Lupin expands US generics portfolio with Topiramate ER launch

Lupin today announced the U.S. launch of Topiramate Extended-Release Capsules, strengthening its position in the competitive generics space.

Another milestone event that occurred in the company regulatory environment was the Abbreviated New Drug Application (ANDA) of Lupin to the U.S. Food and Drug Administration that gave the company the go-ahead to introduce the product.

The new topiramate extended release capsules come in 25mg, 50mg, 100mg and 200mg doses. Lupin affirmed the product is bioequivalent to the listed drug Trokendi XR Extended-Release Capsules, which Supernus Pharmaceuticals in the United States market.

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The drug is prescribed as the first line treatment of partial-onset and primary generalized tonic-clonic seizures in subjects of 6 years and above. It is also sanctioned as an adjunct therapy on partial-onset seizures, where primary generalized tonic-clonic seizures and on Lennox-Gastaut syndrome related seizures, in the same group of age. Besides that, the drug is prescribed to preventive treatment of migraine in patients aged 12 years and above.

Topiramate Extended- Release Capsules has a sizeable market opportunity with this launch. Estimated annual sales of the product in the U.S. stood at USD 164 million, based on the IQVIA MAT data of December 2025.

The recent approval and launch also augments the Lupin portfolio of neurology and also builds on its interest in providing patients with high-quality and affordable treatment choices throughout the market in the U.S.