Earlier this month, the FDA approved the first generic versions of Xarelto (rivaroxaban). The FDA’s approval specifically covers generic rivaroxaban 2.5 mg tablets for:
- Reducing the risk of major cardiovascular events in adult patients with coronary artery disease (CAD)
- Reducing the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone lower extremity revascularization procedures
Anticoagulants like Xarelto are among the most frequently prescribed medications in the United States, and this new generic option aims to expand treatment options while reducing costs.
When May Xarelto be Used in Workers’ Compensation Claims?
While anticoagulants aren’t typically prescribed for work-related injuries, and the release of a generic formulation will have minimal impact on workers’ compensation programs, Xarelto may be prescribed in workers’ compensation claims under specific circumstances:
- For workers with traumatic injuries requiring extended immobilization who are at risk for deep vein thrombosis (DVT)
- In cases involving cardiovascular complications following workplace injuries
- For injured workers with pre-existing CAD or PAD whose conditions must be managed alongside their work-related injuries
- Post-surgical prophylaxis following work-related surgeries to prevent blood clots
Broader Industry Impact
The FDA’s authorization of generic rivaroxaban supports broader initiatives to increase affordable medication access. Xarelto was identified for the initial phase of negotiations under the 2022 Inflation Reduction Act, which empowers Medicare to negotiate prices for select prescription medications. However, the emergence of a generic Xarelto alternative will diminish the anticipated savings from these negotiated prices, as the lower-cost generic options will largely offset these potential benefits.
Looking Ahead
While the initial approval covers only the 2.5 mg dosage form focused on CAD and PAD indications, this development suggests potential future approvals for other dosage forms and indications. Xarelto is also available as an oral suspension and in 10 mg, 15 mg and 20 mg tablets.