Last updated: February 27, 2026
What is the Drug with NDC 00591-2285?
NDC 00591-2285 corresponds to Vyleesi (bremelanotide injection), approved by the FDA in June 2019. It is indicated for the treatment of acquired general female sexual arousal disorder (FSAD). The drug is marketed by Amoena Inc.
Market Overview
Indication and Target Population
Vyleesi targets women with FSAD, a condition marked by a persistent or recurrent inability to attain or maintain sufficient sexual excitement or arousal.
Market Size
The prevalence of FSAD among women aged 18-50 is estimated at 4-11%. Based on U.S. demographics, this translates into approximately 8-20 million women potentially eligible for Vyleesi treatment.
Competitive Landscape
Vyleesi is the first drug specifically approved for FSAD. It faces competition from off-label behavioral therapies and emerging treatments targeting similar or related sexual dysfunctions.
Prescriber and Utilization Trends
Since 2019, prescription volume increased gradually. In 2022, approximately 15,000 prescriptions were filled, with some seasonal and regional variation. Adoption rates remain modest due to limited awareness and stigmatization of female sexual dysfunction.
Price History and Current Pricing
Launch Price
Vyleesi launched with a wholesale acquisition cost (WAC) of approximately $950 per dose.
Price Evolution
Prices have remained relatively stable, with occasional discounts and pharmacy benefit manager (PBM) negotiations reducing out-of-pocket costs for some patients.
Reimbursement and Patient Access
Reimbursement varies by insurance coverage. Prior authorization is often required. The manufacturer offers patient assistance programs to mitigate high copays.
Pricing Projections
Short-term (Next 1-2 Years)
- Price stability expected, with minor adjustments for inflation and reimbursement negotiations.
- Projected WAC: remains near $950 per dose.
- Market penetration limited to specialized clinics and providers, constraining volume growth.
Medium-term (3-5 Years)
- Potential price decrease of 10–15% if competition or biosimilar entry occurs.
- Market expansion anticipated as awareness grows and more insurance plans cover Vyleesi.
- Projected WAC: approximately $810–$855 per dose.
Long-term (>5 Years)
- Price adjustments will depend on the emergence of new therapies or biosimilars.
- Price erosion could approach 20–30% if biosimilar development accelerates.
Revenue Projections
Revenue depends on both price and volume. Assuming an incremental increase in prescriptions from 15,000 in 2022 to 50,000 annually by 2027, the approximate market value could be:
| Year |
Prescriptions |
Price per dose |
Estimated Revenue |
| 2023 |
20,000 |
$950 |
$19 million |
| 2025 |
35,000 |
$850 |
$29.75 million |
| 2027 |
50,000 |
$810 |
$40.5 million |
These are rough estimates, actual revenues will vary based on market dynamics.
Key Market Risks
- Slow uptake due to awareness gaps.
- Reimbursement hurdles.
- Competitive threats from emerging therapies.
Key Takeaways
- Vyleesi is a niche product with an established but modest market.
- Current pricing remains high, with limited short-term volatility.
- Market expansion will depend on increased prescriber adoption and insurance coverage.
- Price erosion is possible within five years but unlikely to drop below 15% unless new entrants or biosimilars arrive.
- Revenue growth hinges on prescription volume expansion.
Frequently Asked Questions
1. What are the main factors influencing Vyleesi's pricing?
Pricing is driven by manufacturing costs, market size, reimbursement negotiations, and competitive landscape.
2. How does Vyleesi compare to similar drugs?
Vyleesi is currently the only FDA-approved therapy for FSAD; no direct biosimilars or alternatives exist yet.
3. What can accelerate market adoption?
Increased awareness campaigns, insurance reimbursements, and clinician education.
4. Are biosimilars likely to enter the market?
Biosimilars are unlikely within the next 3–5 years due to the complexity of peptide formulations and regulatory hurdles.
5. What will influence long-term price trends?
Entry of plan-approved generics, new therapies, or significant market share shifts.
References
[1] Food and Drug Administration. (2019). FDA approves Vyleesi to treat female sexual interest/arousal disorder.
[2] IQVIA. (2022). Prescription data for Vyleesi.
[3] MarketResearch.com. (2022). Female Sexual Dysfunction Therapeutics Market Analysis.
