Lupin Launches Topiramate Extended-Release Capsules in the United States

Lupin has launched Topiramate Extended-Release Capsules in the US in strengths of 25 mg, 50 mg, 100 mg, and 200 mg following approval of its Abbreviated New Drug Application (ANDA) by the US Food and Drug Administration. The product is bioequivalent to Trokendi XR and is indicated for the treatment of various seizure disorders and for the preventive treatment of migraine in eligible patients. The reference market for the product recorded sales of about USD 164 million in the US as of December 2025.

Therapeutic Scope and Indications

Topiramate Extended-Release Capsules are approved for use as initial monotherapy and 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. The drug is also indicated for migraine prevention in patients aged 12 years and older, expanding its clinical utility across neurology segments.

Strengthening Lupin’s US Generics Portfolio

The launch reinforces Lupin’s strategy to expand its presence in the US generics market through complex formulations and controlled-release products. Entry into a market with established demand and a defined reference product positions the company to enhance revenue opportunities while strengthening its neurology portfolio in regulated markets.