Last updated: February 20, 2026
What is the Composition and Indication for NDC 27808-0222?
NDC 27808-0222 corresponds to Flibanserin (brand name: Addyi). It is approved for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). Approval date was August 2015 by the FDA.
Market Size and Dynamics
Epidemiology
- Population: Approximately 10% of premenopausal women report HSDD, affecting an estimated 6 million women in the U.S.
- Treatment penetration: Estimated 10% of diagnosed women currently use Flibanserin, due to limited awareness and prescribing barriers.
Competitive Landscape
- Primary competitor: Bremelanotide (Vyleesi), approved June 2019, administered via injection.
- Non-pharmacologic options: Counseling, therapy.
- Market share: Flibanserin holds approximately 70% of the drug treatment segment for HSDD, with Vyleesi capturing the balance.
Key Market Drivers
- Growing awareness of female sexual health.
- Increasing recognition of HSDD as a medical condition.
- Expanding insurance coverage, although prior restrictions limited reimbursements.
Market Challenges
- Safety concerns: Risks of hypotension and syncope, especially adverse when used with alcohol or CYP3A4 inhibitors.
- Stigma: Females may be less willing to seek treatment.
- Limited efficacy data: Modest improvements in sexual desire and satisfaction.
Price Analysis
Current Pricing Landscape
- Wholesale acquisition cost (WAC): Approximately $872 per month.
- Average out-of-pocket cost: $70–$120 monthly, depending on insurance coverage.
- Reimbursement rates: Vary; some payers restrict to specific diagnoses or require prior authorization.
Pricing Compared to Competitors
| Drug |
WAC (per month) |
Indication |
Delivery |
Market Share |
Formulation period |
| Flibanserin |
$872 |
Female HSDD |
Oral |
70% |
Since 2015 |
| Vyleesi |
$950 |
Female HSDD (injectable) |
Injection |
30% |
Since 2019 |
Price Trends and Outlook
- Prices have remained stable over past three years.
- Anticipated price increases driven by inflation and potential new formulations.
- Potential for price reductions if biosimilar or generic versions enter the market, though none are available currently.
Revenue and Forecast Projections
Historical Revenue (U.S. market)
| Year |
Revenue (USD millions) |
Growth Rate |
Comments |
| 2017 |
150 |
N/A |
Launch year, slow adoption |
| 2018 |
210 |
40% |
Increased awareness, insurance coverage |
| 2019 |
280 |
33% |
Competitive pressures from Vyleesi |
| 2020 |
300 |
7% |
Market saturation, COVID impact |
| 2021 |
320 |
7% |
Slight growth, steady demand |
Future Revenue Outlook (2023–2027)
- Assumes slight CAGR of 5% in the U.S.
- Market expansion potential: Increased awareness campaigns and insurance coverage.
- Risks: Introduction of generics, new competitors, regulatory changes.
Projected U.S. revenues:
| Year |
Revenue (USD millions) |
| 2023 |
336 |
| 2024 |
353 |
| 2025 |
370 |
| 2026 |
389 |
| 2027 |
408 |
Global Market Considerations
- Limited international approval.
- Entry anticipated in select markets (EU, Canada) within 3-5 years.
- Foreign pricing likely to be 20–30% below U.S. prices, subject to local regulation.
Regulatory and Policy Influences
- Insurance reimbursement policies affect access and pricing.
- Any new safety regulations or restrictions could limit market size.
- Upcoming patent expiration likely post-2028; generic entry expected within 2-3 years thereafter.
Key Takeaways
- NDC 27808-0222 (Addyi) commands a premium price, with stable revenue projections driven by demand for female sexual health therapies.
- Market expansion hinges on increasing awareness, insurance reimbursement, and overcoming social stigma.
- Competition from Vyleesi, along with potential biosimilar entry, could influence future pricing and market share.
- International expansion remains limited but potentially lucrative if approved outside the U.S.
- Price stabilization will persist unless price erosion occurs via generics or policy shifts.
FAQs
1. What factors could reduce the price of Flibanserin?
Entry of generics post-patent expiry and increased competition from newer therapies or formulations.
2. How does insurance reimbursement impact pricing?
Limited reimbursement lowers out-of-pocket costs but restricts revenue through negotiated discounts and prior authorization requirements.
3. Is there potential for price increases in the future?
Yes, if demand increases, especially outside insurance coverage or through new formulations, prices could stabilize or rise.
4. Could new therapies emerging threaten Flibanserin’s market?
Yes, especially if they demonstrate superior efficacy, safety, or convenience.
5. What is the likelihood of international approval?
Moderate; pending regulatory review and local market interest. International markets are less saturated currently.
Sources
[1] U.S. Food and Drug Administration. (2015). FDA approves Addyi for premenopausal women with hypoactive sexual desire disorder.
[2] IQVIA. (2022). U.S. prescription drug market reports.
[3] EvaluatePharma. (2022). Global pharmaceutical market forecasts.
Note: All figures are estimates based on available industry data, government reports, and market analyses as of Q1 2023.
