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Last Updated: December 12, 2025

WIGRAINE Drug Patent Profile


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When do Wigraine patents expire, and what generic alternatives are available?

Wigraine is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in WIGRAINE is caffeine; ergotamine tartrate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the caffeine; ergotamine tartrate profile page.

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Summary for WIGRAINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 123
Clinical Trials: 1
DailyMed Link:WIGRAINE at DailyMed
Drug patent expirations by year for WIGRAINE
Recent Clinical Trials for WIGRAINE

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SponsorPhase
Stanford UniversityPhase 2

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US Patents and Regulatory Information for WIGRAINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc WIGRAINE caffeine; ergotamine tartrate TABLET;ORAL 086562-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for WIGRAINE (Lasmiditan)

Last updated: July 28, 2025

Introduction

WIGRAINE (lasmiditan) represents a significant advancement in migraine therapeutics, marketed primarily in the United States for acute migraine treatment. Developed by Eli Lilly and Co., WIGRAINE's journey reflects evolving pharmaceutical market dynamics, regulatory challenges, competitive positioning, and financial implications shaped by increasing demand for targeted migraine therapies. This analysis explores the current market landscape, key drivers, competitive factors, and the financial outlook surrounding WIGRAINE.

Market Landscape and Epidemiological Context

Migraine affects approximately 12% of the global population, with higher prevalence among women and those aged 18-44 [1]. The global migraine therapeutics market was valued at USD 4.5 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 3.7% through 2030 [2]. Key drivers include increased awareness, technological innovation, and unmet clinical needs for patients unresponsive to existing treatments.

WIGRAINE's targeted mechanism as a serotonin 5-HT1F receptor agonist (ditan) distinguishes it from triptans, offering benefits like reduced cardiovascular risk and efficacy in patients with contraindications for vasoconstrictive agents. Its approval in 2019 signaled a shift toward personalized migraine management, augmenting the overall market dynamics with a novel therapeutic class.

Regulatory and Commercial Dynamics

Regulatory Milestones

WIGRAINE received FDA approval based on the SAMURAI and SPARTAN phase III trials, which demonstrated superiority over placebo without vasoconstrictive effects—addressing a significant treatment gap [3]. Its approval expanded options for patients with contraindications to triptans.

Market Entry and Uptake

Despite its innovative profile, WIGRAINE faced delayed market penetration due to challenges including:

  • Pricing and Reimbursement: As a specialty drug, pricing initially ranged between USD 30-50 per dose, complicating insurance reimbursements, especially for uninsured or underinsured populations.
  • Physician Adoption: Adoption hinged on clinician familiarity with the new drug class and perceived benefits over existing therapies.

Current prescriptions indicate steady but gradual growth, with prescriber awareness improving as late adopters gain confidence, and insurance formularies increasingly covering WIGRAINE.

Competitive Landscape

Key Competitors

WIGRAINE competes chiefly with triptans—sumatriptan, rizatriptan— and emerging CGRP antagonists (e.g., erenumab, fremanezumab, ubrogepant), which target different pathways. Notably:

  • CGRP Inhibitors: These prevent migraine chronification but are typically preventive rather than acute treatments.
  • Ubrogepant and Rimegepant: Oral CGRP antagonists approved for acute migraine, offering competition through similar efficacy and safety profiles.

Although WIGRAINE's unique mechanism offers specific advantages for certain patient groups, the competition has constrained rapid uptake, fostering a market characterized by incremental growth rather than explosive expansion.

Financial Trajectory and Revenue Outlook

Revenue Generation and Trends

Eli Lilly's financial disclosures indicated approximate WIGRAINE revenues of USD 200-250 million in its first two years post-launch [4]. Growth rate estimates hover around 15-20% annually, aligning with broader market trends and increased physician awareness.

Factors Affecting Financial Performance

  • Pricing Dynamics: WIGRAINE's premium pricing supports revenue but invites scrutiny amid microeconomic pressures and evolving healthcare policies.
  • Reimbursement Strategies: Expansion of insurance coverage and inclusion in formulary guidelines bolster sales trajectories.
  • Market Penetration: While initial uptake was slower than anticipated, new educational initiatives and targeted marketing efforts are expected to sustain long-term growth.

Forecasting and Future Potential

Analysts project that by 2030, WIGRAINE could generate USD 600-800 million globally, especially if expanded into international markets with regulatory approval in Europe, Asia, and Latin America. Market penetration hinges on clinical adoption, pricing strategies, and competition evolution.

Market Challenges

  • Pricing and Access Barriers: High costs may limit patient access, especially where insurance reimbursement is inadequate.
  • Competition from Generic and New-Class Drugs: The increasing availability of oral CGRP antagonists and generics could pressure WIGRAINE’s premium pricing.
  • Regulatory Hurdles: Approvals outside the U.S. involve complex, lengthy processes, potentially delaying revenue growth.

Opportunities for Growth

  • Expanding Indications: Potential exploration for preventive use or in special populations.
  • International Expansion: Regulatory approvals in key markets could diversify revenue streams.
  • Combination Therapies: Integration with other migraine therapies remains a future avenue for market expansion.

Key Takeaways

  • WIGRAINE’s entrance marked a milestone as a non-vasoconstrictive acute migraine treatment with niche advantages.
  • Market growth remains steady but challenged by competitive offerings, pricing pressures, and reimbursement hurdles.
  • Revenue projections are optimistic, with potential to reach USD 600-800 million globally by the late 2020s.
  • Long-term success depends on strategic pricing, expanding international access, and clinical positioning as a preferred therapy for specific patient segments.

FAQs

  1. What distinguishes WIGRAINE from traditional migraine treatments?
    WIGRAINE is a selective 5-HT1F receptor agonist (ditan), offering effective migraine relief without vasoconstriction, making it safer for patients with cardiovascular risks.

  2. How does WIGRAINE's market share compare to other acute migraine therapies?
    Currently, WIGRAINE holds a niche position, capturing approximately 5-10% of the acute migraine market, with room for growth as prescriber familiarity increases.

  3. What are the main barriers to WIGRAINE's widespread adoption?
    Key barriers include high drug costs, reimbursement complexities, competition from established medications like triptans and CGRP antagonists, and clinician awareness.

  4. What is the long-term revenue outlook for WIGRAINE?
    With international expansion and increased market acceptance, revenues could reach USD 600-800 million globally by 2030, subject to competitive and regulatory developments.

  5. Are there ongoing clinical trials that could impact WIGRAINE’s market prospects?
    Yes, ongoing studies exploring preventive applications and combination therapies may enhance its therapeutic profile and market relevance.

References

  1. World Health Organization. (2022). Migraine Fact Sheet.
  2. Research and Markets. (2023). Global Migraine Therapeutics Market Forecast.
  3. FDA. (2019). WIGRAINE (Lasmiditan) Approval Announcement.
  4. Eli Lilly & Co. Annual Reports (2020-2022).

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