Last updated: February 28, 2026
What is the Drug Corresponding to NDC 50458-0645?
The National Drug Code (NDC) 50458-0645 identifies Vyleesi (bremelanotide). Approved by the FDA in June 2019, Vyleesi is a melanocortin receptor agonist used to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Market Size and Adoption
Target Population
- Estimated 5 million premenopausal women in the US with HSDD.
- Treatment adoption rates remain modest; estimates suggest 10-15% initiation within the first year.
- Growth driven by increased awareness, approval, and insurance coverage.
Competition
- Addyi (flibanserin) is the primary alternative for female sexual desire disorder.
- Estimates indicate total sales for HSDD treatments, primarily Addyi, reached approximately $150 million in 2022.
Market Penetration Factors
- Prescription barriers linked to safety profile concerns.
- Administration route favors patient preference over oral medications.
- Insurance coverage limits could hinder widespread use.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
- List price for Vyleesi averages approximately $1,150 per month (product pack includes two doses).
- Similar to Addyi, which ranges from $400 to $800 per month but varies with pharmacy discounts and insurance.
Pricing Strategy
- Launch pricing aligned with Addyi, slightly higher due to administration route and perceived efficacy.
- Indications for use are limited to episodic administration, influencing price elasticity.
Reimbursement Landscape
- Insurers often require prior authorization.
- Cost-sharing may vary; patients could face copayments from $20 to $60 per prescription.
Price Projections
| Year |
Estimated WAC |
Major Influences |
Notes |
| 2023 |
$1,150 |
Initial launch, limited awareness |
High inflation in drug costs impacts list prices |
| 2024 |
$1,200 |
Increased competition from generics or biosimilars? |
No generic available yet; possible price stabilization or slight increase |
| 2025 |
$1,250 |
Increased adoption and broader insurance coverage |
Market growth may exert upward pricing pressure |
- Price increases will likely be constrained by payer pressures and market saturation.
- Competitive pricing with Addyi and potential biosimilar entries could temper elevation.
Regulatory and Market Dynamics Impacting Price
- Patent and exclusivity: Patent protections extend until at least 2030, preventing generic entry.
- Reimbursement policies: Insurance coverage expansion could boost sales but might pressure prices downward.
- Market penetration: Slow adoption may limit revenue growth, influencing pricing strategies.
Key Drivers for Future Market Development
- Physician and patient awareness campaigns.
- New indications or expanded use cases.
- Insurance policy shifts toward broader coverage.
- Potential biosimilar entries post-patent expiry.
Summary
The current price point of approximately $1,150 WAC per month situates Vyleesi as a premium-priced treatment within the female HSDD segment. Sales are modest but expected to grow gradually due to increased awareness and insurance coverage. Price escalation is likely to remain moderate, influenced by competitive pressures and payer negotiations.
Key Takeaways
- Vyleesi (NDC 50458-0645) targets a niche market for HSDD in premenopausal women.
- The drug's pricing is consistent with similar therapies like Addyi but remains under pressure from potential future biosimilar competition.
- Market adoption will depend heavily on insurance reimbursement and physician prescribing behaviors.
- Total revenue potential remains limited unless broader indications or increased acceptance occur.
- Price projections between 2023-2025 suggest incremental increases, contingent on market dynamics and competitive landscape.
FAQs
-
What factors influence Vyleesi's retail price?
Insurance reimbursement rates, market penetration, competitive pricing, and manufacturing costs.
-
How does Vyleesi's pricing compare to Addyi?
Slightly higher, approximately $1,150/month versus $400–$800 for Addyi, reflecting administration preferences and efficacy perceptions.
-
What are the main barriers to wider adoption?
Prescription hesitancy due to safety concerns, insurance coverage limitations, and patient awareness.
-
Could biosimilars impact Vyleesi's pricing?
Yes. Biosimilars could introduce price competition after patent expiry, likely reducing costs.
-
What is the potential for revenue growth beyond 2025?
Growth depends on market expansion, off-label uses, and insurance approval, but overall market size remains limited.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Vyleesi to treat low sexual desire in premenopausal women. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-vyleesi-treat-low-sexual-desire-premenopausal-women
[2] IMS Health (2022). Pharmaceutical Market and Pricing Data.
[3] Market Research Future. (2022). Female Sexual Dysfunction Market Forecast.
