Generic Xarelto Availability

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

XARELTO (rivaroxaban - tablet;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: July 1, 2011
    Strength(s): 10MG [RLD]
  • Manufacturer: JANSSEN PHARMS
    Approval date: November 4, 2011
    Strength(s): 15MG, 20MG [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: About generic drugs.

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.

  • 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:
    • February 8, 2021
      ✓ 
      Patent use: TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 8, 2021
      ✓ 
      Patent use: TREATMENT OF PULMONARY EMBOLISM (PE)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Substituted oxazolidinones and their use in the field of blood coagulation
    Patent 7,585,860
    Issued: September 8, 2009
    Inventor(s): Straub; Alexander & Lampe; Thomas & Pohlmann; Jens & Rohrig; Susanne & Perzborn; Elisabeth & Schlemmer; Karl-Heinz & Pernerstorfer; Joseph
    Assignee(s): Bayer Schering Pharma Aktiengesellschaft
    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:
    • December 11, 2020
      ✓ 
      Patent use: REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM
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      Drug substance
  • Substituted oxazolidinones and their use in the field of blood coagulation
    Patent 7,592,339
    Issued: September 22, 2009
    Inventor(s): Straub; Alexander & Lampe; Thomas & Pohlmann; Jens & Rohrig; Susanne & Perzborn; Elisabeth & Schlemmer; Karl-Heinz & Pernerstorfer; Joseph
    Assignee(s): Bayer Schering Pharma Aktiengesellschaft
    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:
    • December 11, 2020
      ✓ 
      Patent use: REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM
    • December 11, 2020
      ✓ 
      Patent use: TREATMENT OF PULMONARY EMBOLISM (PE)
    • December 11, 2020
      ✓ 
      Patent use: REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
    • December 11, 2020
      ✓ 
      Patent use: TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
    • December 11, 2020
      ✓ 
      Patent use: PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)

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:
    • November 4, 2014 - REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION.
    • November 2, 2015 - REDUCTION IN RISK FOR DEEP VEIN THROMBOSIS AND THE REDUCTION IN RISK FOR PULMONARY EMBOLISM
    • November 2, 2015 - TREATMENT OF DEEP VEIN THROMBOSIS
    • November 2, 2015 - TREATMENT OF PULMONARY EMBOLISM
    • July 1, 2016 -

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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