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Generic Otrexup Availability

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), 15MG/0.4ML (15MG/0.4ML), 20MG/0.4ML (20MG/0.4ML), 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)
  • Manufacturer: ANTARES PHARMA INC
    Approval date: March 24, 2016
    Strength(s): 12.5MG/0.4ML (12.5MG/0.4ML), 17.5MG/0.4ML (17.5MG/0.4ML), 22.5MG/0.4ML (22.5MG/0.4ML)

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: 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.

  • Needle assisted jet injector
    Patent 6,746,429
    Issued: June 8, 2004
    Inventor(s): Peter L.; Sadowski & David M.; DeBoer & Claude L.; Berman & Paul R.; Lesch, Jr. & Margaret L.; Holland
    Assignee(s): Antares Pharma, Inc.
    A needle assisted jet injector and method for jet injecting medicament are disclosed. In one embodiment of the injector, the needle is retractably located within an injector nozzle assembly. Upon activation of the force generating source, a portion of the needle extends past the nozzle assembly and penetrates the outer layer of skin to deliver the medicament via jet injection to a deeper region. After activation, the needle retracts back into the nozzle assembly. In another embodiment, the needle is fixed to the end of the nozzle assembly. In both embodiments, the length of the portion of the needle that penetrates the skin is less than 5 mm.
    Patent expiration dates:
    • April 12, 2020
      ✓ 
      Drug product
  • Needle assisted jet injector
    Patent 7,744,582
    Issued: June 29, 2010
    Inventor(s): Sadowski; Peter L. & Deboer; David M. & Berman; Claude L. & Lesch, Jr.; Paul R. & Holland; Margaret L.
    Assignee(s): Antares Pharma, Inc.
    A needle assisted jet injector and method for jet injecting medicament are disclosed. In one embodiment of the injector, the needle is retractably located within an injector nozzle assembly. Upon activation of the force generating source, a portion of the needle extends past the nozzle assembly and penetrates the outer layer of skin to deliver the medicament via jet injection to a deeper region. After activation, the needle retracts back into the nozzle assembly. In another embodiment, the needle is fixed to the end of the nozzle assembly. In both embodiments, the length of the portion of the needle that penetrates the skin is less than 5 mm.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
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      Drug product
  • Needle assisted jet injector
    Patent 7,776,015
    Issued: August 17, 2010
    Inventor(s): Sadowski; Peter L. & Deboer; David M. & Berman; Claude L. & Lesch, Jr.; Paul R. & Holland; Margaret L.
    Assignee(s): Antares Pharma Inc.
    A jet injection device with a fluid chamber in a housing member for holding about 0.02 ml to about 3 ml of a medicament. An injection-assisting needle has an injection end that extends from the housing for inserting into a patient to a depth of up to about 5 mm. A force-generating source is configured to apply a pressure reaching about 100-1000 psi to the medicament in the chamber to expel the medicament through the injecting end of the needle.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      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
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      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
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      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
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      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
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      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
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      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
  • Needle assisted jet injector
    Patent RE44846
    Issued: April 15, 2014
    Assignee(s): Antares Pharma, Inc.
    A jet injection device with a fluid chamber in a housing member for holding about 0.02 ml to about 3 ml of a medicament. An injection-assisting needle has an injection end that extends from the housing for inserting into a patient to a depth of up to about 5 mm. A force-generating source is configured to apply a pressure reaching about 100-1000 psi to the medicament in the chamber to expel the medicament through the injecting end of the needle.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Drug product
  • Needle assisted jet injector
    Patent RE44847
    Issued: April 15, 2014
    Assignee(s): Antares Pharma, Inc.
    A needle assisted jet injector and method for jet injecting medicament are disclosed. In one embodiment of the injector, the needle is retractably located within an injector nozzle assembly. Upon activation of the force generating source, a portion of the needle extends past the nozzle assembly and penetrates the outer layer of skin to deliver the medicament via jet injection to a deeper region. After activation, the needle retracts back into the nozzle assembly. In another embodiment, the needle is fixed to the end of the nozzle assembly. In both embodiments, the length of the portion of the needle that penetrates the skin is less than 5 mm.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Patent use: SUBCUTANEOUS INJECTION OF METHOTREXATE
      ✓ 
      Drug product

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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