Last updated: February 14, 2026
What is NDC 16714-0671?
NDC 16714-0671 is a monoclonal antibody product marketed as Eptinezumab (Vyepti), approved by the FDA in February 2020 for preventive treatment of migraine in adults. It is administered intravenously every three months.
Market Size and Competition
Market Overview
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Migraine prevalence: Approximately 12% of the U.S. population, equating to roughly 38 million individuals, suffer from migraine [1].
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Target patients: Estimated 10-20% of migraine sufferers seek preventive therapy, totaling approximately 3.8 - 7.6 million potential patients in the U.S.
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Market penetration: As a recent entrant, Eptinezumab held an estimated 4% share in 2021, with projections suggesting growth to 12% over the next 5 years.
Key Competitors
- Erenumab (Aimovig), approved in 2018
- Fremanezumab (Ajovy), approved in 2018
- Galcanezumab (Emgality), approved in 2018
Market Dynamics
- These competitors have established branded presence and broader office-based administration vs. Eptinezumab’s infusion model.
- The infusion route may limit adoption to specialized settings, affecting market penetration.
Current Pricing and Revenue
Pricing
- Wholesale Acquisition Cost (WAC): Approximately $6,500 per infusion [2].
- The average patient receives 4 infusions annually, leading to $26,000 per year per patient.
Estimated Market Revenue
- If 12% of target population uses the drug, with 4 infusions annually, projected annual revenue in the U.S. could approximate $1.2 billion at full penetration.
- Actual revenue depends on market share, insurance reimbursement, and patient access constraints.
Pricing Trends
- Similar monoclonal antibody therapies for migraine are priced between $5,000–$8,000 per infusion.
- Market entry strategies may lead to discounts or patient assistance programs, potentially reducing net price.
Price Projections (Next 5 Years)
| Year |
Estimated Price per Infusion |
Notes |
| 2023 |
$6,500 |
Current WAC price |
| 2024 |
$6,100–$6,500 |
Slight discounts due to payer negotiations |
| 2025 |
$6,000–$6,300 |
Price stabilization, increased competition |
| 2026 |
$5,800–$6,200 |
Market access efforts, formularies adjustment |
| 2027 |
$5,700–$6,000 |
Standardized insurer reimbursement policies |
Note: These projections assume no major price cuts or scaling efficiencies post-market.
Regulatory and Payer Impact on Pricing
- Reimbursement policies: Payers increasingly favor value-based contracts, pressuring list prices.
- Clinical adoption: Patient acceptance of infusion therapy may influence market size and reimbursement levels.
- Manufacturing costs: As a biologic, manufacturing complexity sustains high prices; however, biosimilar entry is unlikely within the next 10 years.
Key Takeaways
- The current U.S. market price for NDC 16714-0671 (Eptinezumab) averages $6,500 per infusion, with annual treatment costs around $26,000.
- Market penetration is expected to grow, with potential revenues reaching over $1 billion annually in developed markets.
- Price projections indicate marginal declines over the next five years, driven by payer negotiations, competitive pressures, and evolving reimbursement landscapes.
- Entry of biosimilars or alternative therapies could further influence pricing and market share.
FAQs
1. How does Eptinezumab compare to competing migraine preventives regarding price?
It generally exceeds the pricing of oral preventives but aligns with other monoclonal antibody therapies that cost around $6,000–$8,000 per infusion annually.
2. What factors could drive significant price reductions?
Biosimilar development, increased market competition, payer pressure, and clinical guidelines favoring oral options could reduce prices.
3. How does infusion frequency influence total cost?
Eptinezumab's quarterly infusions lead to higher annual costs compared to monthly or weekly oral or injectable therapies.
4. What is the impact of insurance coverage on drug affordability?
Commercial insurers may negotiate discounts or establish proprietary formulary tiers, affecting patient out-of-pocket costs and access.
5. Are there indications for expanding the use of NDC 16714-0671?
While current approved for migraine prevention in adults, ongoing research may explore other indications, potentially expanding the market.
References
[1] American Migraine Foundation. "Migraine facts."
[2] GoodRx. "Eptinezumab (Vyepti) prices and discounts."
