Home / Generic availability / Bremelanotide
When will generic Bremelanotide be available?
Based on the patents and exclusivity the FDA lists today, generic bremelanotide cannot be marketed in the United States before 2041-04-29, when the last listed protection expires.
Patents listed with the FDA
4 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10286034 | 2033-11-05 | method of use | VYLEESI (AUTOINJECTOR) |
| 9352013 | 2033-11-05 | method of use | VYLEESI (AUTOINJECTOR) |
| 9700592 | 2033-11-05 | method of use | VYLEESI (AUTOINJECTOR) |
| 11590209 | 2041-04-29 | method of use | VYLEESI (AUTOINJECTOR) |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| VYLEESI (AUTOINJECTOR) | Brand (NDA) | COSETTE PHARMACEUTICALS INC | 2019-06-21 | reference listed drug, reference standard |
What a generic Bremelanotide would have to match
Forms and strengths
Subcutaneous injection: 1.75 mg/0.3 mL clear solution in a single-dose autoinjector. Subcutaneous injection: 1.75 mg/0.3 mL solution. ( 3 )
How it is supplied
VYLEESI (bremelanotide) is supplied as: 1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 0713-0897-06) provided in a carton of 4 autoinjectors (NDC 0713-0897-04), carton of 2 autoinjectors (NDC 0713-0897-02). Storage Store at or below 25°C (77°F). Do not freeze. Protect from light.
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 2025-11-13.
Recalls involving Bremelanotide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding | TX | Class II | 2022-04-05 | Lack of Assurance of Sterility: deviations from Current Good Manufactu |
| Promise Pharmacy, LLC | FL | Class II | 2018-12-17 | Lack of sterility assurance. |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Vasopressinprotection runs to January 2035
- Liraglutideprotection runs to January 2037
- Calcitoninno patent or exclusivity listed
- Cetrorelixno patent or exclusivity listed
- Cosyntropinno patent or exclusivity listed
Frequently asked questions
When will generic Bremelanotide be available?
Based on the patents and exclusivity the FDA lists today, generic bremelanotide cannot be marketed in the United States before 2041-04-29, 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.
Related data
- Bremelanotide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book