Aurobindo Pharma bags USFDA nod for generic Xarelto, eyes $447 million US market

With this, Aurobindo Pharma’s cumulative USFDA approvals now stand at 540, including 521 final approvals and 19 tentative ones.

Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Rivaroxaban Tablets USP, 2.5mg, the generic equivalent of Janssen Pharmaceuticals’s blockbuster blood thinner, Xarelto.

The Hyderabad-based drugmaker plans to launch the product in the first quarter of FY26, it said in a press release on April 12.

The US market for this strength of Rivaroxaban is estimated to be around $447 million for the 12-month period ending February 2025, according to IQVIA data data cited by CNBC-TV18. The approval marks a strategic boost for Aurobindo as it looks to expand its presence in the lucrative US generics segment.

In addition to the final approval for the 2.5mg dosage, Aurobindo has also secured tentative approvals from the USFDA for Rivaroxaban tablets in 10mg, 15mg, and 20mg strengths. These higher dosages represent a significantly larger market opportunity, with the total US market for all strengths of Rivaroxaban valued at $8.5 billion for the same period, according to IQVIA data cited by CNBC-TV18.

Rivaroxaban is a widely prescribed anticoagulant used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also indicated for treating deep vein thrombosis (DVT), pulmonary embolism (PE), and for preventing DVT in patients undergoing hip or knee replacement surgeries.

With this, Aurobindo Pharma’s cumulative USFDA approvals now stand at 540, including 521 final approvals and 19 tentative ones.