Lupin bags USFDA nod for Eslicarbazepine Acetate Tablets for partial-onset seizures
Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, to market a generic equivalent of Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc.
Lupin is one of the first ANDA applicants and may be eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s Pithampur facility in India.
Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Partial-onset seizures, also known as focal seizures, are a type of seizure that originates in one specific area of the brain. These seizures can cause a variety of symptoms depending on the part of the brain affected and the extent of the seizure activity.
Eslicarbazepine Acetate Tablets (RLD Aptiom) had estimated annual sales of USD 354 million in the U.S. (IQVIA MAT January 2024).
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Lupin is a 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 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
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