Alembic Pharma Secures US Approval for Generic Anticonvulsant

Alembic Pharmaceuticals has received approval from the USFDA to market a generic version of the anticonvulsant medication Carbamazepine, equivalent to Novartis's Tegretol. The drug is used in treating seizures and trigeminal neuralgia, with a market size estimated at USD 32 million.

Alembic Pharmaceuticals announced on Thursday that it has obtained approval from the United States Food and Drug Administration (USFDA) to market a generic version of an anticonvulsant medication in the American market.

The pharmaceutical company has been cleared to distribute Carbamazepine tablets (USP, 200 mg), equivalent to the reference drug Tegretol by Novartis Pharmaceuticals. This medication is designed for use as an anticonvulsant, as well as for managing pain associated with trigeminal neuralgia.

According to data from IQVIA, the market size for Carbamazepine tablets USP, 200 mg is estimated at USD 32 million for the 12-month period ending December 2024. Meanwhile, Alembic Pharma's shares were noted to drop marginally by 0.21% to Rs 849.85 per share on the BSE.

(With inputs from agencies.)