Generic Nexlizet Availability
Last updated on Aug 7, 2024.
Nexlizet is a brand name of bempedoic acid/ezetimibe, approved by the FDA in the following formulation(s):
NEXLIZET (bempedoic acid; ezetimibe - tablet;oral)
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Manufacturer: ESPERION THERAPS INC
Approval date: February 26, 2020
Strength(s): 180MG;10MG [RLD]
Has a generic version of Nexlizet been approved?
No. There is currently no therapeutically equivalent version of Nexlizet available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nexlizet. 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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Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Patent 10,912,751
Issued: February 9, 2021
Inventor(s): Newton Roger Schofield & Rosenberg Noah Laban & MacDougall Diane Elaine
Assignee(s): Esperion Therapeutics, Inc.Disclosed herein are compositions comprising fixed doses of ETC-1002 and Ezetimibe. Also disclosed herein are methods for using fixed doses of ETC-1002 and Ezetimibe. Uses include methods of treating cardiovascular disease or reducing the risk of cardiovascular disease in a subject. Uses also include methods of treating hypercholesterolemia in a subject.
Patent expiration dates:
- March 14, 2036✓
- March 14, 2036✓
- March 14, 2036
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Patent 11,613,511
Patent expiration dates:
- June 19, 2040✓
- June 19, 2040
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Patent 11,744,816
Patent expiration dates:
- March 14, 2036✓
- March 14, 2036✓
- March 14, 2036
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Patent 11,760,714
Patent expiration dates:
- June 19, 2040✓
- June 19, 2040
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Patent 11,926,584
Patent expiration dates:
- June 19, 2040✓
- June 19, 2040
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Patent 7,335,799
Patent expiration dates:
- December 3, 2030✓
- December 3, 2030
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
- March 22, 2027 - EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, ALONE OR IN COMBINATION WITH OTHER LDL-C LOWERING THERAPIES, TO REDUCE LDL-C IN ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
- March 22, 2027 - TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND CORONARY REVASCULARIZATION IN ADULTS WHO ARE UNABLE TO TAKE RECOMMENDED STATIN THERAPY (INCLUDING THOSE NOT TAKING A STATIN) WITH ESTABLISHED CARDIOVASCULAR DISEASE (CVD), OR AT HIGH RISK FOR A CVD EVENT BUT
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- Drug class: antihyperlipidemic combinations
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
