USFDA clears Alembic Pharma cardio drug Rivaroxaban, launch expected in next year
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-05-15 09:56 GMT | Update On 2025-05-15 09:56 GMT
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc..
Rivaroxaban tablets, 2.5mg, are indicated:
i) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD),
ii) 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.
According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of US$ 445 million for twelve months ending March 2025 and Alembic will be launching this strength in Q1FY26.
The estimated market size for remaining strengths of Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, is US$ 8,052 million for twelve months ending March 2025 according to IQVIA.
Alembic has a cumulative total of 222 ANDA approvals (198 final approvals and 24 tentative approvals) from USFDA.
This month, Medical Dialogues team also reported that the company received approval from the USFDA for cardiovascular drug Ticagrelor in 90 mg and 60 mg strengths, further strengthening its cardiovascular drug portfolio in the U.S. market. For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification.
Read also: Alembic Pharma bags USFDA nod for cardiovascular disease drug Ticagrelor in two strengths
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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