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Generic Nexletol Availability

Last updated on Sep 8, 2021.

Nexletol is a brand name of bempedoic acid, approved by the FDA in the following formulation(s):

NEXLETOL (bempedoic acid - tablet;oral)

  • Manufacturer: ESPERION THERAPS INC
    Approval date: February 21, 2020
    Strength(s): 180MG [RLD]

Has a generic version of Nexletol been approved?

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

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

  • Hydroxyl compounds and compositions for cholesterol management and related uses
    Patent 10,118,881
    Issued: November 6, 2018
    Assignee(s): Esperion Therapeutics, Inc.

    The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

    Patent expiration dates:

    • December 23, 2023
      ✓ 
      Patent use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
  • Patent 10,941,095

    Patent expiration dates:

    • December 23, 2023
      ✓ 
      Patent use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
  • Hydroxyl compounds and compositions for cholesterol management and related uses
    Patent 7,335,799
    Issued: February 26, 2008
    Inventor(s): Dasseux; Jean-Louis Henri & Oniciu; Carmen Daniela
    Assignee(s): Esperion Therapeutics, Inc.

    The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

    Patent expiration dates:

    • December 3, 2025
      ✓ 
      Drug substance
  • Hydroxyl compounds and compositions for cholesterol management and related uses
    Patent 8,497,301
    Issued: July 30, 2013
    Assignee(s): Esperion Therapeutics, Inc.

    The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

    Patent expiration dates:

    • December 23, 2023
      ✓ 
      Patent use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
  • Hydroxyl compounds and compositions for cholesterol management and related uses
    Patent 9,000,041
    Issued: April 7, 2015
    Assignee(s): Esperion Therapeutics, Inc.

    The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

    Patent expiration dates:

    • December 23, 2023
      ✓ 
      Patent use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
  • Hydroxyl compounds and compositions for cholesterol management and related uses
    Patent 9,624,152
    Issued: April 18, 2017
    Assignee(s): Esperion Therapeutics, Inc.

    The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

    Patent expiration dates:

    • December 23, 2023
      ✓ 
      Patent use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY FOR INHIBITING CHOLESTEROL SYNTHESIS TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE

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:

    • February 21, 2025 - NEW CHEMICAL ENTITY

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.