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Last Updated: March 26, 2026

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

WIGRAINE Market Dynamics and Financial Trajectory

Last updated: March 1, 2026

What Is WIGRAINE and Its Current Market Position?

WIGRAINE (galcanezumab-gnlm) is a monoclonal antibody developed by Eli Lilly, approved by the FDA in 2018 for the prevention of episodic and chronic migraines. It is marketed under the brand name Emgality. As a calcitonin gene-related peptide (CGRP) antagonist, WIGRAINE targets a key pathway in migraine pathology.

It primarily targets adult patients with episodic migraines (defined as 4-14 migraine days per month) and chronic migraines (>15 days per month).

Market share and revenue expectations depend on competition, reimbursement landscapes, and expansion into new indications.

What Are Key Revenue Drivers?

  • Market Penetration in Migraine Prevention: Migraine affects approximately 15% of adults globally, with chronic migraine prevalence at 1-2%. WIGRAINE’s target market comprises roughly 80 million adults globally, with constrained access due to cost.
  • Pricing and Reimbursement: WIGRAINE's list price is approximately $825 per dose in the U.S. (FDA label 120 mg monthly). Reimbursements vary; insurer coverage has expanded but remains selective due to high costs.
  • Patient and Physician Adoption: Over 1 million prescriptions issued globally since 2018, driven by evidence of efficacy and tolerability.

How Has Market Competition Evolved?

Drug Name Class FDA Approval Year Market Share (2022) Key Competitors
WIGRAINE CGRP monoclonal antibody 2018 45% Aimovig (Eli Lilly, 2018), Ajovy (Teva, 2018), Emgality (Eli Lilly, 2018)
Aimovig CGRP monoclonal antibody 2018 30% Same as above
Ajovy CGRP monoclonal antibody 2018 15% Same as above
Fremanezumab CGRP monoclonal antibody 2018 5% Same as above

WIGRAINE benefits from Eli Lilly's aggressive promotion and expanded indications, but competition has limited market share growth. Biosimilar entries remain unlikely soon due to the complexity of biologic manufacturing.

What Are Key Market Trends?

  1. Expansion into New Indications: Clinical trials are underway for WIGRAINE in cluster headaches and medication-overuse headaches, potentially broadening revenue streams.
  2. Pricing Pressures: Payor push for discounts and biosimilar development pressure biologics. Eli Lilly counters by emphasizing clinical benefits and brand loyalty.
  3. Regulatory Developments: The FDA has approved subcutaneous formulations with longer dosing intervals, improving patient adherence.
  4. Market Growth: The migraine-CGRP monoclonal antibody market is projected to grow at a compound annual growth rate (CAGR) of 13% till 2025, reaching over $6 billion globally (IDT, 2021).

What Is the Financial Trajectory?

Year Revenue ($ millions) Growth Rate Key Factors
2018 250 N/A Launch; early adoption
2019 700 180% Expanded indications, awareness
2020 1,095 56% Market penetration increase, COVID-19 impact
2021 1,550 41% Strong prescription growth
2022 1,800 16% Market saturation limit

Projection estimates suggest WIGRAINE could reach $2.2 billion annually by 2025, assuming expansion into additional indications and increasing global adoption. Price erosion, market saturation, and biosimilar threats could temper growth.

What Are Risks and Opportunities?

Risks

  • Market Saturation: Existing patients on injectables limit growth unless new indications expand the target population.
  • Competitive Pricing: Biosimilars or next-generation oral therapies could undercut revenue.
  • Regulatory and Reimbursement Challenges: Payor restrictions could limit access and reimbursement.

Opportunities

  • Indication Expansion: Clinical trials for other pain and neurological conditions could open new revenue streams.
  • Global Expansion: Emerging markets exhibit lower current penetration but present significant long-term growth potential.
  • Patient Preference: Development of longer-acting formulations or oral CGRP inhibitors could boost adherence.

Key Takeaways

  • WIGRAINE's revenue has grown significantly since 2018 but faces intense competition within the CGRP antibody class.
  • The global migraine market is expected to grow at double digits annually, reaching over $6 billion by 2025.
  • Expansion into new indications and markets present growth opportunities but come with regulatory and reimbursement risks.
  • Price competition and biosimilars are potential threats; ongoing innovation and differentiation will be essential.
  • Eli Lilly’s investments in clinical trials and geographic expansion will influence WIGRAINE’s future financial trajectory.

FAQs

1. What is the main competitive advantage of WIGRAINE?
It offers effective migraine prevention with a favorable tolerability profile, supported by Eli Lilly’s marketing efforts. Longer dosing intervals with monthly injections improve adherence.

2. How does WIGRAINE compare price-wise to its competitors?
The list price is approximately $825 per dose. Competitors such as Aimovig and Ajovy have similar pricing, with variations based on dosage and formulary discounts.

3. What is the potential for biosimilar entry?
Biosimilar development is currently limited due to the complexity of biologic manufacturing and patent protections. No biosimilars are commercially available yet.

4. What are the key unmet needs WIGRAINE could address?
Expanding indications to other headache disorders and developing formulations with less frequent dosing could improve patient compliance.

5. Which markets offer the most growth potential for WIGRAINE?
Emerging markets with increasing healthcare access and unmet migraine treatment needs present long-term expansion opportunities.


References

[1] IDT. (2021). Global CGRP antagonist market report. International Data Corporation.
[2] U.S. Food and Drug Administration. (2018). FDA approves Emgality for migraine prevention.
[3] Eli Lilly. (2022). Emgality prescribing information.

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