Lupin Launches Epilepsy, Migraine Drug Topiramate XR in US, Targets USD 164 Million Market
Mumbai: Lupin Limited has announced the launch of Topiramate Extended-Release Capsules in the United States after receiving approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (USFDA).
According to the company, the newly launched product is available in strengths of 25 mg, 50 mg, 100 mg, and 200 mg. Lupin stated that its Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug Trokendi XR® Extended-Release Capsules, marketed by Supernus Pharmaceuticals, Inc.
The drug is indicated as initial monotherapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures in patients six years of age and older. It is also approved as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients aged six years and above. In addition, the medication is indicated for the preventive treatment of migraine in patients 12 years of age and older.
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Lupin highlighted the commercial potential of the product, noting that Topiramate Extended-Release Capsules recorded estimated annual sales of USD 164 million in the US, based on IQVIA MAT data for December 2025.
Headquartered in Mumbai, Lupin Limited is a global pharmaceutical company with products distributed across more than 100 markets worldwide. The company operates 15 manufacturing sites and seven research centers globally, supported by a workforce of over 24,000 professionals. Lupin has a strong presence across multiple therapy areas, including central nervous system, respiratory, cardiovascular, anti-diabetic, gastrointestinal, anti-infective, and women’s health.
