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FDA approves generic Xarelto

There’s a new—hopefully, lower cost—option for people who take anticoagulants to manage heart disease
Jennifer Larson writer headshot
By | Mar. 7, 2025 Medically reviewed by Karen Berger, Pharm.D.
FDA approves generic Xarelto

Key takeaways

  • The FDA approved the first generic of the popular anticoagulant medication Xarelto (rivaroxaban).

  • The approval is for 2.5 mg tablets to help reduce the risk of major cardiovascular events in adults with coronary artery disease and reduce the risk of major thrombotic vascular events in adults with peripheral artery disease. Other dosage strengths have not yet been approved as generic.

  • The exact cost and availability date of the generic version of Xarelto have not yet been released.

In this article:

On March 4, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of the first generic form of Xarelto (rivaroxaban), a popular anticoagulant medication. The approval is for the 2.5 mg tablets prescribed to reduce the risk of major cardiovascular events in adults with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adults with peripheral artery disease (PAD). Anticoagulants are some of the most commonly prescribed medications in the United States, and Xarelto is an expensive prescription with an average cost of over $600 for a monthly supply without insurance. This approval should help reduce the prices of this essential medication.

What is Xarelto generic?

Rivaroxaban is a medication that contains the same active ingredient and provides the same benefits as Xarelto, a newer type of blood thinner.

You may be familiar with traditional anticoagulants, or blood thinners, such as Coumadin (warfarin) and heparin—prescriptions that have been in use for many decades. Manufactured by Janssen Pharmaceuticals, Xarelto (rivaroxaban) belongs to a newer class of anticoagulants called direct-acting oral anticoagulants (DOAC). Other medications that belong to this category include Pradaxa (dabigatran), Eliquis (apixaban), and Savaysa (edoxaban). Unlike warfarin, they don’t stop the action of vitamin K to reduce blood clotting. They instead inhibit one of the important steps in the clotting process. Because of the way DOACs work, they require less frequent blood monitoring and dietary restrictions compared to older anticoagulants like warfarin.

Rivaroxaban is often prescribed to prevent and treat blood clots in the leg, a condition known as deep vein thrombosis (DVT), or blood clots in the lungs, a condition known as pulmonary embolism (PE). 

How does the Xarelto generic compare to the brand name?

To gain FDA approval, a generic medication must be proven to work the same and provide the same benefits as the brand-name medication. That means you should have the same treatment experience taking rivaroxaban as Xarelto. Generics can look different from the brand-name version, however, in pill size, shape, or color.

Since the medications share the same active ingredient, you would not want to take the generic version if you have experienced major side effects, a drug interaction, an allergic reaction, or any other problems when taking Xarelto. There are a number of other options, so you can talk to your healthcare team about which might be most appropriate for you.

Why this approval is important

The approval of the generic form of Xarelto means that people who can benefit from this medication will now have the option to purchase it at a lower price point. It could improve their access to a medication that could save their life. 

The FDA originally approved Xarelto in tablet form in 2011 and later approved it as an oral suspension in 2021. While the oral suspension version of Xarelto can be used in children, the newly approved generic version of rivaroxaban, which is available only in tablet form, is only indicated for use in adults.

How much will generic Xarelto cost?

Although a Xarelto generic price hasn’t been established yet, generics typically cost less than their brand-name counterparts. 

The FDA reports that one generic competitor can reduce the cost by 30%, and five generic competitors could reduce the cost by as much as 85%. 

Xarelto dosing varies by indication. With a SingleCare coupon, you could pay as little as $247 for a 30-day supply of 2.5 mg Xarelto tablets, depending on your location and choice of pharmacy. You’ll likely pay less for rivaroxaban generic tablets once they’re available. 

When will generic Xarelto be available?

It’s unknown when the generic version of Xarelto will be available. Only 2.5 mg tablets will be available in generic form, and other doses are only available in the brand-name version.