Lupin unveils heart drug Rivaroxaban in US

Mumbai: Global pharma major Lupin Limited has announced that it has launched Rivaroxaban Tablets USP, 2.5 mg, following the final approval of its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (U.S. FDA).

Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto Tablets, 2.5 mg of JanssenPharmaceuticals, Inc..

It is indicated

• to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)

• to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD.

Rivaroxaban Tablets USP, 2.5 mg (RLD Xarelto) had estimated annual sales of USD 446 million in the U.S. (IQVIA MAT January 2025).

Medical Dialogues team had earlier reported that Lupin had received approval from the U.S.FDA for its ANDA, Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.

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Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

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