U.S. FDA nod for Lupin's generic of Janssen Pharma's blood thinner tablets
Drugmaker Lupin has received U.S. Food and Drug Administration (U.S. FDA) approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, its generic version of Janssen Pharmaceuticals' blood thinner tablet Xarelto.
The product will be manufactured at its Aurangabad facility. The approved product had an estimated annual sales of $8,052 million in the U.S., Lupin said citing IQVIA MAT March 2025 numbers. Rivaroxaban Tablets USP are indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation and for treatment of deep vein thrombosis as well as pulmonary embolism, it said.
Rivaroxaban Tablets are bioequivalent to Xarelto, which Jannsen said is a blood thinner to treat and help prevent blood clots related to certain conditions involving the heart and blood vessels.
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