Alembic Pharmaceuticals Limited announced on May 15 that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths.
These tablets are therapeutically equivalent to Xarelto, a product marketed by Janssen Pharmaceuticals, Inc., and are used to reduce the risk of major cardiovascular and thrombotic vascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD).
The company plans to launch the 2.5 mg strength in the first quarter of FY26. According to IQVIA, the estimated market size for the 2.5 mg dosage in the U.S. is $445 million for the 12 months ending March 2025, while the market size for the 10 mg, 15 mg, and 20 mg strengths collectively stands at $8,052 million.
With this approval, Alembic now holds a cumulative total of 222 ANDA approvals, which includes 198 final approvals and 24 tentative approvals from the USFDA.
Alembic Pharmaceuticals, headquartered in Vadodara, India, is a vertically integrated pharmaceutical company engaged in manufacturing and marketing of generic drugs globally. The company has over 5,200 field personnel and a well-established brand presence in the Indian generics market.
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