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(10 Mar 2025, 10:02)

Lupin launches Rivaroxaban drug in US

Lupin announced that it has launched Rivaroxaban tablets USP, 2.5 mg, in the US market following final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA).


The newly launched drug is bioequivalent to Xarelto 2.5 mg from Janssen Pharmaceuticals, Inc.

Rivaroxaban 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 revascularization 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.

Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lupin’s consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.

Shares of Lupin rose 0.69% to Rs 2,043 on the BSE.

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