Generic Otrexup Availability
Last updated on Sep 11, 2024.
Otrexup is a brand name of methotrexate, approved by the FDA in the following formulation(s):
OTREXUP (methotrexate - solution;subcutaneous)
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Manufacturer: OTTER PHARMS
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: OTTER PHARMS
Approval date: November 7, 2014
Strength(s): 7.5MG/0.4ML (7.5MG/0.4ML) (discontinued) [RLD] -
Manufacturer: OTTER PHARMS
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.
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Injector safety device
Patent 10,709,844
Issued: July 14, 2020
Inventor(s): Sund Julius C. & Lagman Eric & Hoeft Peter A. & Lesch & Jr. Paul R. & Kramer Thomas E.
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✓
- March 10, 2029
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Prefilled syringe injector
Patent 11,446,441
Issued: September 20, 2022
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:
- January 24, 2026✓
- January 24, 2026
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Patent 11,497,753
Patent expiration dates:
- March 19, 2030✓
- March 19, 2030
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Patent 11,684,723
Patent expiration dates:
- March 10, 2029✓
- March 10, 2029
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Patent 8,021,335
Patent expiration dates:
- October 4, 2026✓
- October 4, 2026
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Hazardous agent injection system
Patent 8,480,631
Issued: July 9, 2013
Inventor(s): Wotton Paul & Sadowsky Peter L. & Hayes John William
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 C, Tand bioavailability of the needle-assisted jet injected methotrexate falls between about 80% and about 125% of the C, Tand bioavailability of methotrexate delivered by a hand-powered syringe.
Patent expiration dates:
- March 19, 2030✓✓
- March 19, 2030
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Prefilled syringe jet injector
Patent 8,562,564
Issued: October 22, 2013
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:
- January 24, 2026✓
- January 24, 2026
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Hazardous agent injection system
Patent 8,579,865
Issued: November 12, 2013
Inventor(s): Wotton Paul & Sadowski Peter L. & Hayes John William
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✓✓
- March 19, 2030
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Injector safety device
Patent 8,814,834
Issued: August 26, 2014
Inventor(s): Sund Julius & Lagman Eric & Hoeft Peter & Lesch & Jr. Paul R. & Kramer Tom
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✓
- May 27, 2031
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Hazardous agent injection system
Patent 8,945,063
Issued: February 3, 2015
Inventor(s): Wotton Paul K. & Sadowski Peter L. & Hayes John William
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✓✓
- March 19, 2030
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Hazardous agent injection system
Patent 9,421,333
Issued: August 23, 2016
Inventor(s): Wotton Paul K. & Sadowski Peter L. & Hayes John W.
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✓✓
- March 19, 2030
-
Prefilled syringe jet injector
Patent 9,533,102
Issued: January 3, 2017
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:
- January 24, 2026✓
- January 24, 2026
-
Prefilled syringe jet injector
Patent 9,629,959
Issued: April 25, 2017
Inventor(s): Lesch 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:
- January 24, 2026✓
- January 24, 2026
-
Injector safety device
Patent 9,867,949
Issued: January 16, 2018
Inventor(s): Sund Julius C. & Lagman Eric & Hoeft Peter & Lesch & Jr. Paul R. & KraMer Thomas E.
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✓
- March 10, 2029
More about Otrexup (methotrexate)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (2)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: antimetabolites
- Breastfeeding
- En español
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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
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