Generic Vascepa Availability

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

VASCEPA (icosapent ethyl - capsule;oral)

  • Manufacturer: AMARIN PHARMS
    Approval date: July 26, 2012
    Strength(s): 1GM [RLD]

Has a generic version of Vascepa been approved?

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

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

  • Highly purified ethyl EPA and other EPA derivatives
    Patent 8,188,146
    Issued: May 29, 2012
    Inventor(s): Peet; Malcolm & Vaddadi; Krishna S.
    Assignee(s): Amarin Corporation Plc.
    A pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA and where less than 5%, and preferably less than 3%, is in the form of DHA is provided.
    Patent expiration dates:
    • January 27, 2020
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      Drug substance
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      Drug product
  • Methods of treating hypertriglyceridemia
    Patent 8,293,727
    Issued: October 23, 2012
    Inventor(s): Manku; Mehar & Osterloh; Ian & Wicker; Pierre & Braeckman; Rene & Soni; Paresh
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,293,728
    Issued: October 23, 2012
    Inventor(s): Manku; Mehar & Osterloh; Ian & Wicker; Pierre & Braeckman; Rene & Soni; Paresh
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,298,554
    Issued: October 30, 2012
    Inventor(s): Manku; Mehar
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
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      Drug product
  • Methods of treating hypertriglyceridemia
    Patent 8,314,086
    Issued: November 20, 2012
    Inventor(s): Manku; Mehar & Osterloh; Ian & Wicker; Pierre & Braeckman; Rene & Soni; Paresh
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,318,715
    Issued: November 27, 2012
    Inventor(s): Manku; Mehar & Osterloh; Ian & Wicker; Pierre & Braeckman; Rene & Soni; Paresh
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,357,677
    Issued: January 22, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,367,652
    Issued: February 5, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,377,920
    Issued: February 19, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,399,446
    Issued: March 19, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,415,335
    Issued: April 9, 2013
    Assignee(s): Amarin Pharmaceutical Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,426,399
    Issued: April 23, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,431,560
    Issued: April 30, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,440,650
    Issued: May 14, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • February 9, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,445,003
    Issued: May 21, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular related diseases.
    Patent expiration dates:
    • April 29, 2030
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,445,013
    Issued: May 21, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,501,225
    Issued: August 6, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,518,929
    Issued: August 27, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • April 29, 2030
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,524,698
    Issued: September 3, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • April 29, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating hypertriglyceridemia
    Patent 8,546,372
    Issued: October 1, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
    Patent expiration dates:
    • April 29, 2030
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,551,521
    Issued: October 8, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
    Patent 8,563,608
    Issued: October 22, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to methods of reducing triglyceride levels in statin-treated subjects having a triglyceride level of 500 mg/dl to 1500 mg/dl.
    Patent expiration dates:
    • April 29, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,617,593
    Issued: December 31, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,617,594
    Issued: December 31, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Stable pharmaceutical composition and methods of using same
    Patent 8,623,406
    Issued: January 7, 2014
    Assignee(s): Amarin Pharmaceuticals Ireland Limited
    The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
    Patent expiration dates:
    • April 29, 2030
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      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA

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:
    • July 26, 2015 -

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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