Aurobindo Pharma, a generic drugmaker, has received final approval from the US FDA to manufacture and market Rivaroxaban Tablets USP in the strength of 2.5 mg. This approval is based on the company’s demonstration of bioequivalence and therapeutic equivalence to the reference listed drug Xarelto 2.5 mg of Janssen Pharmaceuticals Inc. The company plans to launch the product by June, following the approval.
Rivaroxaban Tablet USP is used to treat various conditions, including nonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and for the prophylaxis of blood clots in patients undergoing knee or hip replacement surgery. The approved product has an estimated US market size of $447 million for the 12 months ending February 2025.
Aurobindo Pharma has also received tentative approval from the US FDA for Rivaroxaban Tablets USP in strengths of 10 mg, 15 mg, and 20 mg. The estimated US market size for all strengths of Rivaroxaban tab USP is $8.5 billion for the 12 months ending February 2025.