Generic Xarelto Availability
Last updated on Jun 12, 2024.
Xarelto is a brand name of rivaroxaban, approved by the FDA in the following formulation(s):
XARELTO (rivaroxaban - for suspension;oral)
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Manufacturer: JANSSEN PHARMS
Approval date: December 20, 2021
Strength(s): 1MG/ML [RLD]
XARELTO (rivaroxaban - tablet;oral)
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Manufacturer: JANSSEN PHARMS
Approval date: July 1, 2011
Strength(s): 10MG [RLD] -
Manufacturer: JANSSEN PHARMS
Approval date: November 4, 2011
Strength(s): 15MG [RLD], 20MG [RLD] -
Manufacturer: JANSSEN PHARMS
Approval date: October 11, 2018
Strength(s): 2.5MG [RLD]
Has a generic version of Xarelto been approved?
No. There is currently no therapeutically equivalent version of Xarelto available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xarelto. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Reducing the risk of cardiovascular events
Patent 10,828,310
Issued: November 10, 2020
Inventor(s): Bruns Nancy Cook & Misselwitz Frank & Eikelboom John William Andrew & Connolly Stuart J. & Yusuf Salim
Assignee(s): BAYER PHARMA AKTIENGESELLSCHAFTCombination therapy with rivaroxaban and aspirin successfully reduces the risk of cardiovascular events in patients who have coronary artery disease and/or peripheral artery disease.
Patent expiration dates:
- January 31, 2039✓
- January 31, 2039✓
- January 31, 2039
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Reducing the risk of cardiovascular events
Patent 10828310*PE
Issued: November 10, 2020
Inventor(s): Bruns Nancy Cook & Misselwitz Frank & Eikelboom John William Andrew & Connolly Stuart J. & Yusuf Salim
Assignee(s): BAYER PHARMA AKTIENGESELLSCHAFTCombination therapy with rivaroxaban and aspirin successfully reduces the risk of cardiovascular events in patients who have coronary artery disease and/or peripheral artery disease.
Patent expiration dates:
- July 31, 2039
- July 31, 2039
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Patent 7,157,456
Patent expiration dates:
- August 28, 2024✓✓
- August 28, 2024✓✓✓
- August 28, 2024✓✓✓
- August 28, 2024
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Patent 7157456*PED
Patent expiration dates:
- February 28, 2025✓
- February 28, 2025
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Solid, orally administrable pharmaceutical composition
Patent 9,415,053
Issued: August 16, 2016
Inventor(s): Benke Klaus
Assignee(s): Bayer Intellectual Property GmbHThe present invention relates to a process for the preparation of a solid, orally administrable pharmaceutical composition, comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form, and its use for the prophylaxis and/or treatment of diseases.
Patent expiration dates:
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024✓✓
- November 13, 2024
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Solid, orally administrable pharmaceutical composition
Patent 9415053*PED
Issued: August 16, 2016
Inventor(s): Benke Klaus
Assignee(s): Bayer Intellectual Property GmbHThe present invention relates to a process for the preparation of a solid, orally administrable pharmaceutical composition, comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form, and its use for the prophylaxis and/or treatment of diseases.
Patent expiration dates:
- May 13, 2025✓
- May 13, 2025
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Prevention and treatment of thromboembolic disorders
Patent 9,539,218
Issued: January 10, 2017
Inventor(s): Misselwitz Frank & Kubitza Dagmar & Park Son-Mi & Wehling Klaus
Assignee(s): BAYER INTELLECTUAL PROPERTY GMBHThe present invention relates to the field of blood coagulation, more specifically it relates to a method of treating a thromboembolic disorder by administering once daily a direct factor Xa inhibitor in oral dosage form to a patient in need thereof, wherein the factor Xa inhibitor has a plasma concentration half life indicative of a bid or tid administration interval, e.g. of 10 hours or less.
Patent expiration dates:
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034✓
- February 17, 2034
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Prevention and treatment of thromboembolic disorders
Patent 9539218*PED
Issued: January 10, 2017
Inventor(s): Misselwitz Frank & Kubitza Dagmar & Park Son-Mi & Wehling Klaus
Assignee(s): BAYER INTELLECTUAL PROPERTY GMBHThe present invention relates to the field of blood coagulation, more specifically it relates to a method of treating a thromboembolic disorder by administering once daily a direct factor Xa inhibitor in oral dosage form to a patient in need thereof, wherein the factor Xa inhibitor has a plasma concentration half life indicative of a bid or tid administration interval, e.g. of 10 hours or less.
Patent expiration dates:
- August 17, 2034✓
- August 17, 2034
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- August 23, 2024 - INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMIT
- December 20, 2024 - NEW PRODUCT
- February 23, 2025 - PEDIATRIC EXCLUSIVITY
- June 20, 2025 - PEDIATRIC EXCLUSIVITY
More about Xarelto (rivaroxaban)
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- Drug class: factor Xa inhibitors
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.