Skip to main content

Generic Xarelto Availability

Last updated on Sep 8, 2022.

Xarelto is a brand name of rivaroxaban, approved by the FDA in the following formulation(s):

XARELTO (rivaroxaban - for suspension;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: December 20, 2021
    Strength(s): 1MG/ML [RLD]

XARELTO (rivaroxaban - tablet;oral)

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.

  • Patent 10,828,310

    Patent expiration dates:

    • January 31, 2039
      ✓ 
      Patent use: REDUCTION OF RISK OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH CAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY
    • January 31, 2039
      ✓ 
      Patent use: REDUCTION OF RISK OF MYOCARDIAL INFARCTION AND ISCHEMIC STROKE IN PATIENTS WITH PAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY
  • Patent 10828310*

    Patent expiration dates:

    • July 31, 2039
  • Substituted oxazolidinones and their use in the field of blood coagulation
    Patent 7,157,456
    Issued: January 2, 2007
    Inventor(s): Straub; Alexander & Lampe; Thomas & Pohlmann; Jens & Röhrig; Susanne & Perzborn; Elisabeth & Schlemmer; Karl-Heinz & Pernerstorfer; Joseph
    Assignee(s): Bayer HealthCare AG

    The invention relates to the field of blood coagulation. Novel oxazolidinone derivatives of the general formula (I) processes for their preparation and their use as medicinally active compounds for the prophylaxis and/or treatment of disorders are described.

    Patent expiration dates:

    • August 28, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 28, 2024
      ✓ 
      Patent use: TREATMENT OF PULMONARY EMBOLISM (PE)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 28, 2024
      ✓ 
      Patent use: TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 28, 2025
      ✓ 
      Pediatric exclusivity
  • Solid, orally administrable pharmaceutical composition
    Patent 9,415,053
    Issued: August 16, 2016
    Assignee(s): Bayer Intellectual Property GmbH

    The 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
      ✓ 
      Patent use: REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CV DEATH, MI, AND STROKE) IN CHRONIC CAD OR PAD
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION AND STROKE) IN PATIENTS WITH CAD
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: REDUCTION OF RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF THROMBOEMBOLIC DISEASES IN PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE WHO HAVE UNDERGONE THE FONTAN PROCEDURE AND A BODY WEIGHT OF >=50 KG
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR RECURRENT DVT AND/OR AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: TREATMENT OF PULMONARY EMBOLISM (PE)
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF 30 KG TO 49.9 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
      ✓ 
      Drug product
    • November 13, 2024
      ✓ 
      Patent use: TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF >=50 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT
      ✓ 
      Drug product
    • May 13, 2025
      ✓ 
      Pediatric exclusivity
  • Prevention and treatment of thromboembolic disorders
    Patent 9,539,218
    Issued: January 10, 2017
    Assignee(s): BAYER INTELLECTUAL PROPERTY GMBH

    The 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
      ✓ 
      Patent use: PROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM IN PATIENTS UNDERGOING KNEE OR HIP REPLACEMENT SURGERY, WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS, TO REDUCE THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS AND/OR PULMONARY EMBOLISM IN CERTAIN PATIENTS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: PROPHYLAXIS OF PE, DVT AND/OR STROKE IN PEDIATRIC PATIENTS (>=50 KG) AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE AFTER FONTAN PROCEDURE WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: REDUCE THE RISK OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: TREATMENT OF DVT AND/OR PE AND REDUCTION IN RISK OF RECURRENT DVT AND/OR PE IN PEDIATRIC PATIENTS (30-49.9 KG) ONCE DAILY WITH RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS AFTER AT LEAST 5 DAYS PARENTERAL ANTICOAGULANT TREATMENT
    • February 17, 2034
      ✓ 
      Patent use: TREATMENT OF PULMONARY EMBOLISM WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: TREATMENT OF DEEP VEIN THROMBOSIS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
    • February 17, 2034
      ✓ 
      Patent use: TREATMENT OF DVT AND/OR PE AND REDUCTION IN THE RISK OF RECURRENT DVT AND/OR PE IN PEDIATRIC PATIENTS (>=50 KG) ONCE DAILY WITH RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS AFTER AT LEAST 5 DAYS PARENTERAL ANTICOAGULANT TREATMENT
    • August 17, 2034
      ✓ 
      Pediatric exclusivity

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:

    • October 11, 2022 - PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
    • April 11, 2023 - PEDIATRIC EXCLUSIVITY
    • 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

Glossary

Term Definition
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.