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Generic Vascepa Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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] [AB]
  • Manufacturer: AMARIN PHARMS
    Approval date: February 16, 2017
    Strength(s): 500MG [RLD]

Has a generic version of Vascepa been approved?

A generic version of Vascepa 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 Vascepa and have been approved by the FDA:

icosapent ethyl capsule;oral

  • Manufacturer: DR REDDYS
    Approval date: August 7, 2020
    Strength(s): 1GM [AB]
  • Manufacturer: HIKMA
    Approval date: May 21, 2020
    Strength(s): 1GM [AB]

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: 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.

  • Stable pharmaceutical composition and methods of using same
    Patent 10,010,517
    Issued: July 3, 2018
    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: USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
  • Methods of reducing triglycerides and LDL-C
    Patent 10,265,287
    Issued: April 23, 2019
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

    Patent expiration dates:

    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON ROSUVASTATIN THERAPY
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 10,278,935
    Issued: May 7, 2019
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 10,278,936
    Issued: May 7, 2019
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 10,278,937
    Issued: May 7, 2019
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT (CV DEATH, CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND DIABETES MELLITUS
  • Patent 10,383,840

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND AT LEAST ONE RISK FACTOR FOR CARDIOVASCULAR DISEASE
  • Patent 10,555,924

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF UNSTABLE ANGINA IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
  • Patent 10,555,925

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
  • Patent 10,568,861

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
  • Patent 10,576,054

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A MAJOR CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CARDIOVASCULAR DISEASE
  • Patent 10,668,042

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
  • Patent 10,786,478

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A THIRD AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>=150 MG/DL) AND ESTABLISHED CARDIOVASCULAR DISEASE
    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND OR FURTHER CARDIOVASCULAR (CV) EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>= 150 MG/DL) AND DIABETES MELLITUS AND 2 OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
  • Patent 10,792,267

    Patent expiration dates:

    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION, STROKE, BOTH IN AN ADULT PATIENT WITH TYPE 2 DIABETES MELLITUS
  • Patent 10,792,270

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
  • Patent 10,842,766

    Patent expiration dates:

    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDES AND ATRIAL FIBRILLATION
  • Patent 10,842,768

    Patent expiration dates:

    • June 15, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
  • Patent 10,881,632

    Patent expiration dates:

    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION AND TRIGLYCERIDE LEVELS OF GREATER THAN 500 MG/DL
  • Patent 10,894,028

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND ESTABLISHED CV DISEASE OR DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
  • 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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Compositions and methods for lowering triglycerides
    Patent 8,410,086
    Issued: April 2, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

    Patent expiration dates:

    • June 15, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
  • 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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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
      ✓ 
      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 8,454,994
    Issued: June 4, 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: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
  • Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
    Patent 8,455,472
    Issued: June 4, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

    Patent expiration dates:

    • June 15, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
  • 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
      ✓ 
      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:

    • February 9, 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:

    • February 9, 2030
      ✓ 
      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:

    • February 9, 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
      ✓ 
      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
      ✓ 
      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
    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
    • 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 8,617,594
    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
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
  • Methods of treating mixed dyslipidemia
    Patent 8,618,166
    Issued: December 31, 2013
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

    Patent expiration dates:

    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
  • 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
      ✓ 
      Patent use: USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
    • April 29, 2030
      ✓ 
      Patent use: METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
    • 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 8,642,077
    Issued: February 4, 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
      ✓ 
      Patent use: USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
  • Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
    Patent 8,669,245
    Issued: March 11, 2014
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

    Patent expiration dates:

    • June 15, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO LOWER TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
  • Methods of treating mixed dyslipidemia
    Patent 8,680,144
    Issued: March 25, 2014
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

    Patent expiration dates:

    • February 9, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO TREAT MIXED HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
  • Methods of treating mixed dyslipidemia
    Patent 8,691,871
    Issued: April 8, 2014
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

    Patent expiration dates:

    • April 29, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
  • Stable pharmaceutical composition and methods of using same
    Patent 8,703,185
    Issued: April 22, 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
      ✓ 
      Patent use: USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
  • Stable pharmaceutical composition and methods of using same
    Patent 8,709,475
    Issued: April 29, 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
      ✓ 
      Patent use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
  • Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy
    Patent 8,710,041
    Issued: April 29, 2014
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

    Patent expiration dates:

    • June 15, 2030
      ✓ 
      Patent use: USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
  • Composition and/or method for preventing onset and/or recurrence of cardiovascular events
    Patent 9,198,892
    Issued: December 1, 2015
    Assignee(s): MOCHIDA PHARMACEUTICAL CO., LTD.

    Provided are composition and/or methods useful in preventing onset and/or recurrence of cardiovascular events, especially in patients who have escaped the unstable period after cardiovascular angioplasty or in hyperlipidemia patients who have been treated with HMG-CoA RI.

    Patent expiration dates:

    • September 25, 2027
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF ONSET AND/OR RECURRENCE OF CARDIOVASCULAR EVENTS IN A PATIENT WHO HAS ESCAPED THE UNSTABLE PERIOD AFTER CARDIOVASCULAR ANGIOPLASTY
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,603,826
    Issued: March 28, 2017
    Assignee(s): AMARIN PHARMACEUTICALS IRELAND LIMITED

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,610,272
    Issued: April 4, 2017
    Assignee(s): Amarin Pharmaceuticals Ireland Limited

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,623,001
    Issued: April 18, 2017
    Assignee(s): AMARIN PHARMACEUTICALS IRELAND LIMITED

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,693,984
    Issued: July 4, 2017
    Assignee(s): AMARIN PHARMACEUTICALS IRELAND LIMITED

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,693,985
    Issued: July 4, 2017
    Assignee(s): AMARIN PHARMACEUTICALS IRELAND LIMITED

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,693,986
    Issued: July 4, 2017
    Assignee(s): AMARIN PHARMACEUTICALS IRELAND LIMITED

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
  • Composition for preventing the occurrence of cardiovascular event in multiple risk patient
    Patent 9,700,537
    Issued: July 11, 2017
    Assignee(s): MOCHIDA PHARMACEUTICAL CO., LTD.

    Disclosed is a composition which is useful for preventing the occurrence of a cardiovascular event, particularly a composition which is expected to show a prophylactic effect on a cardiovascular event occurring in a hypercholesterolemia patient despite providing the patient with a treatment with HMG-CoA RI or a cardiovascular event occurring in a multiple risk patient.

    Patent expiration dates:

    • May 31, 2027
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE OCCURRENCE OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH HYPERCHOLESTEROLEMIA
  • Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
    Patent 9,918,954
    Issued: March 20, 2018
    Assignee(s): AMARIN PHARMACEUTICALS IRELAND LIMITED

    In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

    Patent expiration dates:

    • June 28, 2033
      ✓ 
      Patent use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS

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:

    • December 13, 2022 - ADJUNCT TO MAX TOLERATED STATIN TX TO REDUCE RISK OF MI, STROKE, CORONARY REVASCULARIZATION, & UNSTABLE ANGINA REQUIRING HOSPITALIZATION IN ADULTS W/ ELEVATED TG LEVELS & ESTABLISHED CV DISEASE OR DIABETES MELLITUS & 2+ RISK FACTORS FOR CV DISEASE

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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