Aurobindo Pharma, a Hyderabad-based pharmaceutical company, has received final approval from the US Food and Drug Administration (USFDA) to produce and sell Generic Xarelto (Rivaroxaban Tablets USP, 2.5mg) in the United States.
This medicine is the generic version of Xarelto, a popular blood thinner originally developed by Janssen Pharmaceuticals. Aurobindo plans to launch the 2.5mg tablets in the first quarter of FY26 (April–June 2025).
According to data from IQVIA, the US market for the 2.5mg strength of Generic Xarelto is worth around $447 million for the 12 months ending February 2025. This approval is a big win for Aurobindo Pharma, helping it grow in the competitive US generics market.
In addition to the 2.5mg tablets, Aurobindo has also received tentative approvals from the USFDA for other strengths of Generic Xarelto – 10mg, 15mg, and 20mg. These higher doses open doors to a much bigger market, with the total US market for all strengths of Rivaroxaban estimated to be $8.5 billion.
Rivaroxaban is a widely used blood thinner (anticoagulant). It helps lower the risk of stroke and blood clots in people with nonvalvular atrial fibrillation. It is also used to treat deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent DVT after hip or knee replacement surgeries.
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With this new approval, Aurobindo Pharma now has a total of 540 approvals from the USFDA, which includes 521 final approvals and 19 tentative ones.
This move strengthens Aurobindo Pharma’s position in the US market and shows its growing focus on launching high-value generic medicines like Generic Xarelto.
