FDA Approves First Generic of Rivaroxaban (Xarelto) for CAD, PAD

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the first generic formulation of rivaroxaban (Xarelto) 2.5 mg tablets to lower cardiovascular risk in adults with coronary artery disease (CAD) and thrombotic risk in adults with peripheral artery disease (PAD).¹

As announced by the FDA on March 4, 2025, anticoagulants, including rivaroxaban, are commonly prescribed in the US, with the agency citing the approval of the first generics of rivaroxaban, 2.5 mg, tablets as directly impacting patients who rely on these medications.

“Approving safe and effective generics to help provide patients more treatment options continues to be a priority for the FDA,” the agency wrote.

Both CAD and PAD are notable public health concerns and stem from atherosclerosis, a buildup of plaque in the arteries that restricts blood flow, leading to symptoms like chest pain in CAD and leg pain in PAD. Potential complications of these conditions include heart attacks and limb loss, respectively. Oral rivaroxaban is widely prescribed in the US to prevent and treat thromboembolic conditions.²

As a leading cause of mortality and morbidity worldwide, atherothrombotic disease can create a substantial medical and economic burden on society. Although most evidence on the burden of atherosclerotic disease comes from high-income countries, the burden of atherosclerotic CV disease is increasing in low- and middle-income countries.²

Awarded to Taro Pharmaceuticals Industries, this generic approval is targeted to reduce the risk of major cardiovascular events in adult patients with CAD and the risk of major thrombotic vascular events in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.³

The FDA initially approved rivaroxaban to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction, and stroke in people with chronic CAD or PAD in October 2018, becoming the first and only Factor Xa inhibitor approved for patients living with these conditions.⁴

Results from the COMPASS trial showed a combination of low-dose rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily) significantly reduced (–24%) the risk of major cardiovascular events in patients with chronic CAD and PAD. Other findings from the VOYAGER-PAD trial found that this combination therapy lowered the incidence of major adverse limb and cardiovascular events in PAD patients who had undergone lower-extremity revascularization.⁵

References

1. Commissioner O of the. FDA roundup: March 4, 2025. U.S. 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. Bauersachs R, Zeymer U, Brière JB, Marre C, Bowrin K, Huelsebeck M. Burden of Coronary Artery Disease and Peripheral Artery Disease: A Literature Review. Cardiovasc Ther. 2019;2019:8295054. Published 2019 Nov 26. doi:10.1155/2019/8295054

3. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. March 3, 2025. Accessed March 5, 2025. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=208557#239.

4. U.S. FDA approves Xarelto® (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). JNJ.com. October 11, 2018. Accessed March 5, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-xarelto-rivaroxaban-to-reduce-the-risk-of-major-cardiovascular-events-in-patients-with-chronic-coronary-artery-disease-cad-or-peripheral-artery-disease-pad

5. Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020;382(21):1994-2004. doi:10.1056/NEJMoa2000052