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Generic Otrexup Availability

Last updated on Oct 6, 2021.

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

OTREXUP (methotrexate - solution;subcutaneous)

  • Manufacturer: ANTARES PHARMA INC
    Approval date: October 11, 2013
    Strength(s): 10MG/0.4ML (10MG/0.4ML) [RLD], 15MG/0.4ML (15MG/0.4ML) [RLD], 20MG/0.4ML (20MG/0.4ML) [RLD], 25MG/0.4ML (25MG/0.4ML) [RLD]
  • Manufacturer: ANTARES PHARMA INC
    Approval date: November 7, 2014
    Strength(s): 7.5MG/0.4ML (7.5MG/0.4ML) (discontinued) [RLD]
  • Manufacturer: ANTARES PHARMA INC
    Approval date: March 24, 2016
    Strength(s): 12.5MG/0.4ML (12.5MG/0.4ML) [RLD], 17.5MG/0.4ML (17.5MG/0.4ML) [RLD], 22.5MG/0.4ML (22.5MG/0.4ML) [RLD]

Has a generic version of Otrexup been approved?

No. There is currently no therapeutically equivalent version of Otrexup available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Otrexup. 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 10,709,844

    Patent expiration dates:

    • March 10, 2029
      ✓ 
      Drug product
  • Prefilled syringe jet injector
    Patent 8,021,335
    Issued: September 20, 2011
    Inventor(s): Lesch, Jr.; Paul R.
    Assignee(s): Antares Pharma, Inc.

    A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

    Patent expiration dates:

    • October 4, 2026
      ✓ 
      Drug product
  • Hazardous agent injection system
    Patent 8,480,631
    Issued: July 9, 2013
    Assignee(s): Antares Pharma, Inc.

    A hazardous agent injection system including from about 0.02 ml to about 4.0 ml of methotrexate at a concentration of from about 7.5 mg/ml to about 150 mg/ml; a needle-assisted jet injector including a container configured to contain the methotrexate; a injection outlet member associated with the container; an injection-assisting needle coupled to the injection outlet member; a firing mechanism associated with the container; an energy source associated with the firing mechanism; and a trigger mechanism associated with the firing mechanism, wherein the needle-assisted jet injector is configured to eject the methotrexate from the injection outlet member such that the Cmax, Tmax and bioavailability of the needle-assisted jet injected methotrexate falls between about 80% and about 125% of the Cmax, Tmax and bioavailability of methotrexate delivered by a hand-powered syringe.

    Patent expiration dates:

    • March 19, 2030
      ✓ 
      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
      ✓ 
      Drug product
  • Prefilled syringe jet injector
    Patent 8,562,564
    Issued: October 22, 2013
    Assignee(s): Antares Pharma, Inc.

    A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

    Patent expiration dates:

    • January 24, 2026
      ✓ 
      Drug product
  • Hazardous agent injection system
    Patent 8,579,865
    Issued: November 12, 2013
    Assignee(s): Antares Pharma, Inc.

    Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

    Patent expiration dates:

    • March 19, 2030
      ✓ 
      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
      ✓ 
      Drug product
  • Injector safety device
    Patent 8,814,834
    Issued: August 26, 2014
    Assignee(s): Antares Pharma, Inc.

    A safety member for use with an injection device is disclosed. The safety member includes a blocking ring extending into a housing of the injection device in blocking association with a latch member associated with a trigger mechanism of the injector, in which the blocking ring blocks movement of a portion of the trigger mechanism into a firing position. The safety member further includes a manipulable portion disposed outside the housing and configured for hand-manipulation by a user to remove the safety member from the housing to unblock the firing mechanism to enable firing of the injector.

    Patent expiration dates:

    • May 27, 2031
      ✓ 
      Drug product
  • Hazardous agent injection system
    Patent 8,945,063
    Issued: February 3, 2015
    Assignee(s): Antares Pharma, Inc.

    Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

    Patent expiration dates:

    • March 19, 2030
      ✓ 
      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
      ✓ 
      Drug product
  • Hazardous agent injection system
    Patent 9,421,333
    Issued: August 23, 2016
    Assignee(s): Antares Pharma, Inc.

    Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

    Patent expiration dates:

    • March 19, 2030
      ✓ 
      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
      ✓ 
      Drug product
  • Prefilled syringe jet injector
    Patent 9,533,102
    Issued: January 3, 2017
    Assignee(s): Antares Pharma, Inc.

    A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

    Patent expiration dates:

    • January 24, 2026
      ✓ 
      Drug product
  • Prefilled syringe jet injector
    Patent 9,629,959
    Issued: April 25, 2017
    Assignee(s): Antares Pharma, Inc.

    A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

    Patent expiration dates:

    • January 24, 2026
      ✓ 
      Drug product
  • Injector safety device
    Patent 9,867,949
    Issued: January 16, 2018
    Assignee(s): Antares Pharma, Inc.

    A safety member for use with an injection device is disclosed. The safety member includes a blocking ring extending into a housing of the injection device in blocking association with a latch member associated with a trigger mechanism of the injector, in which the blocking ring blocks movement of a portion of the trigger mechanism into a firing position. The safety member further includes a manipulable portion disposed outside the housing and configured for hand-manipulation by a user to remove the safety member from the housing to unblock the firing mechanism to enable firing of the injector.

    Patent expiration dates:

    • March 10, 2029
      ✓ 
      Drug product

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.