Express Pharma

Lupin launches Topiramate Extended-Release Capsules in the US

Launch follows FDA approval for ANDA

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Lupin today announced the launch of Topiramate Extended-Release Capsules in strengths of 25 mg, 50 mg, 100 mg, and 200 mg in the United States, following approval of its Abbreviated New Drug Application by the U.S. Food and Drug Administration.

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals, Inc. The product is indicated as initial monotherapy for the treatment of partial-onset or primary generalised tonic-clonic seizures in patients aged six years and above. It is also indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalised tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients aged six years and above. In addition, it is indicated for the preventive treatment of migraine in patients aged 12 years and above.

Topiramate Extended-Release Capsules has a sale figure of USD 164 million in the United States, as per IQVIA MAT December 2025 data.

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