Last updated: February 24, 2026
What Is the Drug with NDC 70677-1024?
The drug designated with NDC 70677-1024 is Vyleesi (bremelanotide). Approved by the FDA in June 2019, Vyleesi is indicated for the treatment of acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is administered via subcutaneous injection, with dosing advised before anticipated sexual activity.
Market Landscape
Approved Indications and Competition
Vyleesi operates within the female sexual dysfunction (FSD) treatment segment, which includes therapies like flibanserin (Addyi). The key features are:
- Indication: HSDD in premenopausal women
- Administration: Subcutaneous injection, typically 45 minutes before sexual activity
- Market Size: Estimated at approximately 10 million women affected by HSDD in the U.S. (based on peer-reviewed epidemiological data)
Market Penetration and Adoption
Vyleesi's adoption has been limited by:
- Physician awareness: Initial low prescribing rates post-approval
- Reimbursement barriers: High out-of-pocket costs for patients, due to insurance coverage variability
- Patient perception: Limited awareness about treatment options for HSDD
Entry Barriers and Competitive Factors
- The complexity of diagnosis and patient stigmatization
- The necessity for out-of-pocket payment, as insurance coverage is inconsistent
- Competition from non-pharmacological interventions and psychological therapies
Market Size and Growth Projections
- Current market value: Approximate U.S. market at $50 million in 2022
- Projected growth rate: 10% annually over the next five years, driven by increased physician education and insurance coverage expansion
- Potential market expansion: Limited to premenopausal women with HSDD, with some researchers considering off-label uses
Price Analysis and Projections
Current Pricing
- Per-dose price: Approximate retail price of $850 to $950 per injection
- Insurance coverage: Variable; patients often face significant co-pays
- Average net price post-insurance: Estimated at $400 to $600 per dose
Pricing Trends
- Historical trends: Price stability since launch, with slight reductions for bulk purchasing
- Market pressures: Payers are negotiating for lower prices and greater formulary access
- Manufacturers' response: Potential discounts or value-based pricing negotiations, especially if competitors emerge
Future Price Projections
- Short-term (1-2 years): Stable pricing at around $900 per dose, constrained by manufacturing and distribution costs
- Medium-term (3-5 years): Possible price reduction to $700-$800 per dose if payer negotiations succeed and competition increases
- Long-term (5+ years): Price could decline further to $600-$700 if biosimilars or generics enter the market, or if new therapies with similar efficacy reduce demand
Regulatory and Policy Impacts
- Payer policies: Incremental coverage expansion could lower patient costs
- Legislation: Potential legislation addressing access for sexual health medications might influence pricing
- Reimbursement Trends: Growing emphasis on value-based pricing could pressure manufacturers to lower prices
Competitive and Innovation Opportunities
- Development of oral or longer-acting formulations
- Biosimilar or generic versions post-patent expiration
- Broader indications, such as general female libido issues, to expand market size
Summary
Vyleesi’s market remains limited by reimbursement issues, physician awareness, and patient acceptance. Prices are stable currently, around $900 per dose, with a potential decline to $600-$700 over the next five years driven by payor negotiations and market entry of competitors. The total market value in the U.S. is approximately $50 million, with prospects for steady growth conditioned on increased awareness and coverage.
Key Takeaways
- NDC 70677-1024 corresponds to Vyleesi, approved for HSDD in premenopausal women.
- Market size is approximately $50 million in the U.S., with growth prospects of 10% annually.
- Current price per dose: around $900, with net prices between $400-$600.
- Future pricing could decrease to $600-$700 if competitive pressures increase.
- Market entry barriers include insurance reimbursement and patient awareness.
FAQs
1. What is the primary competitor to Vyleesi?
Flibanserin (Addyi) is the primary competitor, approved for similar indications with oral bioavailability.
2. How does reimbursement affect Vyleesi’s market?
Limited insurance coverage leads to high out-of-pocket costs, impeding patient access and limiting market penetration.
3. Are biosimilars likely to appear for Vyleesi?
Patent expiration and market dynamics could eventually lead to biosimilars, potentially reducing prices.
4. What is the typical patient profile for Vyleesi?
Premenopausal women diagnosed with acquired, generalized HSDD who prefer injectable therapy.
5. Could the market expand beyond HSDD?
Possible if new indications are approved, but current regulatory approval is limited to HSDD.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Vyleesi to treat hypoactive sexual desire disorder in premenopausal women. Retrieved from https://www.fda.gov
[2] IQVIA. (2022). U.S. prescription drug market data. Retrieved from https://www.iqvia.com
[3] DataMonitor. (2023). Female sexual dysfunction market analysis report. Retrieved from https://www.datamonitor.com
[4] Centers for Disease Control and Prevention. (2021). Female sexual health statistics. Retrieved from https://www.cdc.gov
