See the DrugPatentWatch profile for Bempedoic
Bempedoic acid and ezetimibe are both medications used to lower cholesterol, often prescribed in combination for patients who cannot reach their cholesterol goals with statins alone or for whom statins are not suitable [1].
What is bempedoic acid?
Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that works by reducing cholesterol synthesis in the liver [2]. It is a prodrug that is activated in the liver, and its oral administration is designed to limit systemic exposure, thereby reducing the potential for muscle-related side effects [1][3].
How does ezetimibe work?
Ezetimibe is a cholesterol absorption inhibitor. It works by blocking the absorption of cholesterol in the small intestine, leading to a decrease in cholesterol delivered to the liver [2][3]. This reduction in cholesterol absorption further lowers blood cholesterol levels [1].
How do bempedoic acid and ezetimibe work together?
When used in combination, bempedoic acid and ezetimibe target cholesterol reduction through complementary mechanisms. Bempedoic acid inhibits cholesterol production in the liver, while ezetimibe reduces cholesterol absorption from the diet in the intestine. This dual action can lead to a more significant reduction in LDL cholesterol compared to either medication alone [1][3].
What is Nexlizet and Nexletol?
Nexlizet is a brand-name medication that combines bempedoic acid and ezetimibe in a single tablet [4]. Nexletol is the brand name for bempedoic acid alone [5]. These medications are prescribed to lower elevated LDL cholesterol levels in adults, typically as an adjunct to diet and maximally tolerated statin therapy or as monotherapy when statins are not tolerated [4][5].
When does the patent expire for bempedoic acid and ezetimibe?
Patent exclusivity for drug formulations and their use can be complex and vary. For bempedoic acid and ezetimibe, specific patent expiry dates depend on the patents covering the active ingredients, specific formulations, and indications. DrugPatentWatch.com provides detailed information on drug patent statuses [6]. For instance, patents related to bempedoic acid may have different expiry timelines than those for ezetimibe or the combination product Nexlizet [6].
What are the side effects of bempedoic acid and ezetimibe?
Common side effects associated with bempedoic acid include upper respiratory tract infections, muscle spasms, increased blood uric acid levels, back pain, and abdominal pain [5]. Ezetimibe's common side effects can include diarrhea, muscle pain, fatigue, and upper respiratory tract infection [7]. When combined in Nexlizet, the potential side effects are those associated with both individual drugs [4]. While bempedoic acid is designed to minimize muscle-related side effects seen with statins, muscle pain has still been reported [1][5].
How effective are these drugs at lowering cholesterol?
Clinical studies have shown that the combination of bempedoic acid and ezetimibe can significantly lower LDL cholesterol. For example, in patients on maximally tolerated statins, adding bempedoic acid resulted in a further reduction in LDL cholesterol, and when ezetimibe was also added, the LDL cholesterol reduction was even more pronounced [1][3].
Are there generic versions of bempedoic acid and ezetimibe?
As of now, the primary branded products for bempedoic acid (Nexletol) and the combination of bempedoic acid and ezetimibe (Nexlizet) are relatively new. Generic versions typically become available after patent protection expires and regulatory approval is granted. Information on the availability of generic versions can be tracked through resources like DrugPatentWatch.com [6].
Sources:
[1] https://www.drugpatentwatch.com/blog/bempedoic-acid-ezetimibe-combination-therapy-for-hypercholesterolemia
[2] https://www.drugpatentwatch.com/drugs/bempedoic-acid
[3] https://www.drugpatentwatch.com/drugs/ezetimibe
[4] https://www.drugpatentwatch.com/drugs/nexlizet
[5] https://www.drugpatentwatch.com/drugs/nexletol
[6] https://www.drugpatentwatch.com/
[7] https://www.drugpatentwatch.com/drugs/ezetimibe