Generic Adrenalin Availability
Last updated on Nov 6, 2024.
See also: Generic Adrenaclick
Adrenalin is a brand name of epinephrine, approved by the FDA in the following formulation(s):
ADRENALIN (epinephrine - solution;intramuscular, intravenous, subcutaneous)
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Manufacturer: ENDO OPERATIONS
Approval date: December 7, 2012
Strength(s): EQ 1MG BASE/ML (EQ 1MG BASE/ML) [RLD] -
Manufacturer: ENDO OPERATIONS
Approval date: December 18, 2013
Strength(s): EQ 30MG BASE/30ML (EQ 1MG BASE/ML) [RLD] [AP]
ADRENALIN (epinephrine - solution;intravenous)
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Manufacturer: ENDO OPERATIONS
Approval date: April 21, 2023
Strength(s): 2MG/250ML (8MCG/ML) [RLD], 4MG/250ML (16MCG/ML) [RLD], 5MG/250ML (20MCG/ML) [RLD], 8MG/250ML (32MCG/ML) [RLD], 10MG/250ML (40MCG/ML) [RLD]
Has a generic version of Adrenalin been approved?
A generic version of Adrenalin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Adrenalin and have been approved by the FDA:
epinephrine solution;intramuscular, intravenous, subcutaneous
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Manufacturer: AM REGENT
Approval date: September 6, 2024
Strength(s): EQ 30MG BASE/30ML (EQ 1MG BASE/ML) [AP] -
Manufacturer: INTL MEDICATION SYS
Approval date: April 24, 2020
Strength(s): EQ 30MG BASE/30ML (EQ 1MG BASE/ML) [AP]
Note: No generic formulation of the following product is available.
- epinephrine - solution;intravenous
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Adrenalin. 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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Epinephrine formulations
Patent 10,130,592
Issued: November 20, 2018
Inventor(s): Kannan Vinayagam & Irish Patrick & Bergren Michael
Assignee(s): PAR PHARMACEUTICAL, INC.Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.
Patent expiration dates:
- March 13, 2035✓
- March 13, 2035
-
Epinephrine compositions and containers
Patent 10,653,646
Issued: May 19, 2020
Inventor(s): Akasapu Prem Sagar & Soppimath Kumaresh & Puri Reema Ajitkumar & Ilitchev Iouri V. & Patel Milan & Tendulkar Pooja H.
Assignee(s): Nevakar Inc.The inventive subject matter provides ready-to-administer, preferably anti-oxidant free, epinephrine compositions with improved stability, and methods for preparing the same. Contemplated compositions can be packaged using blow-fill-seal technology or packaged into flexible IV bags and maintain degradation of the epinephrine at a level of less than 5 wt % when stored over at least one months at between 2-40° C.
Patent expiration dates:
- March 21, 2039✓
- March 21, 2039
-
Epinephrine compositions and containers
Patent 11,083,698
Issued: August 10, 2021
Inventor(s): Akasapu Prem Sagar & Soppimath Kumaresh & Puri Reema Ajitkumar & Ilitchev Iouri V. & Patel Milan & Tendulkar Pooja H.
Assignee(s): NEVAKAR INC.The inventive subject matter provides ready-to-administer, preferably anti-oxidant free, epinephrine compositions with improved stability, and methods for preparing the same. Contemplated compositions can be packaged using blow-fill-seal technology or packaged into flexible IV bags and maintain degradation of the epinephrine at a level of less than 5 wt % when stored over at least one months at between 2-40° C.
Patent expiration dates:
- March 21, 2039✓
- March 21, 2039
-
Epinephrine compositions and containers
Patent 11,207,280
Issued: December 28, 2021
Inventor(s): Akasapu Prem Sagar & Soppimath Kumaresh & Puri Reema Ajitkumar & Ilitchev Iouri V. & Patel Milan & Tendulkar Pooja H.
Assignee(s): Nevakar Injectables Inc.The inventive subject matter provides ready-to-administer, preferably anti-oxidant free, epinephrine compositions with improved stability, and methods for preparing the same. Contemplated compositions can be packaged using blow-fill-seal technology or packaged into flexible IV bags and maintain degradation of the epinephrine at a level of less than 5 wt % when stored over at least one months at between 2-40° C.
Patent expiration dates:
- March 21, 2039✓
- March 21, 2039
-
Patent 12,133,837
Patent expiration dates:
- March 21, 2039✓
- March 21, 2039
-
Epinephrine formulations
Patent 9,119,876
Issued: September 1, 2015
Inventor(s): Kannan Vinayagam & Irish Patrick & Bergren Michael
Assignee(s): PAR PHARMACEUTICAL, INC.Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.
Patent expiration dates:
- March 13, 2035✓
- March 13, 2035
-
Epinephrine formulations
Patent 9,295,657
Issued: March 29, 2016
Inventor(s): Kannan Vinayagam & Irish Patrick & Bergren Michael
Assignee(s): Par Pharmaceutical, Inc.Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.
Patent expiration dates:
- March 13, 2035✓
- March 13, 2035
More about Adrenalin (epinephrine)
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- During pregnancy
- Drug class: adrenergic bronchodilators
- Breastfeeding
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Patient resources
- Adrenalin drug information
- Adrenalin (Epinephrine Inhalation) (Advanced Reading)
- Adrenalin (Epinephrine Injection) (Advanced Reading)
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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. |
AP | Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.