FDA Greenlights First Rivaroxaban Generics (2.5 mg): Daily Dose

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On March 5, 2025, we reported on the US FDA approval of the first generic formulations of the anticoagulant rivaroxaban (Xarelto), 2.5 mg tablets.

The approval

Rivaroxaban tablets are indicated to reduce the risk of major cardiovascular (CV) events in adults with coronary artery disease (CAD) as well as reduce the risk of major vascular thrombotic events in those with peripheral artery disease (PAD). The latter group includes individuals who have recently had a lower extremity revascularization to alleviate symptomatic PAD.

Rivaroxaban, developed by Bayer and marketed in the US by Janssen Pharmaceuticals, was first approved by the FDA at a 10-mg dose in 2011 for the prevention of deep vein thrombosis (DVT) in adults undergoing joint replacement surgery, ie, of the hip or knee. Subsequent label expansions solidified a role for rivaroxaban in cardiovascular prevention. In 2017, the FDA approved a 2.5 mg twice-daily dose in combination with aspirin for reducing major CV events in adults with CAD or PAD. This label expansion was based on findings from the COMPASS⁴ trial demonstrating greater net clinical benefit of the low-dose rivaroxaban plus aspirin than of aspirin monotherapy in adults with stable atherosclerotic disease. A series of additional approvals followed including use in hospitalized, acutely ill patients at risk for VTE (2020) and use in the pediatric population treatment and prevention of VTE recurrence (2021).

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