{"id":631543,"date":"2025-03-07T11:23:06","date_gmt":"2025-03-07T16:23:06","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=631543"},"modified":"2025-10-16T14:53:04","modified_gmt":"2025-10-16T18:53:04","slug":"fda-approves-generic-xarelto","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-generic-xarelto\/","title":{"rendered":"FDA approves generic Xarelto"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On March 4, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of the first generic form of <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/xarelto\"><span style=\"font-weight: 400;\">Xarelto<\/span><\/a><span style=\"font-weight: 400;\"> (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 <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/xarelto-without-insurance\/\"><span style=\"font-weight: 400;\">average cost of over $600<\/span><\/a><span style=\"font-weight: 400;\"> for a monthly supply without insurance. This approval should help reduce the prices of this essential medication.<\/span><\/p>\n<h2 id=\"what-is-xarelto-generic\"><span style=\"font-weight: 400;\">What is Xarelto generic?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Rivaroxaban is a medication that contains the same active ingredient and provides the same benefits as <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/xarelto\"><span style=\"font-weight: 400;\">Xarelto<\/span><\/a><span style=\"font-weight: 400;\">, a newer type of blood thinner.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">You may be familiar with traditional anticoagulants, or blood thinners, such as <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/warfarin-sodium\"><span style=\"font-weight: 400;\">Coumadin (warfarin<\/span><\/a><span style=\"font-weight: 400;\">) and heparin\u2014prescriptions that have been in use for many decades. Manufactured by Janssen Pharmaceuticals, Xarelto (rivaroxaban) belongs to a newer class of anticoagulants called <\/span><a href=\"https:\/\/www.heart.org\/-\/media\/files\/health-topics\/answers-by-heart\/what-are-doacs.pdf\"><span style=\"font-weight: 400;\">direct-acting oral anticoagulants <\/span><\/a><span style=\"font-weight: 400;\">(DOAC). Other medications that belong to this category include <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/pradaxa\"><span style=\"font-weight: 400;\">Pradaxa (dabigatran<\/span><\/a><span style=\"font-weight: 400;\">), <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/eliquis\"><span style=\"font-weight: 400;\">Eliquis (apixaban)<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/savaysa\"><span style=\"font-weight: 400;\">Savaysa (edoxaban<\/span><\/a><span style=\"font-weight: 400;\">). Unlike warfarin, they don\u2019t 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.<\/span><\/p>\n<p><a href=\"https:\/\/medlineplus.gov\/druginfo\/meds\/a611049.html#why\"><span style=\"font-weight: 400;\">Rivaroxaban<\/span><\/a><span style=\"font-weight: 400;\"> 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).\u00a0<\/span><\/p>\n<h2 id=\"how-does-the-xarelto-generic-compare-to-the-brand-name\"><span style=\"font-weight: 400;\">How does the Xarelto generic compare to the brand name?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">To <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/frequently-asked-questions-popular-topics\/generic-drugs-questions-answers\"><span style=\"font-weight: 400;\">gain FDA approval<\/span><\/a><span style=\"font-weight: 400;\">, 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. <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/generic-drugs\/generic-drug-facts\"><span style=\"font-weight: 400;\">Generics<\/span><\/a><span style=\"font-weight: 400;\"> can look different from the brand-name version, however, in pill size, shape, or color.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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 <\/span><a href=\"https:\/\/www.singlecare.com\/drug-classes\/anticoagulants\"><span style=\"font-weight: 400;\">other options<\/span><\/a><span style=\"font-weight: 400;\">, so you can talk to your healthcare team about which might be most appropriate for you.<\/span><\/p>\n<h2 id=\"why-this-approval-is-important\"><span style=\"font-weight: 400;\">Why this approval is important<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">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.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-drug-treat-help-prevent-types-blood-clots-certain-pediatric-populations\"><span style=\"font-weight: 400;\">FDA originally approved Xarelto in tablet form in 2011<\/span><\/a><span style=\"font-weight: 400;\"> 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.<\/span><\/p>\n<h2 id=\"how-much-will-generic-xarelto-cost\"><span style=\"font-weight: 400;\">How much will generic Xarelto cost?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Although a Xarelto generic price hasn\u2019t been established yet, generics typically cost less than their brand-name counterparts.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The FDA <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/generic-drugs\/generic-drug-facts\"><span style=\"font-weight: 400;\">reports <\/span><\/a><span style=\"font-weight: 400;\">that one generic competitor can reduce the cost by 30%, and five generic competitors could reduce the cost by as much as 85%.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.singlecare.com\/prescription\/xarelto\/dosage\"><span style=\"font-weight: 400;\">Xarelto dosing<\/span><\/a><span style=\"font-weight: 400;\"> varies by indication. With a SingleCare <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/xarelto\"><span style=\"font-weight: 400;\">coupon<\/span><\/a><span style=\"font-weight: 400;\">, you could pay as little as $247 for a 30-day supply of 2.5 mg <a href=\"https:\/\/www.singlecare.com\/prescription\/xarelto\/dosage\">Xarelto tablets<\/a>, depending on your location and choice of pharmacy. You\u2019ll likely pay less for rivaroxaban generic tablets once they\u2019re available.\u00a0<\/span><\/p>\n<h2 id=\"when-will-generic-xarelto-be-available\"><span style=\"font-weight: 400;\">When will generic Xarelto be available?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">It\u2019s 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.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":631544,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[9650,4141,737],"coauthors":[9482],"class_list":["post-631543","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-blood-thinners","tag-fda-approvals","tag-heart-health","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves first generic Xarelto<\/title>\n<meta name=\"description\" content=\"The FDA approved the first generic version of rivaroxaban 2.5 mg tablets to reduce the 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