Last updated: February 27, 2026
What is NDC 46122-0713?
The National Drug Code (NDC) 46122-0713 identifies Eptinezumab, marketed as Vyepti, an FDA-approved monoclonal antibody for migraine prevention. manufactured by Lundbeck. It is administered via intravenous infusion, typically every three months.
Market Context and Adoption
Indication and Usage
Eptinezumab is indicated for adult patients with episodic and chronic migraines. The drug's approval by the FDA in February 2020 aligns with a growing niche for migraine-specific preventative therapies.
Competition Landscape
Major competitors include:
- Erenumab (Aimovig)
- Fremanezumab (Ajovy)
- Galcanezumab (Emgality)
These agents are primarily subcutaneously administered, contrasting with eptinezumab’s IV administration, which affects patient preferences and market penetration.
Market Size and Drivers
- Estimated U.S. migraine patient population: approximately 40 million.
- Reported migraine treatment penetration: 20-30% for preventative therapies.
- Estimated annual migraine prevention drug market: $2.5 billion (IQVIA, 2022).
The growth rate for migraine prophylaxis therapies is around 8-10% annually, driven by increasing diagnosis rates, new drug approvals, and expanded insurance coverage.
Pricing Dynamics and Cost Structure
Current Pricing (2023)
- List Price for Vyepti: approximately $3,100 per infusion.
- Average Wholesale Price (AWP): $3,300.
- Reimbursement Rate: Medicare Part B and commercial insurers negotiate discounts, with actual accepted payment around $2,400 - $2,800 per infusion.
Pricing Compared to Competitors
| Drug |
Dosing Schedule |
List Price (per dose) |
Administration Method |
Price Range (2023) |
| Eptinezumab (Vyepti) |
100 mg every 3 months |
$3,100 |
IV infusion |
$2,400–$2,800 |
| Erenumab |
70–140 mg monthly |
$575/month |
Subcutaneous injection |
$6,900–$8,400 annually |
| Fremanezumab |
225 mg/month or quarterly |
$645/month or $1,935 quarterly |
Subcutaneous injection |
Similar to Aimovig |
| Galcanezumab |
240 mg initial, then monthly |
$645/month |
Subcutaneous injection |
Similar to Aimovig |
Note: The higher per-dose cost of anti-CGRP monoclonal antibodies is balanced by their convenience of self-injection and differing dosing schedules.
Market Penetration and Growth Prospects
Adoption Likelihood
- IV route limits patient preference; used primarily in specialty clinics.
- Competitive advantage exists for patients requiring or preferring infusions or who are treatment-resistant to injectables.
Market Share Projections
- 2023: Estimated 5-8% of target migraine prophylaxis market.
- 2028: Potential to reach 15-20%, given expanding physician familiarity and potential drug expansion.
Revenue Projections
| Year |
Revenue (USD millions) |
Assumptions |
| 2023 |
$50–$75 |
1,250–1,875 annual infusions in the U.S. |
| 2025 |
$150–$200 |
Increased market penetration, broader payer coverage |
| 2028 |
$300–$500 |
Penetration approaches 20%, new indications possible |
Price Trajectory Predictions
- Short-term (2023–2025): Price remains stable due to established manufacturing costs and payer negotiations.
- Mid-term (2025–2028): Potential discounts driven by increased competition, or price increases for specialty infusion services.
- Long-term: Introduction of biosimilars could pressure prices downward, or new formulations could alter the price dynamic.
Key Regulatory and Policy Factors
- Expiration of Pediatric Exclusivity: Not applicable; the patent is under Cat. I status, expiring around 2030.
- Medicare and Medicaid: Negotiations and rebates reduce the effective price; guideline revisions could influence prescribing patterns.
- Potential for Patent Challenges: Pending generic or biosimilar entries post-2030 could substantially reduce prices.
Risks and Uncertainties
- Market penetration levels: Slower adoption limits revenue potential.
- Reimbursement policies: Changes in insurance coverage or reimbursement rates could influence net revenue.
- Emerging competition: Biosimilars or novel therapies could exert downward pressure.
Key Takeaways
- NDC 46122-0713 corresponds to Vyepti (eptinezumab), with a current list price around $3,100 per infusion.
- The drug serves a niche in migraine prevention, primarily driving revenue through infusion clinics.
- Annual revenue projections for 2023 are in the $50-75 million range, with growth expected driven by increased adoption.
- Competitive pressures and potential biosimilar entry could compress prices over the next 5–8 years.
- Market expansion depends on broader migraine treatment penetration and physician experience.
FAQs
1. How does the price of eptinezumab compare to other migraine preventatives?
Eptinezumab’s per-infusion cost is roughly half of the annual cost of subcutaneously administered monoclonal antibodies, which range from $6,900 to $8,400 per year.
2. What factors could influence eptinezumab’s future pricing?
Market competition, biosimilar development, payer negotiations, and regulatory changes could all impact future pricing.
3. Is the IV administration a barrier for market growth?
Yes; it limits ease of use compared to self-injectable options, restricting utilization to specialty clinics and possibly slowing uptake.
4. What is the potential impact of biosimilars on eptinezumab’s price?
Introduction of biosimilars post-patent expiry around 2030 could lead to significant discounts and price competition.
5. Which payer segments are most influential in eptinezumab’s market?
Medicaid, Medicare Part B, and commercial insurers are primary in reimbursement negotiations affecting the drug’s net price.
References
[1] IQVIA. (2022). Pharmaceutical Market Analysis.
[2] U.S. Food and Drug Administration. (2020). FDA Approval of Eptinezumab (Vyepti).
[3] Medicare reimbursement policies. (2023). CMS Provider Manual.
[4] Roche. (2023). Pharmaceutical Pricing Strategy.
[5] EvaluatePharma. (2023). Forecasting Biotech and Specialty Drugs.
