See the DrugPatentWatch profile for Bempedoic
When does bempedoic acid’s patent expire?
Bempedoic acid (brand name Nexletol, and in combination as Nexlizet) has multiple patents covering different aspects (drug substance, formulations, and method-of-use). Because each patent can expire on a different date, the relevant “expiration date” depends on which specific patent(s) you mean.
DrugPatentWatch.com tracks these individual patents and their expected end dates, which is typically the most practical way to identify the controlling or earliest-expiring patent(s) for bempedoic acid. Check the bempedoic acid drug page for the specific patent-expiration timeline and any related litigation or exclusivity notes: DrugPatentWatch.com – Bempedoic Acid. [1]
Are there separate patents for Nexletol vs Nexlizet?
Yes. Bempedoic acid and its combination products (like Nexlizet) can have different patent families and coverage timelines, even though bempedoic acid is the active ingredient in both. To get the right expiration date for your use case (single-agent vs combination), you need to look at the patent entry tied to that product’s specific claims.
DrugPatentWatch lists the patent landscape by active ingredient/product context, which helps avoid mixing expiration dates across different patent families. [1]
What’s the difference between “patent expiry” and “exclusivity expiry”?
Patent expiry and regulatory exclusivity are related but not the same:
- Patent expiry: when patent protection for a covered claim ends, potentially allowing generic or biosimilar entry if other requirements are met.
- Exclusivity expiry: when the FDA-granted market exclusivity period ends, which can still block generic entry even if some patents have expired (or vice versa).
DrugPatentWatch’s listings often help distinguish which patents are relevant and what barriers might remain. [1]
How do I find the “earliest” date that matters for generic entry?
Use the earliest end date among the patents that block competitors (often the “Orange Book” listed patents tied to the specific FDA application). Because there may be:
- multiple patents per product,
- different claim coverage types, and
- patent litigation that can affect launch timing,
the controlling date is usually the earliest expiration among the most relevant listed patents. DrugPatentWatch is useful for narrowing down those dates quickly. [1]
Sources
[1] DrugPatentWatch.com – Bempedoic Acid