Last updated: February 21, 2026
What is the drug associated with NDC 50268-0196?
NDC 50268-0196 corresponds to Fezolinetant, a selective neurokinin-3 receptor antagonist. It is developed primarily for the treatment of menopausal hot flashes and other vasomotor symptoms associated with menopause.
Current Development Status and Regulatory Milestones
- Clinical Phase: Fezolinetant is in Phase 3 clinical trials, with completed Phase 2 studies demonstrating efficacy and safety.
- Regulatory Submission: Expected submission for FDA approval occurred in late 2022 or early 2023.
- Market Authorization: Pending FDA approval, likely clearance in 2023 or 2024.
Market Landscape
Target Patient Population
- U.S. menopausal women: Approx. 50 million women aged 45-54.
- Vasomotor symptoms prevalence: Estimated at 70%, with around 25 million women experiencing moderate to severe hot flashes.
- Growth factors: Increasing focus on non-hormonal treatment options driven by concerns over hormone therapy risks, aging population, and patient preference shifts.
Competitive Environment
| Company |
Drug |
Approval Status |
Market Share (2023 estimate) |
Key Features |
| Brigham and Women's Hospital (developing) |
Fezolinetant |
Pending FDA approval |
N/A |
Non-hormonal, oral, targeted for hot flashes |
| Anamed and other startups |
Other NK3 antagonists |
Preclinical/early clinical |
N/A |
Focus on vasomotor symptom relief |
| Hormone therapies (e.g., Tamoxifen, Clonidine) |
Hormonal agents and off-label uses |
Widely used |
70-80% of symptomatic women |
Established but with safety concerns |
Market Size and Revenue Potential
According to IQVIA data, the menopause market in the U.S. reached an estimated $3-4 billion in 2022, with potential for 40% growth in the next five years due to:
- Increasing number of eligible patients.
- Strong demand for non-hormonal alternatives.
- Expanding indications for vasomotor symptom management.
Pricing Considerations
Currently, hormone therapy costs range from $15-50 per month depending on formulation and insurance coverage. Non-hormonal drugs typically aim for a similar price point initially.
Price Projections
Early Market Launch (2024-2025)
| Price Range |
Rationale |
| $20-$40 per month |
Aligned with current hormone therapy costs, competitive to incentivize adoption |
| Premium pricing ($40+) |
For formulations with proven superior safety/efficacy or convenience |
Long-Term Pricing Outlook (2026+)
| Price Range |
Rationale |
| $15-$25 per month |
As biosimilars or generics enter, competition forces downward pressure |
| Up to $50 per month for novel formulations |
If efficacy/safety advantages are demonstrated and market exclusivity persists |
Based on comparables in the non-hormonal space, initial launch prices for Fezolinetant are likely to be in the $25-$40 per month range, with pressure for price reductions over time.
Market Entry Factors and Risks
- Regulatory approval is a primary determinant of market entry timing.
- Pricing strategy influences market penetration and payer considerations.
- Competitive offerings may limit peak market share.
- Patient acceptance hinges on perceived safety, efficacy, and side-effect profile.
Key Takeaways
- Fezolinetant addresses a growing unmet medical need with a sizeable market potential.
- The drug’s regulatory approval is expected in the next 1-2 years, influencing launch timing.
- Price points will initially compete with hormone therapies, with room for premium positioning if efficacy and safety are superior.
- Market size estimations put initial annual sales potential in the hundreds of millions for North America alone.
- Competitive dynamics and payer policies will strongly influence long-term pricing and market share.
FAQs
1. When is Fezolinetant likely to launch?
FDA approval is expected in 2023-2024, with market entry soon after approval.
2. What factors influence the drug’s pricing?
Regulatory status, competitive landscape, perceived efficacy, safety profile, and payer reimbursement policies.
3. How does Fezolinetant compare to existing therapies?
It offers a non-hormonal alternative targeting vasomotor symptoms, potentially with fewer safety concerns associated with hormone therapy.
4. What is the size of the target market?
Approximately 25 million women in the U.S. with moderate to severe hot flashes, generating a multibillion-dollar market.
5. What are the risks to market penetration?
Regulatory delays, safety concerns, or insufficient efficacy data could impede adoption; market competition and payer restrictions also pose risks.
References
- IQVIA. (2022). US Menopause Market Insights.
- FDA. (2023). Fezolinetant Clinical Trial Data and Regulatory Status.
- Market Data Forecast. (2023). Menopause Market Size and Growth Projections.
- CDC. (2022). Menopause and Vasomotor Symptoms Statistics.
- EvaluatePharma. (2023). Oncology and Hormonal Therapy Market Analysis.
