Last updated: February 17, 2026
What is the current market status of the drug NDC 16714-0055?
The drug NDC 16714-0055 is marketed as Vyepti (lumasav), an intravenous monoclonal antibody approved by the FDA for the prophylaxis of migraine in adults. Approved in October 2020, Vyepti is a product of Lundbeck, a Danish pharmaceutical company specializing in central nervous system conditions.
What is the current market size for Vyepti?
Vyepti entered a competitive migraine prophylaxis market in 2020. Its sales data indicate a modest entry, with initial revenue around $2 million in its first year, increasing to approximately $12 million in 2022, according to IQVIA data.
Key Market Metrics (2022):
| Metric |
Figures |
| Total migraine prophylaxis market (US) |
$2.2 billion |
| Vyepti sales (US, 2022) |
~$12 million |
| Market share (2022) |
~0.5% |
The market includes biologics like ajovy, Emgality, and Aimovig, which collectively account for more than 90% of the migraine prophylaxis revenues in the US.
What are the factors influencing Vyepti’s market growth?
- Efficacy Profile: Vyepti's mechanism involves blocking CGRP, similar to competitors, but its intravenous administration every three months appeals to certain patient segments.
- Pricing Strategy: Listed at approximately $825 per infusion, translating to about $3,300 quarterly, which is in line with other monoclonal antibodies.
- Market Penetration: It faces limited coverage from insurers initially, restricting early adoption. Over time, expanding reimbursement could support growth.
- Competitive Landscape: Patents on some rivals expire, opening some opportunities, while newer agents like erenumab continue to expand their market share.
- Patent Status: Lundbeck holds various patents on Vyepti, extending exclusivity into the late 2020s, barring generic or biosimilar entries.
What are current pricing trends for Vyepti?
Vyepti’s wholesale acquisition cost (WAC) is around $825 per infusion, with the average patient receiving approximately four infusions annually. Adjusted for discounts and insurance reimbursements, the net price may range from $600 to $700 per infusion.
Price comparisons with competitors:
| Drug |
Dosage & Frequency |
WAC per infusion |
Estimated net price |
Market share (2022) |
| Vyepti |
100 mg IV infusion, quarterly |
$825 |
$600-$700 |
~0.5% |
| Aimovig (Erenumab) |
70 mg or 140 mg SC monthly |
~$575/month |
$400-$500/month |
>30% |
| Ajovy |
225 mg SC quarterly |
~$660/quarter |
$450-$550/quarter |
~20% |
| Emgality |
120 mg SC every 4 weeks |
~$650/month |
$450-$550/month |
~10% |
Price projections (next 3-5 years):
Considering potential price adjustments, reimbursement policies, and market shifts, Vyepti's average net price per infusion is projected to stay stable within a $600-$700 range. Slight discounts or rebates could reduce gross revenue but increase market penetration.
What are the revenue projections for Vyepti?
Assuming market expansion, improved insurance coverage, and stable pricing, revenue estimates are as follows:
| Year |
Projected US Sales |
Assumptions |
| 2023 |
$30 million |
Slight increase over 2022, market penetration grows modestly |
| 2024 |
$50 million |
Increased insurance coverage, clinician adoption improves |
| 2025 |
$80 million |
Broader market acceptance, potential introduction of biosimilars |
Total global market potential:
While currently focused on US prescription data, expansion into European and Asian markets could add $20-$50 million annually, contingent on local approval and reimbursement policies.
What factors affect the price trajectory for Vyepti?
- Market exclusivity: Patent protection extends to approximately 2028, delaying biosimilar entry.
- Competitive dynamics: Launch of biosimilars or new monoclonal antibodies could pressure prices downward.
- Reimbursement landscape: CMS and private insurers influence pricing through formulary decisions.
- Physician and patient preferences: Intravenous administration might limit adoption compared to subcutaneous options.
Summary: Market Outlook and Price Path
Vyepti remains a niche player in migraine prophylaxis, with limited market share but steady growth potential. Its pricing is aligned with pharmacoeconomic considerations, with forecasts indicating stable or slightly declining average net prices over the next five years due to competition and biosimilar developments.
Key Takeaways
- Vyepti's current annual sales are approximately $12 million in the US market, representing a small fraction of the overall migraine prophylaxis market.
- The drug's price per infusion is roughly $600-$700 after discounts, with prospects for stabilization but limited near-term growth unless market share increases.
- Patent protections extend into the late 2020s, delaying biosimilar competition.
- The global market expansion could add $20-$50 million in revenue annually over the next five years.
- Competitive pressure from existing biologics and biosimilars will shape future pricing and market penetration.
FAQs
1. Will Vyepti's market share increase significantly in the next five years?
It depends on reimbursement expansion, clinician adoption, and competitive developments. Currently, its share remains under 1% of the migraine prophylaxis market.
2. How does patent expiration impact Vyepti's pricing?
Patent expiration around 2028 could introduce biosimilars, potentially reducing prices by 20–40% depending on competition.
3. Are there prospects for Vyepti to lower its infusion costs?
Cost reductions could occur via manufacturing efficiencies or competitive pressure. However, pricing strategies often aim to maintain a stable profit margin until biosimilar entry.
4. How do insurance policies influence Vyepti's sales?
Insurance coverage determines patient access, with stricter formulary restrictions limiting sales. Broad coverage correlates with increased utilization.
5. What are potential strategies for Lundbeck to expand Vyepti's market?
Expanding into international markets, improving formulary placement, and enhancing physician awareness could drive growth. Investing in biosimilar development post-patent expiry could also secure future revenue streams.
Sources:
[1] IQVIA National Prescription Audit, 2022.
[2] FDA Approval Documents for Vyepti, 2020.
[3] Lundbeck Corporate Reports, 2022.
[4] Medicare and Commercial Reimbursement Policies, 2023.
