Lupin Launches Eslicarbazepine Acetate in U.S. with 180-Day Exclusivity

Global pharmaceutical company Lupin Limited has announced the launch of Eslicarbazepine Acetate Tablets in the U.S. market, following the approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (FDA). The drug will be available in strengths of 200 mg, 400 mg, 600 mg, and 800 mg.

The tablets are the generic equivalent of Aptiom by Sumitomo Pharma America, Inc., and are indicated for the treatment of partial-onset seizures in patients aged four years and older. 

Lupin is among the first ANDA applicants and is therefore eligible for 180 days of shared generic exclusivity, giving the company a crucial early-mover advantage in a high-value segment.

According to IQVIA MAT March 2025, the Eslicarbazepine Acetate Tablets (RLD: Aptiom) market in the U.S. had estimated annual sales of USD 395 million. The launch positions Lupin strategically to tap into a significant revenue stream and expand its footprint in the central nervous system (CNS) segment.

With this launch, Lupin continues to strengthen its U.S. generics portfolio, which remains a key driver of its international business. The company has been focusing on complex generics and specialty products, and this latest approval underscores its capabilities in bringing high-quality, affordable medications to market.

This development marks another milestone in Lupin’s global growth and reinforces its commitment to expanding access to essential therapies.