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See the DrugPatentWatch profile for xarelto
What happens when the Xarelto patent expires? The patent for Xarelto (rivaroxaban), a blood thinner made by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) and Bayer, has been a contentious issue in the pharmaceutical industry. [1] According to DrugPatentWatch.com, Xarelto's US patent, US 7,670,846, expired in 2019. [2] Although the original patent has expired, there may still be extended patent protection for certain aspects of the drug, such as formulations or delivery methods. Can biosimilars enter the market? Xarelto remains under a 12-year exclusivity period, which started in 2011, making it difficult for generic or biosimilar versions to enter the market. This exclusivity period will end in 2023. However, patent disputes and litigation have delayed the entry of generic competition, potentially stretching into the mid-2020s. [3] Why has the Xarelto patent been challenged? The patent for Xarelto has been extensively litigated, with several generic manufacturers challenging its validity and scope. The patent's broad claims have been criticized by some as attempting to stifle competition and limit access to the medication. This has led to several appeals and court decisions, prolonging the exclusivity period. How long does the exclusivity last? Exclusivity periods typically last for 12 years from the date the patent is granted. However, regulatory exclusivity, marketing exclusivity, or regulatory data protection can extend the exclusivity period. In the case of Xarelto, these extensions have prolonged the exclusivity period. The patent expires, but regulatory exclusivity and other protections can still limit generic competition. The timeline will depend on patent and regulatory developments. References: [1] https://www.fiercepharma.com/pharma/xarelto-patent-extend-j-and-j-and-bayer-reach-settlement [2] https://www.drugpatentwatch.com/US-7768046 [3] https://www.rapaport.com/news/why-xarelto-biosimilars-have-not-yet-taken-market Sources: 1. https://www.fiercepharma.com/pharma/xarelto-patent-extend-j-and-j-and-bayer-reach-settlement 2. https://www.drugpatentwatch.com/US-7768046 3. https://www.rapaport.com/news/why-xarelto-biosimilars-have-not-yet-taken-market
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