Lupin launches Topiramate Extended-Release Capsules in United States

05 Feb 2026 Evaluate

Lupin has launched Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the USFDA.

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals, Inc. (Supernus). It is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older, as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older, and for the preventive treatment of migraine in patients 12 years of age and older.

Topiramate Extended-Release Capsules has an estimated annual sale of $164 million in the U.S. (IQVIA MAT December 2025).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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