Lupin Launches Topiramate Extended Release Capsules In The United States

06 February 2026 | Friday | News


With US FDA approval for its ANDA, Lupin Limited strengthens its US neurology portfolio by introducing a bioequivalent generic to Supernus’ Trokendi XR, targeting epilepsy and migraine with an addressable market of USD 164 million annually.

 Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN)  announced the launch of 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 U.S. FDA. 

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 USD 164 million in the U.S. (IQVIA MAT Dec 2025).

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