Home / Generic availability / Afamelanotide
When will generic Afamelanotide be available?
Based on the patents and exclusivity the FDA lists today, generic afamelanotide cannot be marketed in the United States before 2033-01-20, when the last listed protection expires.
Patents listed with the FDA
1 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 8334265 | 2033-01-20 | method of use | SCENESSE |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| ODE-270 | 2026-10-08 | Orphan drug exclusivity (7 years) | SCENESSE |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| SCENESSE | Brand (NDA) | CLINUVEL INC | 2019-10-08 | reference listed drug, reference standard |
What a generic Afamelanotide would have to match
Forms and strengths
Implant: 16 mg of afamelanotide as a solid white to off-white, bioresorbable, sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. Implant: 16 mg of afamelanotide .
How it is supplied
SCENESSE (afamelanotide) implant, 16 mg, for subcutaneous administration (NDC 73372-0116-1) is supplied in a Type I amber glass vial sealed with a PTFE coated rubber stopper. Each vial contains one afamelanotide implant and is packaged individually in a cardboard box. SCENESSE implant is a solid white to off-white, bioresorbable and sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. Store in a refrigerator at 2°C, 8°C (36°F-46°F). Protect from light. SCENESSE implants are not supplied with an implantation device for subcutaneous administration [ see Dosage and Administration ].
Storage
Store in a refrigerator at 2°C, 8°C (36°F-46°F). Protect from light. SCENESSE implants are not supplied with an implantation device for subcutaneous administration [ see Dosage and Administration ].
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-05-11.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Bremelanotideprotection runs to November 2033
- Vasopressinprotection runs to January 2035
- Liraglutideprotection runs to January 2037
- Calcitoninno patent or exclusivity listed
- Cetrorelixno patent or exclusivity listed
Frequently asked questions
When will generic Afamelanotide be available?
Based on the patents and exclusivity the FDA lists today, generic afamelanotide cannot be marketed in the United States before 2033-01-20, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
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