Lupin has launched topiramate extended-release capsules in strengths of 25 mg, 50 mg, 100 mg and 200 mg in the United States after receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).

The newly launched capsules are bioequivalent to Supernus Pharmaceuticals’ reference listed drug, Trokendi XR extended-release capsules. The medication is indicated as initial monotherapy for partial-onset or primary generalised tonic-clonic seizures in patients aged six years and older. It is also approved as adjunctive therapy for partial-onset seizures, primary generalised tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome in patients aged six years and above. In addition, the drug is indicated for the preventive treatment of migraine in patients aged 12 years and older.

According to IQVIA MAT data for December 2025, the reference product recorded estimated annual sales of approximately USD 164 million in the US market.

With this launch, Lupin continues to expand its US generics portfolio, strengthening its presence in the neurology segment and enhancing access to affordable treatment options for patients with epilepsy and migraine.