Global pharmaceutical company Lupin Limited has announced the launch of Eslicarbazepine Acetate Tablets in the United States following approval from the U.S. Food and Drug Administration (FDA).
The company launched the medication in four strengths - 200 mg, 400 mg, 600 mg, and 800 mg. Lupin is also among the first companies to file the Abbreviated New Drug Application (ANDA), making it eligible for 180 days of shared generic exclusivity in the U.S. market.
The tablets are the generic equivalent of Aptiom® by Sumitomo Pharma America, Inc. and are prescribed for the treatment of partial-onset seizures in patients aged four years and older.
Major Opportunity in the U.S. Pharma Market
According to IQVIA MAT March 2025 data, Aptiom® recorded estimated annual sales of nearly USD 395 million in the U.S., highlighting the market potential for Lupin’s newly launched generic version.
The launch strengthens Lupin’s presence in the highly competitive U.S. generics market and expands its portfolio in the central nervous system (CNS) therapy segment.
Supporting Affordable Healthcare Access
Generic medicines are essential for improving access to affordable treatment options for patients across the globe. By introducing Eslicarbazepine Acetate Tablets, Lupin aims to provide a cost-effective alternative for epilepsy patients requiring long-term seizure management.
The launch also reflects the company’s continued focus on delivering high-quality and accessible healthcare solutions worldwide.
About Lupin
Headquartered in Mumbai, India, Lupin operates in more than 100 countries and specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The company has a strong presence across several therapy areas, including respiratory, cardiovascular, anti-diabetic, gastrointestinal, anti-infective, central nervous system, and women’s health.
With 15 manufacturing facilities and seven research centers globally, Lupin continues to expand its innovation-driven healthcare ecosystem through subsidiaries focused on diagnostics, digital health, and manufacturing solutions.
As the demand for affordable generic medicines continues to rise, Lupin’s latest U.S. launch marks another significant step in strengthening its global pharmaceutical footprint.
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