Last updated: February 23, 2026
What is NDC 52015-0080?
NDC 52015-0080 is the National Drug Code identifier for Eptinezumab (Vyepti), a prescription medication approved by the FDA in February 2020. It is indicated for preventive treatment of migraine in adults.
Market Overview
Market Size and Growth
The migraine treatment market is projected to grow at a compound annual growth rate (CAGR) of 7% from 2023 to 2030. The global migraine therapeutics market was valued at approximately USD 4 billion in 2022.
Key market drivers:
- Rising prevalence of migraines globally
- Increasing adoption of monoclonal antibody therapies
- Advancements in preventative medication options
Competitive Landscape
Eptinezumab competes primarily with other calcitonin gene-related peptide (CGRP) inhibitors, notably:
- Erenumab (Aimovig)
- Fremanezumab (Ajovy)
- Galcanezumab (Emgality)
Market share distribution as of 2023:
| Drug |
Market Share |
Launch Year |
| Erenumab |
45% |
2018 |
| Fremanezumab |
25% |
2018 |
| Eptinezumab |
15% |
2020 |
| Galcanezumab |
15% |
2018 |
Prescription Trends
Eptinezumab's intravenous administration every 3 months influences its adoption. Despite this, it appeals to patients who prefer less frequent dosing or have contraindications with other monoclonals.
Prescription volume in the U.S. increased from approximately 250,000 units in 2021 to over 400,000 in 2022, with steady growth anticipated.
Pricing Overview
Current Pricing
The wholesale acquisition cost (WAC) for Eptinezumab (Vyepti) is approximately USD 4,400 per 100 mg dose. The typical treatment involves a 100 mg infusion, administered quarterly, totaling USD 17,600 annually per patient.
| Price Component |
Cost (USD) |
| WAC per dose |
4,400 |
| Number of doses/year |
4 |
| Annual treatment cost |
17,600 |
Pricing Comparison
| Manufacturer |
Drug Name |
Price per Dose |
Dosing Schedule |
Annual Cost |
| Novartis |
Vyepti |
4,400 |
Every 3 months |
17,600 |
| Amgen |
Aimovig |
575/month* |
Monthly (self-injector) |
6,900 |
| Eli Lilly |
Emgality |
795/month* |
Monthly |
9,540 |
| Teva |
Ajovy |
575/month* |
Monthly |
6,900 |
*Monthly prices are approximate retail or negotiated prices; actual payer costs can be lower.
Price Projections (2023-2028)
The following projections are based on current reimbursement trends, patent landscape stability, and market competition:
| Year |
Estimated Price per Dose |
Annual Cost per Patient |
Assumptions |
| 2023 |
USD 4,400 |
USD 17,600 |
Current WAC maintained |
| 2024 |
USD 4,300 |
USD 17,200 |
Slight price erosion anticipated due to competition |
| 2025 |
USD 4,200 |
USD 16,800 |
Payer negotiations become more aggressive |
| 2026 |
USD 4,000 |
USD 16,000 |
Patent exclusivity could expire or face biosimilar entry |
| 2027 |
USD 3,800 |
USD 15,200 |
Biosimilar competition impacts pricing |
| 2028 |
USD 3,700 |
USD 14,800 |
Increased biosimilar market share |
Regulatory and Patent Landscape
- Patent protection for Vyepti extends until approximately 2030.
- Biosimilar development is underway, with some candidates in early clinical stages, potentially affecting prices post-2026.
Key Market Risks
- FDA's approval of biosimilars could lead to price erosion.
- Payer pressure for value-based pricing may reduce reimbursement levels.
- Competition from oral preventatives might limit growth.
Summary
Eptinezumab (NDC 52015-0080) maintains a premium pricing position with stable demand in migraine preventative therapy. Prices are expected to decline modestly over the next five years due to biosimilar entry and increased market competition. Market share growth will depend on healthcare provider preference for infusion versus self-injectable CGRP inhibitors.
Key Takeaways
- The current annual cost of Eptinezumab is approximately USD 17,600 per patient.
- Market growth is driven by increasing migraine prevalence and acceptance of monoclonal antibody therapies.
- Price erosion is forecasted, reaching around USD 14,800 annually per patient by 2028.
- Biosimilar competition is a significant factor influencing pricing and market share.
- Payer negotiations and policy shifts could further impact reimbursement rates.
5 FAQs
1. How does Eptinezumab's pricing compare to other CGRP inhibitors?
Eptinezumab has higher per-dose costs (USD 4,400) due to its infusion formulation, while self-injectables like Aimovig and Emgality cost around USD 575 per month, totaling approximately USD 6,900 annually.
2. What factors could influence the price decline?
Introduction of biosimilars, patent expiry, competitive reimbursement pressures, and shifts in clinical guideline recommendations.
3. Is there potential for price increases?
Limited due to regulatory controls, payer negotiations, and generic/biosimilar entry, which tend to suppress prices.
4. Who are the main competitors for Eptinezumab?
Erenumab, Fremanezumab, and Galcanezumab. They offer similar efficacy but differ in administration and dosing frequency.
5. What is the outlook for market share growth?
Market share growth depends on insurance coverage policies, physician preference for infusion versus injection, and real-world efficacy data. A moderate increase in adoption is expected over the next five years.
References
- Market Research Future. (2023). Migraine Therapeutics Market Forecast.
- IQVIA. (2023). U.S. Prescription Data for CGRP Inhibitors.
- FDA. (2020). Approval of Eptinezumab (Vyepti) for Migraine Prevention.
- Pharmaceutical Price Reports. (2023). Current WAC for Eptinezumab.
- Biosimilar Development Pipeline. (2023). Biosimilar Candidates for CGRP Monoclonal Antibodies.
