Prescription medicine
Bremelanotide Brand names: Vyleesi; first approved as Vyleesi (Autoinjector)
Bremelanotide (Vyleesi) 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 bremelanotide FDA label on DailyMed (effective November 13, 2025, Cosette Pharmaceuticals, Inc.); the NDA 210557 record on Drugs@FDA; every bremelanotide label on DailyMed.
Highlights of the record
FDA label of November 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance.
Forms and strengths
- 1.75 mg/.3ml
Injection.
On the market
- Earliest approval on file
- June 21, 2019 Vyleesi (Autoinjector), Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 29, 2041 Vyleesi 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)
- 0 since 2018 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 1,004 through July 30, 2026
What is bremelanotide used for?
From the label: indications and usageVYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. […]
FDA pharmacologic class: Melanocortin Receptor Agonist.
Source: FDA drug label (Vyleesi), Cosette Pharmaceuticals, Inc., effective November 13, 2025 (SPL set f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf), via openFDA; the full label on DailyMed
Is there a generic for bremelanotide (Vyleesi)?
No generic bremelanotide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Vyleesi injection, the last expiring on April 29, 2041. 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
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has bremelanotide been recalled?
The FDA's Enforcement Report lists 1 recall naming bremelanotide since 2018: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of bremelanotide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 17, 2018 | Class II | Promise Pharmacy, LLC not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bremelanotide label say about other medicines?
The bremelanotide label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Indomethacin | drug interactions | In addition, patients should consider discontinuing VYLEESI if there is a delayed drug effect of concomitant oral medications when a quick onset of drug effect is desired (e.g. drugs for pain relief such as indomethacin). |
| Naltrexone | drug interactions | DRUG INTERACTIONS VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. ( 7.1 ) VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; … |
Source: FDA drug label (Vyleesi), Cosette Pharmaceuticals, Inc., effective November 13, 2025 (SPL set f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf), via openFDA; the full label on DailyMed
What do FAERS reports show for bremelanotide?
The FDA Adverse Event Reporting System holds 1,004 reports that list bremelanotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 6 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Bremelanotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other