FDA Orange Book
Is there a generic for Imcivree?
Imcivree contains setmelanotide acetate. 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 Imcivree (setmelanotide acetate). The Orange Book shows its last listed patent expires July 4, 2034 and its last listed exclusivity ends December 20, 2031.
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Imcivree products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 10MG BASE/ML (EQ 10MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 213793, held by RHYTHM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Imcivree patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9458195 | October 13, 2027 | Drug substance, Drug product | None | 213793 |
| 8039435 | August 21, 2032 | Drug substance, Drug product | None | 213793 |
| 11129869 | July 4, 2034 | Drug product | None | 213793 |
Imcivree exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-336 | Orphan drug exclusivity | November 25, 2027 | 213793 |
| NPP | New patient population | December 20, 2027 | 213793 |
| I-987 | New indication | March 19, 2029 | 213793 |
| ODE-402 | Orphan drug exclusivity | June 16, 2029 | 213793 |
| ODE-508 | Orphan drug exclusivity | December 20, 2031 | 213793 |
| ODE-509 | Orphan drug exclusivity | December 20, 2031 | 213793 |
Imcivree NDC codes
Questions
Is there a generic for Imcivree?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Imcivree (setmelanotide acetate). The Orange Book shows its last listed patent expires July 4, 2034 and its last listed exclusivity ends December 20, 2031.
What is the generic name for Imcivree?
The active ingredient in Imcivree is setmelanotide acetate, per the FDA Orange Book.
When does the Imcivree patent expire?
The last patent listed for Imcivree in the Orange Book expires July 4, 2034. 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.