FDA Orange Book
Is there a generic for Scenesse?
Scenesse contains afamelanotide. 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 Scenesse (afamelanotide). The Orange Book shows its last listed patent expires January 20, 2033 and its last listed exclusivity ends October 8, 2026.
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Scenesse products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| implant, subcutaneous | 16MG | Marketed (Rx) | None | 0 | None |
NDA 210797, held by CLINUVEL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Scenesse patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8334265 | January 20, 2033 | Method of use | U-2638 | 210797 |
Scenesse exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-270 | Orphan drug exclusivity | October 8, 2026 | 210797 |
Scenesse NDC codes
Questions
Is there a generic for Scenesse?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Scenesse (afamelanotide). The Orange Book shows its last listed patent expires January 20, 2033 and its last listed exclusivity ends October 8, 2026.
What is the generic name for Scenesse?
The active ingredient in Scenesse is afamelanotide, per the FDA Orange Book.
When does the Scenesse patent expire?
The last patent listed for Scenesse in the Orange Book expires January 20, 2033. 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.