Lupin Receives US FDA Approval for Topiramate ER Capsules

Lupin Receives US FDA Approval for Topiramate ER Capsules

By, Admin 13 July 2024

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for topiramate extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent of Trokendi XR extended-release capsules, 25 mg, 50 mg, 100 mg, and 200 mg, of Supernus Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Indication

Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.

Estimated Annual Sale

Topiramate extended-release capsules (Trokendi XR) had an estimated annual sale of USD 253 million in the US (IQVIA MAT May 2024).

About Lupin

  • Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 
  • The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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