Last updated: February 16, 2026
What Is NDC 64980-0663?
NDC 64980-0663 corresponds to Vyleesi (Bremelanotide), a drug approved by the FDA in June 2019. It is used for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is administered via subcutaneous injection and marketed primarily for its sexual desire enhancement effects.
Market Overview
Market Size and Epidemiology
- The target population comprises premenopausal women aged 18-50 with diagnosed HSDD.
- Estimates: Approximately 10-15% of women in this demographic report low sexual desire, with HSDD prevalence around 5%, influencing an estimated addressable market of 4-6 million U.S. women.
- Actual treated population is smaller; clinical estimates suggest around 1-2% of women diagnosed receive treatment annually.
Competitive Landscape
- Vyleesi is the first medication approved specifically for HSDD with a distinct subcutaneous formulation.
- Off-label treatments and non-pharmacological options dominate in practice; no direct oral competitors currently exist.
- Potential pipeline drugs might include oral analogs or alternative therapies, but none are FDA-approved for HSDD as of 2023.
Market Entry Barriers
- Stigma around sexual dysfunction treatments.
- Limited physician familiarity.
- Reimbursement challenges due to cost.
Pricing Strategy and Cost Analysis
Vyleesi Price
- List price (as of 2023): $1,350 per 30-dose box.
- Dosing: 1.75 mg subcutaneous injection administered at least 45 minutes before anticipated sexual activity, up to once per day.
- Cost on a per-dose basis: approx. $45.
Insurance and Reimbursement Dynamics
- Co-pay assistance programs are available.
- Insurance coverage varies; some payers exclude coverage due to cost or classification as a lifestyle or elective therapy.
- Estimated net price after rebates and discounts ranges from $650 to $900 per dose.
Market Projections (2023-2030)
| Year |
Estimated Prescriptions |
Market Penetration |
Revenue (approximate) |
Comments |
| 2023 |
50,000 |
2% of target population |
$67.5 million |
Launch year, slow adoption, initial payer hesitance. |
| 2024 |
100,000 |
4% |
$135 million |
Increased awareness and physician familiarity. |
| 2025 |
200,000 |
8% |
$270 million |
Expanded insurance coverage, inclusion in treatment guidelines. |
| 2026 |
300,000 |
12% |
$405 million |
Growing patient acceptance, direct-to-consumer marketing. |
| 2027 |
400,000 |
16% |
$540 million |
New formulations or partnerships might accelerate growth. |
| 2028 |
500,000 |
20% |
$675 million |
Market saturation begins; potential entry of competitors. |
| 2029 |
600,000 |
24% |
$810 million |
Market plateau, competition increases. |
| 2030 |
700,000 |
28% |
$945 million |
Mature market, stable or slight growth. |
Assumptions: The modeling assumes gradual market penetration, with steady growth driven by increased awareness, coverage expansion, and physician endorsement.
Regulatory and Pricing Considerations
- The drug's high list price invites scrutiny from payers, potentially limiting utilization.
- Favorable coverage will progress with clinical evidence and provider education.
- Future price adjustments may result from manufacturer negotiations, patent litigation, or the development of more affordable competitors.
Key Competitive and Regulatory Risks
- The lack of oral formulations may slow adoption compared to other sexual health drugs.
- Insurance coverage gaps could hinder revenue.
- Public perception and stigma impact demand.
Summary
Vyleesi (bremelanotide) remains the only FDA-approved injectable therapy for HSDD in premenopausal women. Its high list price and insurance reimbursement challenges restrict some access, but the target market's size and increasing awareness suggest sustainable moderate-to-high revenue growth, potentially reaching nearly $1 billion by 2030.
Key Takeaways
- The drug targets a niche but sizable market segment with unmet needs.
- Market penetration is expected to grow modestly, driven by insurance coverage and provider familiarity.
- Price sensitivity and reimbursement policies heavily influence net revenue.
- Competition may emerge through oral alternatives or new therapies, impacting long-term market dynamics.
FAQs
-
What is the primary market for NDC 64980-0663?
- Premenopausal women with diagnosed HSDD seeking pharmacological treatment.
-
How does the drug’s pricing compare to similar therapies?
- At approximately $1,350 per box, it is among the higher-priced treatments for sexual health, with no direct oral competitors currently available.
-
What are the main barriers to market expansion?
- Insurance coverage restrictions, social stigma, and limited physician awareness.
-
What is the outlook for future price adjustments?
- Potential price reductions could result from negotiations, increased competition, or efforts to improve affordability.
-
Is there potential for new competitors?
- Yes; oral or alternative therapies for HSDD are in development but have not yet received FDA approval.
Sources
[1] U.S. Food & Drug Administration. Vyleesi (bremelanotide) approval announcement, 2019.
[2] IQVIA. Prescription Trends for HSDD treatments, 2021-2023.
[3] Evaluate Pharma. Forecasts for specialty pharmaceuticals, 2023-2030.
[4] CMS & Aetna reimbursement policies, 2023.
[5] Prescription Drug Prices, SSR Health.
(Numbers and projections are estimates based on available data and market trends as of early 2023.)
