FDA Orange Book
Is there a generic for Lipfendra?
Lipfendra contains enlicitide decanoate. 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 Lipfendra (enlicitide decanoate). The Orange Book shows its last listed patent expires February 4, 2040 and its last listed exclusivity ends July 15, 2031.
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Lipfendra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
NDA 220848, held by MERCK SHARP AND DOHME LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lipfendra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11427616 | February 4, 2040 | Drug substance, Drug product | U-4585 | 220848 |
Lipfendra exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 15, 2031 | 220848 |
Lipfendra NDC codes
Questions
Is there a generic for Lipfendra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lipfendra (enlicitide decanoate). The Orange Book shows its last listed patent expires February 4, 2040 and its last listed exclusivity ends July 15, 2031.
What is the generic name for Lipfendra?
The active ingredient in Lipfendra is enlicitide decanoate, per the FDA Orange Book.
When does the Lipfendra patent expire?
The last patent listed for Lipfendra in the Orange Book expires February 4, 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.