Aurobindo Pharma Limited — Updates, 12-04-2025: Press Release

Aurobindo Pharma has received final approval from the USFDA to manufacture and market Rivaroxaban Tablets USP, 2.5 mg, which is bioequivalent to the reference drug XARELTO®. The product launch is anticipated in Q1FY26. The US market for Rivaroxaban Tablets USP, 2.5mg is estimated at approximately USD 447 million for the twelve months ending February 2025. Additionally, Aurobindo has received tentative approval for the other strengths of Rivaroxaban Tablets USP—10 mg, 15 mg, and 20 mg. The total market potential for all strengths is projected to be USD 8.5 billion for the same period. This approval enhances Aurobindo’s portfolio to a total of 540 ANDA approvals, which could significantly impact future revenues and market positioning, presenting a positive outlook for growth in the competitive pharmaceutical landscape.