Lupin Limited has informed the Exchange regarding a press release dated May 07, 2025, titled "Lupin Launches Eslicarbazepine Acetate Tablets in the United States".
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Lupin has launched Eslicarbazepine Acetate Tablets in 200 mg, 400 mg, 600 mg, and 800 mg strengths in the U.S. market after receiving approval of its Abbreviated New Drug Application (ANDA) from the U.S. FDA. The drug is a generic equivalent of Aptiom® (by Sumitomo Pharma America) and is used to treat partial-onset seizures in patients aged 4 and above. Lupin is one of the first ANDA applicants, making it eligible for 180 days of shared generic exclusivity. The reference brand had estimated annual U.S. sales of USD 395 million (IQVIA MAT March 2025), indicating a sizeable addressable market for the generic.
The launch strengthens Lupin's U.S. generics portfolio and could boost U.S. revenue in the near term, especially during the 180-day exclusivity window when competition is limited. Positive for the stock in the short run, though gains will depend on the share of the USD 395 million market Lupin is able to capture.