FDA Orange Book
Is there a generic for Nexlizet?
Nexlizet contains bempedoic acid and ezetimibe. 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 Nexlizet (bempedoic acid and ezetimibe). 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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Nexlizet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 180MG;10MG | Marketed (Rx) | None | 0 | None |
NDA 211617, 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.
Nexlizet patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7335799 | December 3, 2030 | Drug substance | None | 211617 |
| 11744816 | March 14, 2036 | Method of use | U-3883 | 211617 |
| 10912751 | March 14, 2036 | Method of use | U-3884 | 211617 |
| 11744816 | March 14, 2036 | Method of use | U-3692 | 211617 |
| 10912751 | March 14, 2036 | Method of use | U-3224 | 211617 |
| 11926584 | June 19, 2040 | Method of use | U-3873 | 211617 |
| 12404227 | June 19, 2040 | Drug substance | U-4258 | 211617 |
| 11613511 | June 19, 2040 | Drug substance | None | 211617 |
| 11760714 | June 19, 2040 | Drug product | None | 211617 |
| 12398087 | June 19, 2040 | Drug substance, Drug product | None | 211617 |
Nexlizet exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-943 | New indication | March 22, 2027 | 211617 |
| I-945 | New indication | March 22, 2027 | 211617 |
Nexlizet NDC codes
Questions
Is there a generic for Nexlizet?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nexlizet (bempedoic acid and ezetimibe). 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 Nexlizet?
The active ingredient in Nexlizet is bempedoic acid and ezetimibe, per the FDA Orange Book.
When does the Nexlizet patent expire?
The last patent listed for Nexlizet 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.