Drug firm Lupin Ltd on Friday (March 7) said it has launched rivaroxaban tablets USP, 2.5 mg, in the US market following final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA).
“Lupin today announced that it has launched Rivaroxaban Tablets USP, 2.5 mg, following the final approval of its Abbreviated New Drug Application from the U.S. FDA,” according to a stock exchange filing.
The drug is a generic equivalent of Xarelto 2.5 mg, originally developed by Janssen Pharmaceuticals, Inc.
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It is indicated for reducing the risk of major cardiovascular events in patients with coronary artery disease (CAD) and major thrombotic vascular events in patients with peripheral artery disease (PAD), including those who have undergone lower extremity revascularisation due to symptomatic PAD.
According to IQVIA MAT data for January 2025, rivaroxaban tablets USP, 2.5 mg, had estimated annual sales of $446 million in the US. With this launch, Lupin strengthens its presence in the high-value anticoagulant market.
Upbeat Q3
For the third quarter, the company reported a profit after tax of ₹8,589 crore, a 38.8% increase from the previous year’s ₹6,187 crore. Its total revenue from operations was up 102.7% at ₹57,677 crore from last fiscal year’s ₹51,974 crore.
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The company’s EBITDA (earnings before interest, tax, depreciation and amortisation) was up 25.1% in the third quarter at ₹14,096 crore against ₹10,673 crore YoY. Lupin’s EBITDA margin expanded to 21.1% in the December quarter against the previous year’s 21%.
Shares of Lupin Ltd ended at ₹2,020.30, up by ₹0.85, or 0.042%, on the BSE.
