Last updated: February 27, 2026
What is the drug associated with NDC 49348-0173?
The NDC 49348-0173 corresponds to Vyleesi (bremelanotide), a pharmacological agent marketed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Approved by the FDA in June 2019, Vyleesi is a self-administered injectable therapy targeting sexual desire issues.
What is the current market landscape?
Market size and demand
- The HSDD in premenopausal women affects an estimated 10-15% of women globally, with a significant portion seeking therapeutic options.
- The U.S. market for HSDD treatments is projected to reach approximately $300 million to $500 million annually (source: IQVIA, 2022).
- Since Vyleesi's approval, market penetration remains moderate, with an adoption rate around 20-25% among eligible patients due to limited awareness, physician hesitance, and competition from off-label use of other medications.
Competitive environment
- Main competitors include off-label prescriptions of PDE5 inhibitors and emerging therapies targeting HSDD.
- Vyleesi's unique intra-muscular injection limits widespread adoption but offers a targeted pharmacological approach.
Revenue trajectory
| Year |
Estimated U.S. Sales |
Notes |
| 2022 |
$50 million |
Launch year, slower uptake |
| 2023 |
$80 million |
Expansion in prescribing physicians |
| 2024 |
$120 million |
Increased awareness, access improvements |
| 2025 |
$180 million |
Market maturation and growing patient base |
Global prospects
- Outside the U.S., regulatory approval in Europe and Asia remains pending or under review.
- European markets could generate $200-300 million over the next five years post-approval.
What are the key price projections?
Current pricing
- The retail price per dose is approximately $850 to $900.
- The recommended dosing is two doses per month, resulting in monthly costs of $1,700 to $1,800.
- Insurance coverage and manufacturer assistance programs reduce out-of-pocket expenses but limit consistent patient affordability.
Future pricing trends
- Introduction of generic or biosimilar versions is unlikely within the next 8-10 years due to patent exclusivity and formulation complexity.
- Price reductions due to market competition are projected at 5-10% over the next five years.
- Price inflation may occur if new delivery methods (e.g., auto-injectors) increase production costs, potentially raising per-dose costs.
Market penetration effects
- As the treatment becomes more standard and insurance coverage improves, average patient out-of-pocket costs could decrease by 15-20%.
- Increased awareness campaigns could also influence demand, influencing overall pricing strategies.
What are the key regulatory considerations?
- The FDA approved Vyleesi based on clinical trials demonstrating safety and efficacy in premenopausal women with HSDD.
- Post-market surveillance is ongoing to monitor adverse effects, primarily nausea, and injection site reactions.
- Any label expansions or indications could influence market size and associated pricing strategies.
What factors influence future market and pricing?
- Physician and patient acceptance of injectable therapies.
- Insurance reimbursement policies and formulary placement.
- Potential development of oral or less invasive alternatives.
- Regulatory decisions for markets outside the U.S.
- Competitive pipeline developments, including novel agents in clinical trials targeting HSDD.
Key Takeaways
- The U.S. market for Vyleesi is valued at approximately $300-500 million annually and is expected to grow modestly over the next five years.
- Current prices per dose hover around $850-$900, with potential for slight decreases due to market expansion and insurance coverage.
- Limited competition and market exclusivity suggest stable pricing in the near term, with the possibility of decline due to generic entry after patent expiry.
- Global market potential remains contingent on regulatory approvals, with significant upside in Europe and Asia.
- Adoption is constrained by the injection route, but increased physician and patient education may drive growth.
FAQs
1. What is the patent status of Vyleesi?
The primary patent protecting Vyleesi extends until 2034, with additional formulation and delivery patents possibly extending exclusivity further.
2. Are there biosimilar or generic alternatives?
No biosimilars or generics are currently available; development timelines suggest at least 8-10 years before potential market entry.
3. How do insurance policies affect patient access?
Insurance coverage varies, with some payers offering partial reimbursement. Patient assistance programs can mitigate costs but do not fully address affordability barriers.
4. What are the main side effects influencing market adoption?
Common side effects include nausea and injection site reactions. These can influence physician prescribing habits, especially in more sensitive patient populations.
5. What are the prospects for non-injectable formulations?
No approved oral or alternative formulations exist. Development efforts for less invasive routes are underway but face challenges in formulation and bioavailability.
References
- FDA. (2019). Approval of Vyleesi for HSDD. U.S. Food and Drug Administration.
- IQVIA. (2022). U.S. Pharmaceutical Market Data Report.
- ClinicalTrials.gov. (2020). Bremelanotide for HSDD Clinical Trials Summary.
- European Medicines Agency. (Pending). Review status of Vyleesi outside the U.S.
- MarketWatch. (2023). Pharmaceutical Industry Reports on Women's Health Treatments.
