Last updated: February 20, 2026
What is NDC 31722-0413?
The National Drug Code (NDC) 31722-0413 refers to Vyleesi (bremelanotide), a drug approved by the FDA in June 2019 for the treatment of acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is administered via subcutaneous injection.
Market Landscape
Indication and Patient Population
Vyleesi targets premenopausal women suffering from HSDD, a condition characterized by a persistent or recurrent deficiency in sexual desire causing distress. The estimated patient population in the United States is approximately 4-6 million women, based on prevalence figures from the Journal of Sexual Medicine (fluctuations depend on diagnostic criteria).
Existing Treatments
No direct line of competing drugs for HSDD exists; off-label treatments like testosterone therapy are prescribed, but they lack FDA approval for this indication. Vyleesi occupies a niche with limited direct competition.
Market Penetration and Adoption
As of 2023, Vyleesi remains in early adoption phase due to:
- High cost (~$20,000 per treatment course for 8 doses)
- Limited awareness among patients and clinicians
- Reimbursement challenges, with insurance coverage variable
Sales Data
Initial quarterly sales figures recorded approximately $3 million globally by Q4 2022. Sales growth depends upon increased prescriber uptake and insurance reimbursements. The drug's market share remains below 2% of the total potential patient population.
Price Projections and Revenue Forecast
Market Penetration Assumptions
- Year 1 (2023): 3-5% of eligible patients
- Year 2 (2024): 8-10%
- Year 3 (2025): 15-20%
Revenue Estimates
| Year |
Patients Treated (millions) |
Market Penetration |
Annual Revenue (USD millions) |
| 2023 |
0.12-0.30 |
3-5% |
$75-$150 (based on ~$20,000 per course) |
| 2024 |
0.32-0.60 |
8-10% |
$300-$600 |
| 2025 |
0.88-1.3 |
15-20% |
$1,700-$2,600 |
Price Erosion Factors
- Payer resistance leading to potential discounts
- Competition from future therapies or biosimilars
- Pricing pressure with increased market penetration
Cost Considerations
- Manufacturing costs approximated at 30-40% of wholesale price
- Distribution and marketing costs added on
Competitor Analysis
- No direct competitor currently in the US market
- Potential entrants include biosimilar or novel therapies aimed at similar or overlapping indications
- Competitive landscape might alter projections if new drugs gain approval before 2025
Regulatory and Policy Impact
- Reimbursement policies heavily influence sales potential
- Medicaid and private insurers may impose restrictions, affecting net prices
- Price negotiations could reduce effective revenue per treatment course by 10-30%
Summary
Vyleesi’s market is nascent, with growth constrained by awareness, insurance coverage, and high cost. Revenue projections suggest sales could reach approximately $2.6 billion globally by 2025 if market penetration targets are met and reimbursement policies are favorable.
Key Takeaways
- The marketed product, NDC 31722-0413 (Vyleesi), targets a niche patient group with limited competition.
- Initial adoption is slow; significant growth hinges on expanded awareness and insurance reimbursement.
- Price projections suggest revenues could significantly increase, potentially reaching multi-billion dollar levels by 2025.
- Cost and reimbursement pressures will influence actual sales and net revenues.
FAQs
1. What factors could accelerate Vyleesi's market penetration?
Enhanced physician awareness, improved insurance coverage, and lower out-of-pocket costs could raise adoption rates.
2. How does the cost impact patient access?
High treatment cost may limit access unless insurance provides substantial coverage or price reductions occur.
3. Are there any upcoming competitors?
No approved direct competitors. Future entrants could shift market dynamics.
4. What are meaningful barriers to market expansion?
Reimbursement challenges, safety concerns, and limited patient awareness.
5. How do global markets differ from the US in this context?
Other countries may face different regulatory pathways and reimbursement models, impacting sales potential.
References
- U.S. Food and Drug Administration. (2019). FDA approves Vyleesi to treat hypoactive sexual desire disorder.
- Market research reports on HSDD and female sexual health market, 2022–2023.
- IMS Health data, Q4 2022 sales figures.
- prevalence and epidemiology data from the Journal of Sexual Medicine (2020).
