FDA Approves First Generics of Xarelto

The FDA has approved the first generics of Xarelto (rivaroxaban) 2.5 mg tablets, an anticoagulant to prevent deep vein thrombosis in adults with peripheral artery disease and to reduce the risk of major cardiovascular events adults with coronary artery disease.

Anticoagulants such Xarelto are among the most commonly prescribed medications in the United States and are used to prevent blood clots. In coronary artery disease, there reduced blood flow to the heart muscle caused by a buildup of fats, cholesterol and other substances in and on the artery walls. Coronary artery disease accounts for approximately 610,000 deaths annually (estimated 1 in 4 deaths) and is the leading cause of mortality in the United States, according to StatPearls.

Peripheral artery disease is a common condition in which narrowed arteries reduce blood to the arms and legs. The prevalence of peripheral artery disease increases with age, and about one in every 20 Americans over the age of 50 has peripheral artery disease, according to the National Institutes of Health. It affects 8 to 12 million people in the United States.

Two generic manufacturers — Lupin and Taro Pharmaceuticals — have received approval for their generic versions of the 2.5 mg table. A press release from Lupin indicates its version has already launched.

Xarelto’s product site claims it has been prescribed more than 80 million times in the United States alone. Developed and marketed by Johnson & Johnson and Bayer, Xarelto is also approved as a 10 mg, 15 mg and 20 mg tables, and as an oral suspension. A Johnson & Johnson spokesperson said the company will continue to market all strengths of Xarelto tablets and oral suspensions and the company will continue to vigorously defend its intellectual property rights.

Xarelto has a price of about $633.62 for 60 of the 2.5mg tablets, according to Drugs.com. A savings card allows commercially insured patients to receive Xarelto for as little as $10 for each fill. But the product website indicates that Johnson & Johnson may reduce the maximum benefit for patients in an accumulator or maximizer program or benefit design. J&J also offers a free 30-day supply.

Generic drugs generally launch at about a discount of 40% to 60% of the branded price.

Related: HHS Releases Prices for Medicare Negotiated Drugs

Xarelto, along with Eliquis and Jardiance, was among the highest Medicare spending, between June 1, 2022, and May 31, 2023. Xarelto was part of the first list of drugs to be negotiated through the drug price negotiation program under the Inflation Reduction Act (IRA) of 2022. CMS negotiated a price of $197, which is 62% less than the list prices for a 30 day supply in 2023. The new price goes into effect in January 2026. Medicare part D prescriptions for Xarelto totaled 1,324,000 in 2023 with total part D gross costs of $6.3 billion that year.

Rivaroxaban contains a boxed warning about an increased risk of thrombotic events, which occur when blood clots form inside a blood vessel, or strokes if a patient stops using rivaroxaban too early.