Lupin gets USFDA nod for Topiramate Extended Release Capsules for seizures
Mumbai: Global pharma major Lupin Limited today announced that the Company has received approval from the United States Food and Drug Administration (U.S. 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.
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.
Topiramate Extended-Release Capsules (RLD Trokendi XR) had an estimated annual sale of USD 253 million in the U.S. (IQVIA MAT May 2024).
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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin bags USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution(OTC)
