Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Rivaroxaban Tablets USP, 2.5mg, which is the generic version of Janssen Pharmaceuticals’ widely-used blood thinner, Xarelto.

The Hyderabad-based pharmaceutical company plans to roll out the product in the first quarter of FY26. The 2.5mg dosage alone is expected to tap into a US market worth around $447 million for the 12 months ending February 2025, as per IQVIA data. This marks a significant step forward in Aurobindo’s expansion strategy in the high-value US generics market.

Besides the final approval for the 2.5mg tablets, Aurobindo has also secured tentative USFDA approvals for Rivaroxaban in 10mg, 15mg, and 20mg strengths. These higher strengths open doors to a much larger market, with total US sales for all Rivaroxaban strengths estimated at $8.5 billion during the same period.

Rivaroxaban is a popular anticoagulant prescribed to prevent strokes and systemic embolism in patients with nonvalvular atrial fibrillation. It’s also used for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to prevent DVT in patients undergoing hip or knee replacement surgery.

With this latest approval, Aurobindo’s total USFDA approvals have reached 540, comprising 521 final and 19 tentative clearances.

Curious About Aurobindo Pharma Ltd? Ask the Analyst.

The future of investing is here!
Unicorn Signals leverages advanced AI technology to provide you with powerful market predictions and actionable stock scans. Download the app todayand 10x your trading & investing journey!