No generic versions of Nexletol (bempedoic acid) are expected to be available in 2025 based on current patent information. DrugPatentWatch.com indicates that the patents protecting Nexletol have expiry dates beyond 2025 [1].
When does Nexletol exclusivity expire?
The primary patents for Nexletol are scheduled to expire in 2035 [1]. This means that, barring any successful patent challenges or settlements, no generic versions of Nexletol are likely to enter the market until that time [1].
What is Nexletol used for?
Nexletol is a prescription medication used to lower LDL cholesterol in adults with primary hyperlipidemia or mixed hyperlipidemia, when used in combination with a maximally tolerated statin or as monotherapy if statins are not tolerated [2].
Can biosimilars enter before patent expiry?
For small molecule drugs like Nexletol, the term "biosimilar" is not applicable. Instead, generic versions are developed. Generic drug makers can challenge patents before their expiry date, which could potentially lead to earlier market entry if the challenge is successful [1]. However, there is no indication of such challenges for Nexletol that would precede the 2035 expiry.
Who makes Nexletol?
Nexletol is manufactured by Esperion Therapeutics [3].
How does Nexletol work?
Nexletol is an adenosine triphosphate-citrate lyase (ACL) inhibitor. It works by reducing the liver's production of cholesterol [2].
What are the risks associated with Nexletol?
Common side effects of Nexletol include upper respiratory tract infections, muscle spasms, back pain, and increased blood uric acid [2].
What are alternative treatments for high cholesterol?
Besides Nexletol, other treatments for high cholesterol include statins, ezetimibe, PCSK9 inhibitors, and bile acid sequestrants. The choice of treatment depends on the individual patient's condition and tolerance to medications [2].
Sources:
1. https://drugpatentwatch.com/
2. Nexletol Prescribing Information.
3. Esperion Therapeutics, Inc. Press Releases.