Skip to main content
New — The Peptide Dictionary: 128 terms, explained simply
New guide — NAD+ for Anti-Aging: What the Science Says
New guide — GHK-Cu: the copper peptide for your skin
Not sure where to start? — A 60-second quiz points you to the path that fits your goal
New explainer — Semaglutide: what the research says, made simple
Browse — Peptide guides, made simple
New — The Peptide Dictionary: 128 terms, explained simply
New guide — NAD+ for Anti-Aging: What the Science Says
New guide — GHK-Cu: the copper peptide for your skin
Not sure where to start? — A 60-second quiz points you to the path that fits your goal
New explainer — Semaglutide: what the research says, made simple
Browse — Peptide guides, made simple
Easy-to-follow guides
Independent reviews
Vetted providers
Free to read

Home / Generic availability / Setmelanotide

FDA Orange Book · updated 2026-09-23

When will generic Setmelanotide be available?

Under patent or exclusivity

Based on the patents and exclusivity the FDA lists today, generic setmelanotide cannot be marketed in the United States before 2034-07-04, when the last listed protection expires.

2034-07-04
Last protection expires
3
Patents listed
6
Exclusivity records
0
Generics waiting

Patents listed with the FDA

3 unexpired or current listing(s).

PatentExpiresCoversProduct
94581952027-10-13drug substance, drug productIMCIVREE
80394352032-08-21drug substance, drug productIMCIVREE
111298692034-07-04drug productIMCIVREE

FDA exclusivity

Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.

CodeExpiresWhat it isProduct
ODE-3362027-11-25Orphan drug exclusivity (7 years)IMCIVREE
NPP2027-12-20New patient populationIMCIVREE
I-9872029-03-19New indication (3 years)IMCIVREE
ODE-4022029-06-16Orphan drug exclusivity (7 years)IMCIVREE
ODE-5082031-12-20Orphan drug exclusivity (7 years)IMCIVREE
ODE-5092031-12-20Orphan drug exclusivity (7 years)IMCIVREE

Approved products

ProductTypeApplicantApproved
IMCIVREEBrand (NDA)RHYTHM PHARMACEUTICALS INC2020-11-25reference listed drug, reference standard
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

Frequently asked questions

When will generic Setmelanotide be available?

Based on the patents and exclusivity the FDA lists today, generic setmelanotide cannot be marketed in the United States before 2034-07-04, 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 2026-09-23. 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.