Last updated: February 27, 2026
What is NDC 65649-0150?
NDC 65649-0150 corresponds to Vyleesi (bremelanotide), a drug approved by the FDA for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. It is administered via subcutaneous injection and marketed by Palatin Technologies. Approval was granted in June 2019.
Market Size and Demand Dynamics
Target Population
- Prevalence of HSDD: Affects approximately 10-15% of premenopausal women in the U.S., estimated at 15-23 million women.
- Diagnosed Cases: Under 2% received prescription treatment, indicating significant unmet need.
- Treatment Initiation Estimates: Based on early prescription trends, roughly 150,000 to 250,000 women could be treated annually in the U.S.
Competitive Landscape
- Direct Competition: Few FDA-approved medications for HSDD; off-label treatments include off-market testosterone therapies.
- Indirect Competition: Non-pharmacologic therapies such as counseling, lifestyle changes.
- Market Access: Reimbursement challenges due to high cost and safety profile concerns.
Market Trends
- Increasing awareness of female sexual health issues.
- Growing acceptance of pharmacologic treatments.
- Potential expansions into postmenopausal or male populations are under evaluation but not yet approved.
Pricing Analysis
Current Pricing Overview
- List Price: Estimated at roughly $1,490 per injection (per FDA label), based on wholesale acquisition costs (WAC).
- Treatment Regimen: Once monthly injections for three months, typically costing approximately $4,470 per course.
- Insurance & Reimbursement: Historically, coverage has been limited; patient copays tend to range from $150 to $300 per injection.
Price Compared to Similar Therapeutics
| Drug |
Indication |
Price per Dose |
Dosing Frequency |
Market Penetration |
| Vyleesi (bremelanotide) |
Female HSDD |
$1,490 |
Monthly (once) |
Low |
| Addyi (flibanserin) |
Female HSDD |
$1,500 (monthly) |
Daily |
Moderate |
| Testosterone (off-label) |
Female & Male hypoactive desire |
Varies (~$150/month) |
Daily or weekly |
Off-label |
Price Projection Scenarios
Base Case (Moderate Growth):
- Market Penetration: 10% of estimated treated population within 5 years (~75,000 women).
- Average Treatment Cost: $4,470 per course.
- Annual Revenue: ~$336 million.
Optimistic Case (High Adoption):
- Market Penetration: 20% within 5 years (~150,000 women).
- Average Treatment Cost: Maintains current levels, potentially decreasing to ~$4,000 with bulk pricing.
- Annual Revenue: ~$600 million.
Pessimistic Case (Slow Adoption, Reimbursement Barriers):
- Market Penetration: 2-5% (~7,500–18,750 women).
- Annual Revenue: <$60 million.
Price Erosion Factors
- Potential for generic competition is unlikely due to the novel mechanism and patent protections.
- Price reductions could occur with increased competition or formulary inclusion pressure.
- Manufacturer incentives could trigger discounts to campaigned prescribers.
Patent and Regulatory Outlook
- Patent Expiry: Patents extending into at least 2030, protecting exclusivity.
- Orphan Drug Status: Not granted; market is considered non-orphan but with high unmet needs.
- Regulatory Risks: Minor, related to safety signals; no major hurdles projected.
Key Takeaways
- The market for NDC 65649-0150 is relatively limited but underserved.
- Current list pricing is high, supported by limited competition and high treatment costs.
- Revenue projections range from <$60 million to over $600 million annually, depending on market penetration.
- Price declines may be limited by patent protections but could be influenced by payer negotiations.
FAQs
Q1: What are the primary factors influencing Vyleesi’s market penetration?
Patient awareness, reimbursement policies, healthcare provider acceptance, and safety profile.
Q2: How does Vyleesi’s price compare internationally?
Most countries pay significantly less due to pricing regulations; exact figures vary by country.
Q3: Are there upcoming competitors or pipeline candidates?
Currently, few pipeline candidates are FDA-approved; competition remains limited.
Q4: Will insurance coverage expand, affecting sales?
Yes, as more providers and payers recognize the treatment’s value, coverage is likely to improve.
Q5: What is the potential for off-label use of similar drugs?
Off-label use of testosterone exists but is not officially approved for HSDD and carries safety considerations.
References
- FDA. (2019). Vyleesi approval letter.
- Palatin Technologies. (2023). Vyleesi prescribing information.
- IQVIA. (2022). U.S. prescription trends for female sexual dysfunction drugs.
- Medical Economics. (2022). Reimbursement landscape for female sexual health therapies.
- ClinicalTrials.gov. (2023). Pipeline and ongoing studies related to female sexual desire disorders.
