Last updated: March 13, 2026
What is NDC 42192-0139?
NDC 42192-0139 refers to Eptinezumab (Vyepti), a monoclonal antibody approved by the FDA in February 2020. It is used for the prophylaxis of episodic and chronic migraines in adult patients. Developed by Lundbeck and its partner AstraZeneca, the drug is administered via intravenous infusion typically once every three months.
Current Market Status
Market Size
The migraine medication market is valued at approximately $4.2 billion in 2022, with projections reaching $6 billion by 2027. Eptinezumab’s market penetration remains moderate.
Competition
Other calcitonin gene-related peptide (CGRP) inhibitors include:
- Erenumab (Aimovig)
- Fremanezumab (Ajovy)
- Galcanezumab (Emgality)
All drugs target migraine prevention but differ in administration routes and dosing frequency.
| Product |
Route |
Dosing |
Price per dose (USD) |
Launch Year |
| Eptinezumab (Vyepti) |
IV infusion |
Quarterly |
£3120 |
2020 |
| Erenumab (Aimovig) |
SC injection |
Monthly |
$575 |
2018 |
| Fremanezumab (Ajovy) |
SC injection |
Monthly or quarterly |
$575 |
2018 |
| Galcanezumab (Emgality) |
SC injection |
Monthly or quarterly |
$645 |
2018 |
Market Penetration
- In 2022, vyepti accounted for an estimated 10% of the CGRP inhibitor market.
- The primary use remains in patients with inadequate response or intolerance to oral migraine prophylactics.
Price Projections (2023–2028)
Factors Influencing Pricing
- Reimbursement Dynamics: Insurers’ formulary decisions significantly influence net price.
- Market Competition: Slight price reductions expected with increased competition.
- Manufacturing Costs: Monoclonal antibodies have stable production costs but face patent expirations.
Price Trend Summary
| Year |
Estimated Price per Dose (USD) |
Notes |
| 2023 |
3,120 |
List price, stable since launch |
| 2024 |
3,090 |
Slight reduction due to market pressure |
| 2025 |
3,050 |
Push for value-based reimbursement |
| 2026 |
3,020 |
Increased competition impact |
| 2027 |
2,980 |
Price stabilization, market maturity |
Revenue Projections
Assuming steady uptake, average annual sales could reach:
- 2023: $750 million
- 2024: $810 million
- 2025: $870 million
- 2026: $920 million
- 2027: $960 million
Market Share Growth
Market dominance expected to remain limited due to entrenched competition, with potential growth if new indications or formulations are approved.
Regulatory and Pricing Policies Impact
- Pricing pressures from health authorities and insurers may enforce discounts on list prices.
- Potential for biosimilars post-2027 could drive prices down further.
- Value-based pricing models may lead to price adjustments aligned with clinical outcomes.
Impact of Patent Expiration
The patent expiration for vyepti is anticipated around 2035, suggesting minimal impact on pricing until then. However, biosimilar entries could influence market share and price levels, especially in international markets where patent enforcement is less strict.
Key Takeaways
- NDC 42192-0139 (Vyepti) holds an approximate 10% share of the migraine CGRP inhibitor market.
- List prices remain around $3,120 per infusion with gradual price declines projected through 2027.
- Market penetration hinges on reimbursement policies, comparative efficacy, and safety profiles.
- Competition from oral and injectable therapies limits price escalation.
- Revenue growth is expected to be steady, with potential deceleration after patent expiry and biosimilar entry.
FAQs
1. How does Vyepti compare cost-wise to other CGRP therapies?
Vyepti's list price per infusion is higher than subcutaneous options but is administered quarterly, which may reduce overall treatment cost compared to monthly injectables.
2. What factors could lower future prices?
Market competition, biosimilar development, and reimbursement negotiations can lead to discounts.
3. Is Vyepti heading for patent expiration soon?
Patent protections are expected to last until about 2035, barring legal challenges or patent disputes.
4. How significant is the role of insurance coverage in pricing?
Insurance coverage heavily influences the net price; broader coverage reduces out-of-pocket costs and affects market penetration.
5. What are potential new indications that could impact pricing?
Approval for additional indications, such as cluster headaches, could increase demand and justify maintaining or raising prices.
References
[1] IQVIA. (2022). Global Migraine Market Data.
[2] U.S. Food and Drug Administration. (2020). Approval Letter for Vyepti.
[3] Bloomberg Intelligence. (2023). Biologic and biosimilar market overview.
[4] Drugs.com. (2023). Eptinezumab (Vyepti) Pricing and Administration.
[5] EvaluatePharma. (2022). 2022 Pharmaceutical Revenue Forecasts.
