Lupin Limited has introduced Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA).
A Bioequivalent Alternative to Xarelto
Lupin’s Rivaroxaban Tablets USP, 2.5 mg are bioequivalent to Xarelto Tablets, 2.5 mg, developed by Janssen Pharmaceuticals, Inc. The medication is approved for:
Reducing the risk of major cardiovascular events in patients with coronary artery disease (CAD).
Lowering the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including those who have undergone recent lower extremity revascularization due to symptomatic PAD.
Market Potential and Sales Estimates
According to IQVIA MAT (January 2025), Rivaroxaban Tablets USP, 2.5 mg (Reference Listed Drug: Xarelto) recorded estimated annual sales of $446 million in the US.
Lupin’s Global Presence
Headquartered in Mumbai, India, Lupin Limited is a global pharmaceutical leader with a presence in over 100 markets worldwide. The company specializes in:
*Branded and generic formulations
*Complex generics
*Biotechnology products
*Active pharmaceutical ingredients (APIs)
As reported by pharmabiz.com, with this latest launch, Lupin continues to expand its portfolio, strengthening its position in the global pharmaceutical market.