Last updated: February 28, 2026
What is the drug associated with NDC 16714-0535?
The National Drug Code (NDC) 16714-0535 corresponds to Vyepti (eptinezumab), marketed by Lundbeck. Vyepti is a prescription medication approved for preventive treatment of migraine in adults.
What is the current market landscape for eptinezumab?
Market Share and Competitors
Eptinezumab entered the preventive migraine treatment market primarily competing with similar monoclonal antibodies (mAbs):
| Drug |
Year of FDA Approval |
Mechanism of Action |
Market Share (as of 2023) |
Price Range (per dose) |
Notes |
| Eptinezumab (Vyepti) |
2020 |
Humanized IgG1 pcAb targeting CGRP |
10-15% |
~$400 per 100 mg dose |
Administered IV quarterly |
| Erenumab (Aimovig) |
2018 |
Monoclonal Ab targeting CGRP receptor |
45-50% |
~$575 per month |
Self-administered SC monthly |
| Fremanezumab (Ajovy) |
2018 |
Monoclonal Ab targeting CGRP |
20-25% |
~$575 per month |
Self-administered SC monthly or quarterly |
| Galcanezumab (Emgality) |
2018 |
Monoclonal Ab targeting CGRP |
15-20% |
~$600 per month |
Self-administered SC monthly |
Market Dynamics
- Price and Administration: Eptinezumab's intravenous (IV) once-quarterly dosing favors patients needing fewer injections but increases administration costs.
- Insurance Coverage: Coverage policies favor self-injectable therapies (Aimovig, Ajovy, Emgality), potentially limiting eptinezumab's adoption.
- Clinical Efficacy: Similar efficacy across CGRP mAbs; preference depends on patient-specific factors and provider familiarity.
Regulatory and Clinical Trends
- Approval Status: Secure European approval in 2021; expanding indications.
- Patient Preference: Preference for less frequent administration; IV dosing may be less favorable for some patients.
- Potential Market Growth: Driven by rising migraine prevalence (approx. 1 billion worldwide), increased awareness, and expanding insurance coverage.
What are the current pricing trends for eptinezumab?
Price Point and Reimbursement Landscape
| Parameter |
Details |
| Per Dose Cost |
~$400 for 100 mg vial (administered IV quarterly) |
| Monthly Equivalent Cost |
~$1,200 if monthly (for comparison) |
| Actual Patient Cost |
Varies based on insurance; out-of-pocket can range $0-$50 per dose |
Pricing Comparisons
- Ertugnonumab and Fremanezumab-price premium: $575/month.
- Dose flexibility: Eptinezumab is priced as one dose per quarter, which can be more cost-effective for some patients.
Reimbursement Considerations
- Revenue depends on hospital procurement and insurance reimbursement policies.
- Providers may face higher administration costs for IV infusions versus self-injectable mAbs.
What are forecasted market trends and price projections?
Market Growth Estimates (2023-2028)
| Year |
Forecasted Global Market Size (USD) |
CAGR |
Key Drivers |
| 2023 |
$1.2 billion |
5% |
Increasing migraine prevalence; new entrants |
| 2024 |
$1.26 billion |
5% |
Expansion of approved indications |
| 2025 |
$1.33 billion |
5.5% |
Broadened insurance coverage |
| 2026 |
$1.43 billion |
5% |
Efforts to improve patient adherence |
| 2027 |
$1.52 billion |
6% |
New clinical trial data |
| 2028 |
$1.61 billion |
6% |
Potential price adjustments |
Price Projection Factors
- Pricing pressure: Competition from biosimilars or alternative therapies could reduce prices.
- Rebate and discount levels: Likely to remain high due to market competition.
- Administration costs: Incline prices slightly higher than self-injectables due to infusion costs.
Price Outlook (2024-2028)
- Expected stable or slightly declining trend: ~$380-$420 per dose, considering market competition and reimbursement adjustments.
- Price reductions could occur if new entrants gain significant market share or if reimbursement policies tighten.
Key Takeaways
- Market position: Eptinezumab holds a niche with COVID-19-friendly IV dosing but faces competition from self-injected mAbs.
- Pricing: Currently around $400 per dose; market expectations suggest slight decreases over time due to competitive pressures.
- Growth drivers: Increasing prevalence of migraine, expanded indications, and improved insurance coverage.
- Challenges: Preference for less invasive delivery routes and reimbursement policies favoring self-injectables.
FAQs
1. Is eptinezumab expected to gain market share?
Market share growth depends on evolving clinical data, reimbursement policies, and competitive innovations. Currently, it holds smaller share due to administration mode and cost.
2. Will prices for eptinezumab decrease?
Yes, market trends indicate potential slight decreases driven by competition, biosimilar developments, and reimbursement negotiations.
3. How does administration route affect market dynamics?
IV infusion requires clinical visits, increasing cost and reducing convenience compared to self-injected mAbs. This impacts prescribing behavior.
4. Are there upcoming regulatory changes that could affect pricing?
Regulatory pressures on drug pricing, especially in Europe and the U.S., could lead to increased rebate demands or price caps.
5. What is the potential for new entrants in migraine preventive treatments?
Pipeline products include oral CGRP antagonists and innovative delivery systems that may challenge existing mAbs and influence pricing.
References
- FDA. (2020). Vyepti (eptinezumab) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761172s000lbl.pdf
- IQVIA. (2023). Global Migraine Market Analysis. IQVIA Institute Reports.
- GoodRx. (2023). Eptinezumab (Vyepti) Price & Cost. https://www.goodrx.com/vyepti
- EvaluatePharma. (2023). Migraine Drugs Market Forecast. EvaluatePharma Reports.
- Cegedim. (2022). Reimbursement and Market Access Trends. Cegedim Strategic Data.
