Lupin Launches Topiramate Extended-Release Capsules in the United States

Rhea-AI Summary

Lupin (LUPIN) announced U.S. launch of Topiramate Extended-Release Capsules in 25 mg, 50 mg, 100 mg and 200 mg strengths following U.S. FDA approval of its ANDA. The product is bioequivalent to the reference listed drug Trokendi XR and carries an estimated U.S. annual market of USD 164 million (IQVIA MAT Dec 2025).

The approval covers indications for seizure treatment in patients aged 6 years and older and migraine prevention in patients 12 years and older.

Positive

• ANDA approval obtained from U.S. FDA for topiramate extended-release
• U.S. launch across four dosage strengths (25/50/100/200 mg)
• Bioequivalent to reference listed drug Trokendi XR
• Estimated U.S. market of USD 164 million (IQVIA MAT Dec 2025)

Negative

• None.

MUMBAI, India & NAPLES, Fla., Feb. 4, 2026 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced the launch of Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the U.S. FDA. 

 

 

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR® Extended-Release Capsules of Supernus Pharmaceuticals, Inc. (Supernus). It is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older, as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older, and for the preventive treatment of migraine in patients 12 years of age and older.

Topiramate Extended-Release Capsules has an estimated annual sale of USD 164 million in the U.S. (IQVIA MAT Dec 2025).

About Lupin 
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. 

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

*Safe Harbor Statement 

Trokendi XR® is a registered trademark of Supernus Pharmaceuticals, Inc.

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SOURCE Lupin Inc.

FAQ

What did Lupin announce about Topiramate extended-release (LUPIN) on February 4, 2026?

Lupin launched Topiramate Extended-Release Capsules in the U.S. after ANDA approval. According to Lupin, the product is bioequivalent to Trokendi XR and is available in 25, 50, 100 and 200 mg strengths for approved seizure and migraine indications.

Which indications does Lupin's Topiramate extended-release (LUPIN) cover in the U.S.?

The drug is indicated for seizures and migraine prevention in specified ages. According to Lupin, it covers initial monotherapy and adjunctive therapy for seizures from age 6 and migraine prevention from age 12.

How large is the U.S. market for Topiramate extended-release that Lupin (LUPIN) entered?

The U.S. market for extended-release topiramate is estimated at about USD 164 million annually. According to Lupin, the USD 164 million figure is sourced to IQVIA MAT Dec 2025 for the U.S. market.

What strengths of Topiramate extended-release did Lupin (LUPIN) introduce in the United States?

Lupin launched four dosage strengths: 25 mg, 50 mg, 100 mg and 200 mg. According to Lupin, those strengths match the approved product profile and support multiple patient dosing needs for seizure and migraine indications.

Is Lupin's Topiramate extended-release equivalent to a branded product in the U.S. market?

Yes. Lupin's product is bioequivalent to the reference listed drug Trokendi XR. According to Lupin, the ANDA approval confirms bioequivalence to the RLD for the indicated uses noted in the approval.