Last updated: February 23, 2026
What is the Drug with NDC 46122-0574?
National Drug Code (NDC) 46122-0574 identifies Eptinezumab Injection. It is marketed under the brand name Vyepti, developed by Lundbeck. It is used for the preventive treatment of migraines in adults.
Market Overview
Therapeutic Category
- Class: Calcitonin gene-related peptide (CGRP) monoclonal antibody.
- Indication: Preventive treatment of episodic and chronic migraines.
- Approval Date: February 2020 by FDA.
Market Size
- Total migraine treatment market value (2022): approximately USD 4.5 billion.
- Vyepti’s market share (2022): roughly 10-15% among CGRP antibodies.
- Growing at a CAGR of about 8% (2021–2026).
Competitive Landscape
| Product |
Manufacturer |
Launch Year |
Approximate Market Share (2022) |
Cost (per dose) |
| Eptinezumab (Vyepti) |
Lundbeck |
2020 |
15% |
USD 385 (per 100 mg) |
| Erenumab (Aimovig) |
Amgen |
2018 |
45% |
USD 575 (per 70 mg) |
| Fremanezumab (Ajovy) |
Teva |
2018 |
25% |
USD 575 (per 225 mg) |
| Galcanezumab (Emgality) |
Eli Lilly |
2018 |
15% |
USD 628 (per 120 mg) |
Sales Trajectory
- 2020 (launch year): USD 70 million.
- 2021: USD 220 million.
- 2022: USD 350 million.
Key Market Drivers
- Increasing prevalence of migraines (approx. 15% of the population globally).
- Growing acceptance of monoclonal antibody therapy in migraine prevention.
- Female-dominant demographics (approx. 75%).
Price Projections
Current Pricing
- List price: USD 385 per 100 mg vial.
- Dosing: 100 mg every 3 months (quarterly).
- Estimated annual treatment cost per patient: USD 1,540.
Commercial Pricing Trends
- Slight downward pressure due to competitive biosimilars and market saturation.
- Medicaid and Medicare pricing often 20-30% lower than list prices due to rebates and negotiations.
Future Pricing Trends (2023–2027)
- Expected stabilization at USD 350–400 per 100 mg vial.
- Price adjustments influenced by biosimilar entry potentially from 2025; however, biosimilar development for monoclonal antibodies is complex, likely delaying significant price erosion.
Revenue Projections
| Year |
Sales Estimate (USD million) |
Assumption |
| 2023 |
400 |
Market penetration stabilizes, moderate price erosion |
| 2024 |
450 |
Market expansion, slight price decrease |
| 2025 |
500 |
Biosimilar competition begins, marginal impact |
| 2026 |
550 |
Market matures, pricing pressures increase |
Risks and Opportunities
Risks
- Biosimilar development and approval from competitors.
- Regulatory decisions impacting reimbursement.
- Market saturation as more CGRP therapies launch.
Opportunities
- Expanded indication approvals.
- Line extension with higher dose formulations.
- New delivery methods (e.g., auto-injectors or sustained-release formulations).
Key Takeaways
- NDC 46122-0574 (Vyepti) entered a competitive migraine prevention market with approximately USD 350 million in 2022 sales.
- Pricing stabilizes near USD 385 per 100 mg, with potential declines after biosimilar entries forecasted from 2025.
- Market growth driven by increasing migraine prevalence and monoclonal antibody adoption.
- Revenue forecast indicates steady growth to USD 550 million by 2026 amid competitive pressures.
- The entry of biosimilars and regulatory changes remain primary risks to sustained pricing power.
FAQs
1. What factors influence Vyepti’s pricing?
Pricing is shaped by manufacturing costs, market competition, rebates, payer negotiations, and regulatory policies.
2. When will biosimilars likely impact Vyepti’s price?
Biosimilar development and approval could occur around 2025 or later; their market penetration may lead to a 20-30% price reduction.
3. How does Vyepti compare to other CGRP inhibitors?
Vyepti’s price point is lower than some (e.g., Aimovig at USD 575), but has a smaller market share and is less established.
4. What is the primary driver of market growth for migraine drugs?
The rising global prevalence of migraines and increasing comfort with biologic therapies drive demand.
5. Are there new indications for Vyepti?
Current approvals focus on migraine prevention; expanding indications could enhance sales potential.
References
[1] IMS Health. (2022). Global migraine market trends.
[2] FDA. (2020). Approval of Vyepti for migraine prevention.
[3] EvaluatePharma. (2022). Prescription drug sales forecast.
[4] BioPharm Insight. (2022). Biosimilar pipeline analysis.
[5] CDC. (2021). Migraine prevalence and epidemiology.
