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When Will Xarelto Be Available as a Generic? Xarelto (rivaroxaban) is a popular anticoagulant used to prevent stroke and blood clots in patients with non-valvular atrial fibrillation, as well as to treat deep vein thrombosis and pulmonary embolism. As of 2022, Xarelto is still under patent protection held by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1]. According to the FDA's Orange Book, the patent for Xarelto in the US is expected to expire on [May 5, 2029][2]. Who Will Be Manufacturing a Generic Version? As the patent expiration approaches, several generic manufacturers have initiated the FDA approval process to bring a generic version of Xarelto to market. Some of the companies that have announced plans to launch a generic Xarelto include: * Mylan (now part of Upjohn) * Teva Pharmaceuticals * Dr. Reddy's Laboratories [3] * Sandoz Pharmaceuticals (now part of Novartis) * Hetero Drugs [4] Can Biosimilars Enter Before Patent Expiry? The approval process for biosimilars (similar to biologics) can take several years, and companies must provide extensive data demonstrating the equivalence of their biosimilar to the originator product. However, there are ongoing discussions and debates within the industry regarding the possibility of biosimilars entering the market before the patent expires. According to a report by R&D News, biosimilars could gain a competitive advantage if they are launched before the patent expires, as they may attract more price-sensitive patients seeking cheaper alternatives [5]. How Long After Patent Expiry Will Generic Xarelto Be Available? The availability of generic Xarelto after the patent expires will depend on several factors, including regulatory approval and the ability of manufacturers to scale up production. Typically, generic versions become available within a few months after the patent expires. As the patent expires in 2029, it is expected that generic Xarelto will become available to patients in early 2029 or even later, pending FDA approval of the generic manufacturer. References: [1] DrugPatentWatch.com [2] FDA Orange Book [3] Dr. Reddy's Laboratories press release [4] Hetero Drugs press release [5] R&D News report
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