Lupin Limited has announced the launch of Topiramate Extended-Release Capsules in the United States after receiving approval for its Abbreviated New Drug Application from the U.S. Food and Drug Administration.
The product is available in 25 mg, 50 mg, 100 mg, and 200 mg strengths. Lupin’s Topiramate Extended-Release Capsules are bioequivalent to Trokendi XR® Extended-Release Capsules, the reference listed drug from Supernus Pharmaceuticals.
The medication is indicated as initial monotherapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures in patients aged six years and older. It is also approved as adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in the same age group. In addition, the drug is indicated for the preventive treatment of migraine in patients aged 12 years and above.
According to industry estimates, Topiramate Extended-Release Capsules generate annual sales of approximately USD 164 million in the US, positioning the launch as a significant addition to Lupin’s neurology portfolio in the American market.
