Lupin Limited has informed the Exchange regarding a press release dated May 15, 2025, titled "Lupin Receives Approval from U.S. FDA for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg".
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Awaiting price reaction for this filing.
Lupin has received U.S. FDA approval for its generic version of Rivaroxaban Tablets in 10 mg, 15 mg, and 20 mg strengths. This is the generic equivalent of Janssen Pharmaceuticals' Xarelto®, a widely used blood thinner. The product will be manufactured at Lupin's Aurangabad facility in India. Rivaroxaban is indicated for preventing strokes, treating deep vein thrombosis (DVT), pulmonary embolism (PE), and several other blood-clot related conditions. The reference drug Xarelto® had estimated annual U.S. sales of around USD 8,052 million (about ₹67,000+ crore), according to IQVIA data for the 12 months ending March 2025, indicating a large addressable market for Lupin's generic.
This is a positive development for Lupin as it allows the company to enter a multi-billion dollar U.S. market with a high-demand generic drug, which could boost future U.S. revenues and margins. However, the actual revenue impact will depend on how quickly Lupin launches, the level of competition from other generic players, and pricing dynamics in the U.S. generic market.