FDA Orange Book
Is there a generic for Nexletol?
Nexletol contains bempedoic acid. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nexletol (bempedoic acid). The Orange Book shows its last listed patent expires June 19, 2040 and its last listed exclusivity ends March 22, 2027.
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Nexletol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 180MG | Marketed (Rx) | None | 0 | None |
NDA 211616, held by ESPERION THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nexletol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7335799 | December 3, 2030 | Drug substance | None | 211616 |
| 11744816 | March 14, 2036 | Method of use | U-3883 | 211616 |
| 11926584 | June 19, 2040 | Method of use | U-3873 | 211616 |
| 12404227 | June 19, 2040 | Drug substance | U-4258 | 211616 |
| 11760714 | June 19, 2040 | Drug product | None | 211616 |
| 12398087 | June 19, 2040 | Drug substance, Drug product | None | 211616 |
| 11613511 | June 19, 2040 | Drug substance | None | 211616 |
Nexletol exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-943 | New indication | March 22, 2027 | 211616 |
| I-944 | New indication | March 22, 2027 | 211616 |
Nexletol NDC codes
Questions
Is there a generic for Nexletol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nexletol (bempedoic acid). The Orange Book shows its last listed patent expires June 19, 2040 and its last listed exclusivity ends March 22, 2027.
What is the generic name for Nexletol?
The active ingredient in Nexletol is bempedoic acid, per the FDA Orange Book.
When does the Nexletol patent expire?
The last patent listed for Nexletol in the Orange Book expires June 19, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.