First Rivaroxaban Generics (2.5 mg) Get FDA Approval

The FDA announced on Tuesday approval of the first generic formulations of the anticoagulant rivaroxaban (Xarelto), 2.5 mg tablets.¹ The agency cleared generic versions of this lowest dose of the direct oral factor Xa inhibitor from the Sun Pharma subsidiary Taro Pharmaceuticals and Lupin.²

In news alert the FDA stated the indication for rivaroxaban tablets, 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.¹

"Monday's approval of the first generics of rivaroxaban, 2.5 mg, tablets will make a direct impact on American patients who rely on anticoagulant medications. Approving safe and effective generics to help provide patients more treatment options continues to be a priority for the FDA," the agency wrote in the alert.1

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.³ Also in 2011 the FDA approved the anticoagulant at doses of 15 and 20 mg daily for stroke prevention in adults with nonvalvular atrial fibrillation (AF) based on the pivotal ROCKET AF trial, which demonstrated its noninferiority to warfarin with a reduced risk of intracranial hemorrhage.³ In 2012 the label was expanded to include the treatment and secondary prevention of DVT and pulmonary embolism (PE) following the EINSTEIN-DVT and EINSTEIN-PE trials.³

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.³ 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).³

Currently the 10 mg, 15, mg, and 20 mg generic tablets from Lupin and Taro have tentative approval from the FDA. More than a dozen other generics companies are vying for approval of their rivaroxaban formulations.²

References
1. FDA roundup: march 4, 2025. News release. US Food and Drug Administration. March 4, 2025. Accessed March 5, 2025. https://www.fda.gov/news-events/press-announcements/fda-roundup-march-4-2025
2. Lou N. First generics for low-dose rivaroxaban get FDA approval. Medpage Today. March 5, 2025. https://www.medpagetoday.com/cardiology/prevention/114501
3. Stewart J. Xarelto FDA approval history. Drugs.com. Last updated December 26, 2021. https://www.drugs.com/history/xarelto.html
4. Eikelboom JW, Connolly SJ, Bosch, J et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377(14):1319-1330.