Lupin launches seizure drug eslicarbazepine acetate in US after FDA approval
Published on 07/05/2025 05:16 PM
Lupin launches seizure drug eslicarbazepine acetate in US after FDA approvalThe product, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths, is the generic equivalent of Sumitomo Pharma America’s Aptiom and is indicated for the treatment of partial-onset seizures in patients aged four years and above. Shares of Lupin Ltd ended at ₹2,066.90, up by ₹18, or 0.88%, on the BSE.By Jomy Jos Pullokaran May 7, 2025, 5:16:37 PM IST (Published)2 Min ReadDrug firm Lupin Limited on Wednesday (May 7) said it has launched eslicarbazepine acetate tablets in the US after securing approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA).
The product, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths, is the generic equivalent of Sumitomo Pharma America’s Aptiom and is indicated for the treatment of partial-onset seizures in patients aged four years and above.
Lupin is among the first ANDA applicants for the drug and is eligible for 180 days of shared generic exclusivity in the US market. This exclusivity period often provides a competitive edge by limiting the number of generic competitors in the initial phase of commercialisation.
Also Read: Lupin shares gain 3% after USFDA approval for $1.5 billion drug, 180-day exclusivity
According to IQVIA MAT data for March 2025, the reference listed drug (RLD), Aptiom, generated estimated annual sales of $395 million in the US.
Last month, Lupin launched gTolvaptan (the generic version of Jynarque) in the US, as Otsuka's exclusivity comes to an end. The company will enjoy a 180-day sole generic exclusivity, potentially extending further, and is expected to remain the only generic player for most of FY26.
With this launch, Lupin's FY26 revenue opportunity is estimated at $150-200 million. gTolvaptan could contribute over 25% to Lupin’s FY26 earnings, making it a key growth driver for the year. The launch also helps offset revenue loss from gMirabegron sales during FY26.
Also Read: Lupin gets USFDA’s Establishment Inspection Report for Nagpur injectable facility
Shares of Lupin Ltd ended at ₹2,066.90, up by ₹18, or 0.88%, on the BSE.
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