Bempedoic acid is anticipated to become available as a generic in 2026, following patent expirations. This development is significant for patients and the pharmaceutical market.
When can generic bempedoic acid be sold?
The primary patents protecting bempedoic acid are set to expire around 2026 [1]. This expiration will allow generic manufacturers to produce and market their own versions of the drug, likely leading to increased accessibility and potentially lower costs.
What is bempedoic acid used for?
Bempedoic acid is a medication prescribed to lower low-density lipoprotein (LDL) cholesterol in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional LDL-lowering therapy [2]. It works by inhibiting a key enzyme in the liver that produces cholesterol.
How does bempedoic acid work?
Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. ACL is an enzyme involved in the synthesis of cholesterol in the liver. By inhibiting this enzyme, bempedoic acid reduces the production of cholesterol, thereby lowering LDL-C levels [2]. It is a prodrug that is activated in the liver.
What are the potential risks or side effects?
Common side effects associated with bempedoic acid include hyperuricemia and tendon rupture [2]. Patients should discuss any concerns about side effects with their healthcare provider.
What is the difference between bempedoic acid and statins?
Bempedoic acid offers an alternative for patients who cannot tolerate statins or require additional LDL-lowering beyond statin therapy. Unlike statins, bempedoic acid is activated in the liver and does not significantly impact skeletal muscle, which is thought to be why it causes fewer muscle-related side effects [2].
What is the current brand name for bempedoic acid?
The current brand name for bempedoic acid in the United States is Nexletol [3]. It is also available in combination with ezetimibe under the brand name Nexlizet.
Who manufactures bempedoic acid?
Bempedoic acid is manufactured by Esperion Therapeutics [3].
Will bempedoic acid be cheaper as a generic?
When bempedoic acid becomes available as a generic, it is expected that prices will decrease significantly due to market competition. This is a typical pattern observed with the introduction of generic drugs [1].
How do patent expirations affect drug prices?
Patent expirations are crucial for generic drug availability. Once a drug's patent protection ends, other companies can legally manufacture and sell generic versions. This competition generally leads to lower prices for consumers and healthcare systems [1].
Where can I find more information on bempedoic acid patents?
Information on drug patents, including those for bempedoic acid, can be found on specialized databases such as DrugPatentWatch.com [1]. These resources track patent filings, expiration dates, and potential patent challenges.
What are the clinical trial results for bempedoic acid?
Clinical trials have demonstrated that bempedoic acid effectively reduces LDL-C levels. In the CLEAR Outcomes trial, bempedoic acid reduced the risk of major adverse cardiovascular events in patients with atherosclerotic cardiovascular disease who were either statin-intolerant or on maximally tolerated statin therapy [2].
Sources:
1. DrugPatentWatch.com
2. Bempedoic Acid FDA Label
3. Nexletol Information