Lupin Limited has informed the Exchange regarding a press release dated Jun 07, 2025, titled "Lupin Receives Tentative Approval from U.S. FDA for Oxcarbazepine ER Tablets".
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Awaiting price reaction for this filing.
Lupin has received tentative approval from the U.S. FDA for its generic version of Oxcarbazepine Extended-Release (ER) Tablets in three strengths — 150 mg, 300 mg, and 600 mg. The product is bioequivalent to Supernus Pharmaceuticals' branded drug Oxtellar XR®, used for treating partial-onset seizures in patients aged 6 and above. The tablets will be manufactured at Lupin's Nagpur facility in India. The reference brand had estimated annual U.S. sales of USD 206 million, based on IQVIA data for the 12 months ending April 2025.
Positive for Lupin as it gains entry into a USD 206 million U.S. market for a neurology product. However, this is only a 'tentative' approval, meaning Lupin cannot launch the generic until existing patent or exclusivity barriers on Oxtellar XR® are resolved. The stock may see a mild positive reaction, but the real commercial benefit depends on when Lupin can actually start selling.