Lupin Gains FDA Nod for Epilepsy Drug, Secures 180-Day Exclusivity

Lupin Limited, a leading global pharmaceutical company, has announced the launch of Eslicarbazepine Acetate Tablets in the U.S. following approval from the U.S. Food and Drug Administration (FDA).  

The launch includes 200 mg, 400 mg, 600 mg, and 800 mg strengths. These tablets are the generic equivalent of Aptiom®, originally developed by Sumitomo Pharma America, Inc. 

Generic Exclusivity and Market Potential 

Lupin is one of the first companies to file an Abbreviated New Drug Application (ANDA) for this product and has secured 180 days of shared generic exclusivity. This strategic positioning allows Lupin early entry into a lucrative market. According to IQVIA MAT data for March 2025, the reference drug Aptiom® generated estimated annual sales of USD 395 million in the U.S. 

Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients aged 4 years and older. The launch enhances Lupin’s neurology portfolio and supports improved access to epilepsy treatment options. 

Lupin Updates Timeline for Slump Sale Transactions 

Meanwhile, Lupin has revised the timeline for two key slump sale transactions previously disclosed to the exchanges. The Business Transfer Agreement (BTA) for the transfer of its API R&D Division to Lupin Manufacturing Solutions Limited (LMSL) is now expected to be executed by June 30, 2025, instead of the earlier communicated April 30, 2025.  

Similarly, the BTA for transferring its Over-the-Counter Consumer Healthcare Business to LupinLife Consumer Healthcare Limited (LCHL) is also expected to be signed by June 30, 2025, or on a mutually agreed later date. 

Lupin Share Price Performance 

On May 7, 2025, Lupin share price opened at ₹2,025.10 and closed at ₹2,073.00, up by 1.17%. The stock price touched its day’s high at ₹2,074.90. 

Also Read: Lupin Posted About the US Launch of gTolvaptan With $200 Million FY26 Potential! 

Conclusion 

With this launch, Lupin reinforces its commitment to delivering high-quality, affordable generics in the U.S. market while expanding its presence in the central nervous system (CNS) therapeutic area. The Board of Directors of the company will meet on Wednesday, May 14, 2025, to consider and approve the audited standalone and consolidated financial results for the quarter and year ended March 31, 2025, and to recommend a dividend, if any. 

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