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Last Updated: May 16, 2025

VYEPTI Drug Profile


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Summary for Tradename: VYEPTI
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for VYEPTI
Recent Clinical Trials for VYEPTI

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Chicago Headache Center & Research InstitutePhase 4
H. Lundbeck A/SPhase 4
H. Lundbeck A/SPhase 3

See all VYEPTI clinical trials

Pharmacology for VYEPTI
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for VYEPTI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for VYEPTI Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for VYEPTI Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: VYEPTI

Introduction

VYEPTI, a calcitonin-gene-related peptide (CGRP) medication developed by Lundbeck, has been making significant strides in the market since its approval in 2020. This biologic drug, administered via IV infusion, targets and blocks the binding site of CGRP, a protein associated with migraine pain. Here, we delve into the market dynamics and financial trajectory of VYEPTI.

FDA Approval and Market Entry

VYEPTI received FDA approval in February 2020 for the preventative treatment of migraines in adults. This approval marked a significant milestone, as it introduced a new treatment option in the CGRP migraine therapy market, which also includes other treatments like Aimovig, Ajovy, and Emgality, administered as injections, and NURTEC ODT, an oral pill[1][3][4].

Market Performance

Since its approval, VYEPTI has demonstrated robust market performance. From 2020 to the first half of 2022, VYEPTI's sales jumped by 120%, reaching over 390 million Danish Krone (DKK). In the second quarter of 2022, sales were reported at 220 million DKK[1].

Recent Financial Highlights

In the first quarter of 2024, VYEPTI continued its strong growth trajectory, with revenue reaching DKK 617 million, an increase of 79% in constant exchange rates (CER) and 76% in DKK. This significant growth underscores the drug's increasing market acceptance and penetration[2].

Global Expansion

VYEPTI's global rollout has been on track, with launches in ten markets in 2023. The drug has secured coverage for 80% of Canadians across healthcare plans and was approved as the first reimbursed migraine IV treatment in Australia. In the U.S., VYEPTI's revenue grew by 447% CER from the third quarter of 2022 to the third quarter of 2023[3].

Competitive Landscape

The CGRP migraine treatment market is competitive, but VYEPTI's unique administration method via IV infusion sets it apart. While other treatments are administered as injections or oral pills, VYEPTI's IV infusion has found a niche, particularly in patients who may prefer or require this method of administration[1].

Clinical Efficacy

Clinical trials have shown that VYEPTI is effective in reducing migraine days. Patients treated with VYEPTI experienced fewer days of migraine headaches compared to those receiving a placebo. The drug has demonstrated significant reductions in migraine frequency and severity, with a notable percentage of patients achieving a 50% or greater reduction in migraine days[4].

Financial Guidance and Performance

Lundbeck has raised its financial guidance following strong growth from its strategic brands, including VYEPTI. In the first half of 2024, revenue from VYEPTI contributed significantly to Lundbeck's overall revenue growth of 10% CER and 8% in DKK. Adjusted EBITDA increased to DKK 3,365 million, reflecting the strong revenue performance across all strategic brands[5].

Revenue Growth

VYEPTI's revenue growth has been a key driver of Lundbeck's financial performance. For the nine months ending in 2023, VYEPTI's global revenue increased by 81% CER, with significant growth in the U.S. and other international markets. This robust revenue performance is attributed to new patient starts and continued strong market dynamics favoring adjunctive therapy in the U.S.[3].

Adjusted EBITDA and EPS

The adjusted EBITDA margin for Lundbeck, influenced by VYEPTI's performance, reached 31.3% in the first half of 2024, despite a slight decrease due to higher raw material and manufacturing costs. Adjusted earnings per share (EPS) increased by 20% to DKK 1.79, reflecting the overall strong financial health of the company[5].

Challenges and Setbacks

Despite the strong financial and market performance, VYEPTI has faced some challenges. Inventory obsolescence and quarterly fluctuations in stock valuation have impacted the drug's financial metrics. However, these setbacks have been managed effectively, and the drug continues to show resilient growth[2][3].

Future Outlook

Lundbeck's continued investment in VYEPTI, including targeted investments in sales and promotion, particularly in the U.S., is expected to drive further growth. The global rollout and securing of reimbursement in various markets are positive indicators for the drug's future performance. As the market for CGRP migraine treatments continues to evolve, VYEPTI is well-positioned to maintain its competitive edge[3][5].

Key Takeaways

  • Strong Revenue Growth: VYEPTI's sales have shown significant growth, with a 120% increase from 2020 to the first half of 2022 and a 79% CER increase in the first quarter of 2024.
  • Global Expansion: The drug has been launched in multiple markets and has secured reimbursement in key regions.
  • Clinical Efficacy: VYEPTI has demonstrated effectiveness in reducing migraine days and severity.
  • Financial Performance: The drug's revenue has contributed substantially to Lundbeck's overall financial performance, with adjusted EBITDA and EPS showing positive trends.
  • Market Dynamics: VYEPTI's unique administration method and strong market acceptance position it well in the competitive CGRP migraine treatment market.

FAQs

What is VYEPTI and how is it administered?

VYEPTI is a biologic drug that targets and blocks the binding site of calcitonin-gene-related peptide (CGRP), a protein associated with migraine pain. It is administered via IV infusion.

When was VYEPTI approved by the FDA?

VYEPTI was approved by the FDA in February 2020 for the preventative treatment of migraines in adults.

How has VYEPTI performed financially since its approval?

Since its approval, VYEPTI has shown strong financial performance, with a 120% increase in sales from 2020 to the first half of 2022 and a 79% CER increase in revenue in the first quarter of 2024.

What sets VYEPTI apart in the CGRP migraine treatment market?

VYEPTI's unique administration method via IV infusion sets it apart from other CGRP treatments, which are administered as injections or oral pills.

What are the clinical benefits of VYEPTI?

Clinical trials have shown that VYEPTI reduces the frequency and severity of migraine days, with a significant percentage of patients achieving a 50% or greater reduction in migraine days.

How has Lundbeck's financial guidance been affected by VYEPTI's performance?

Lundbeck has raised its financial guidance due to the strong growth from VYEPTI and other strategic brands, reflecting positive revenue and adjusted EBITDA trends.

Sources

  1. Oxford Global: "Migraine Drug Doubles its Sales, Despite Expansion Setback"
  2. Lundbeck: "Q1 2024 Corporate Release"
  3. Lundbeck: "9M 2023 Investor presentation"
  4. FDA: "Drug Trials Snapshots: VYEPTI"
  5. Cision: "Lundbeck raised financial guidance following strong growth (+19% CER) from strategic brands"
Last updated: 2024-12-16

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