Prescription medicine
Afamelanotide Brand names: Scenesse
Afamelanotide (Scenesse) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the afamelanotide FDA label on DailyMed (effective May 11, 2026, CLINUVEL INC.); the NDA 210797 record on Drugs@FDA; every afamelanotide label on DailyMed.
Highlights of the record
FDA label of May 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
Forms and strengths
- 16 mg
Implant.
On the market
- Earliest approval on file
- October 8, 2019 Scenesse, Clivunel Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 20, 2033 Scenesse injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19 through July 30, 2026
What is afamelanotide used for?
From the label: indications and usageSCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Source: FDA drug label (SCENESSE), NDA210797 (Clivunel Inc), as published by CLINUVEL INC., effective May 11, 2026 (SPL set 94f53286-11dd-7fbb-e053-2a95a90a7c48), via openFDA; the full label on DailyMed
Is there a generic for afamelanotide (Scenesse)?
No generic afamelanotide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Scenesse injection, the last expiring on January 20, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for afamelanotide?
The FDA Adverse Event Reporting System holds 19 reports that list afamelanotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Afamelanotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other