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Generic Epanova Availability

Epanova is a brand name of omega-3 polyunsaturated fatty acids, approved by the FDA in the following formulation(s):

EPANOVA (omega-3-carboxylic acids - capsule;oral)

  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: May 5, 2014
    Strength(s): 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS [RLD]

Has a generic version of Epanova been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Epanova. 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.

  • Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids
    Patent 5,792,795
    Issued: August 11, 1998
    Inventor(s): Buser; Thomas & Camporesi; Emilio P.
    Assignee(s): Tillotts Pharma AG
    Inflammatory bowel disease, especially Crohn's disease and ulcerative colitis, is treated by administration of an oral dosage form, containing as an active principle an omega-3 polyunsaturated acid in free acid form or as a pharmaceutically acceptable salt thereof, which releases the acid in the ileum. Preferably the oral dosage form is a gelatine capsule coated with a poly(ethylacrylate-methylmethacrylate).
    Patent expiration dates:
    • May 13, 2017
      ✓ 
      Drug product
  • Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids
    Patent 5,948,818
    Issued: September 7, 1999
    Inventor(s): Buser; Thomas & Camporesi; Emilio P.
    Assignee(s): Tillotts Pharma AG
    Inflammatory bowel disease, especially Crohn's disease and ulcerative colitis, is treated by administration of an oral dosage form, containing as an active principle an omega-3 polyunsaturated acid in free acid form or as a pharmaceutically acceptable salt thereof, which releases the acid in the ileum. Preferably the oral dosage form is a gelatine capsule coated with a poly(ethylacrylate-methylmethacrylate).
    Patent expiration dates:
    • May 13, 2017
      ✓ 
      Drug product
  • Type A gelatin capsule containing PUFA in free acid form
    Patent 7,960,370
    Issued: June 14, 2011
    Inventor(s): Sachetto; Jean-Pierre & Bufton; Roly & Buser; Thomas
    A pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form or a pharmacologically acceptable derivative thereof is contained in a soft gelatin capsule characterized in that the capsule comprises gelatin extracted by an extraction process comprising acid pre-treatment of a collagen source. One advantage of the present invention over a soft gelatin capsule containing the same formulation but comprising gelatin extracted by an extraction process comprising alkali pre-treatment of the collagen source is that the present invention does not harden significantly over time and thus has a longer shelf life.
    Patent expiration dates:
    • February 7, 2025
      ✓ 
      Drug product
  • Type a gelatin capsule containing PUFA in free acid form
    Patent 8,383,678
    Issued: February 26, 2013
    Assignee(s): Chrysalis Pharma AG
    A pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form or a pharmacologically acceptable derivative thereof is contained in a soft gelatin capsule characterized in that the capsule comprises gelatin extracted by an extraction process comprising acid pre-treatment of a collagen source. One advantage of the present invention over a soft gelatin capsule containing the same formulation but comprising gelatin extracted by an extraction process comprising alkali pre-treatment of the collagen source is that the present invention does not harden significantly over time and thus has a longer shelf life.
    Patent expiration dates:
    • February 7, 2025
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA
      ✓ 
      Drug product
  • Type A gelatin capsule containing PUFA in free acid form
    Patent 9,012,501
    Issued: April 21, 2015
    Assignee(s): Chrysalis Pharma AG
    A pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form or a pharmacologically acceptable derivative thereof is contained in a soft gelatin capsule characterized in that the capsule comprises gelatin extracted by an extraction process comprising acid pre-treatment of a collagen source. One advantage of the present invention over a soft to gelatin capsule containing the same formulation but comprising gelatin extracted by an extraction process comprising alkali pre-treatment of the collagen source is that the present invention does not harden significantly over time and thus has a longer shelf life.
    Patent expiration dates:
    • February 7, 2025
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA
      ✓ 
      Drug product
  • DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
    Patent 9,050,308
    Issued: June 9, 2015
    Assignee(s): Omthera Pharmaceuticals, Inc. Chrysalis Pharma AG
    DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented.
    Patent expiration dates:
    • January 4, 2033
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA
  • DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
    Patent 9,050,309
    Issued: June 9, 2015
    Assignee(s): Omthera Pharmaceuticals, Inc. Chrysalis Pharma AG
    DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented.
    Patent expiration dates:
    • January 4, 2033
      ✓ 
      Drug substance
  • Type A gelatin capsule containing PUFA in free acid form
    Patent 9,132,112
    Issued: September 15, 2015
    Assignee(s): CHYSALIS PHARMA AG
    A pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form or a pharmacologically acceptable derivative thereof is contained in a soft gelatin capsule characterized in that the capsule comprises gelatin extracted by an extraction process comprising acid pre-treatment of a collagen source. One advantage of the present invention over a soft gelatin capsule containing the same formulation but comprising gelatin extracted by an extraction process comprising alkali pre-treatment of the collagen source is that the present invention does not harden significantly over time and thus has a longer shelf life.
    Patent expiration dates:
    • February 7, 2025
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA
      ✓ 
      Drug product

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:
    • May 5, 2019 - NEW CHEMICAL ENTITY

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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