermore, the company aims to bolster its growth by exploring external development partnerships to enhance its existing pipeline and portfolio.