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Last Updated: December 15, 2025

AIMOVIG Drug Profile


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Summary for Tradename: AIMOVIG
Recent Clinical Trials for AIMOVIG

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Massachusetts General HospitalPhase 2
Recordati Rare DiseasesPhase 2
Chicago Headache Center & Research InstitutePhase 4

See all AIMOVIG clinical trials

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. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including 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 AIMOVIG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AIMOVIG Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 10,259,877 2036-04-22 DrugPatentWatch analysis and company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 11,407,838 2039-04-01 DrugPatentWatch analysis and company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 11,466,090 2039-02-27 DrugPatentWatch analysis and company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 9,102,731 2029-12-18 DrugPatentWatch analysis and company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 9,862,771 2035-06-26 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

No patents found based on company disclosures

Supplementary Protection Certificates for AIMOVIG

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
PA2018017,C2379594 Lithuania ⤷  Get Started Free PRODUCT NAME: ERENUMABAS; REGISTRATION NO/DATE: EU/1/18/1293 20180726
2018042 Norway ⤷  Get Started Free PRODUCT NAME: ERENUMAB; REG. NO/DATE: 20180730
C201830059 Spain ⤷  Get Started Free PRODUCT NAME: ERENUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1293; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1293; DATE OF FIRST AUTHORISATION IN EEA: 20180726
50/2018 Austria ⤷  Get Started Free PRODUCT NAME: ERENUMAB; REGISTRATION NO/DATE: EU/1/18/1293 (MITTEILUNG) 20180730
300961 Netherlands ⤷  Get Started Free PRODUCT NAME: ERENUMAB; REGISTRATION NO/DATE: EU/1/18/1293 20170730
669 Finland ⤷  Get Started Free
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Biologic Drug AIMOVIG

Last updated: September 19, 2025

Introduction

AIMOVIG (erenumab) represents a groundbreaking advancement in the treatment landscape for migraine prophylaxis. Developed by Novartis and Amgen, AIMOVIG is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, a biological pathway intricately linked to migraine pathophysiology. Since its approval in 2018 by the FDA, AIMOVIG has not only transformed clinical practice but has also become a pivotal asset within the biologic therapeutics market.

This analysis explores the evolving market dynamics and financial trajectory of AIMOVIG. It considers factors influencing its market penetration, competitive landscape, reimbursement environment, and future growth prospects within the expanding biologics segment.

Market Overview and Dynamics

Growing Burden of Migraines

Migraine affects an estimated 1 billion individuals worldwide, representing a significant unmet medical need due to limited efficacy and tolerability issues associated with traditional prophylactic agents like beta-blockers and antiepileptics [1]. The high prevalence, coupled with the substantial disability and socioeconomic burden, fuels the demand for innovative, targeted treatments such as AIMOVIG.

Regulatory Approvals and Market Entry

AIMOVIG received FDA approval in 2018 for adult migraine prevention, subsequently gaining approvals across multiple regions, including the European Union, Japan, and other markets. Its favorable safety profile and targeted mechanism have positioned it as a first-in-class biologic for migraine.

The initial launch faced initial hurdles—high cost, insurer reluctance, and competition from emerging CGRP inhibitors—yet gradually gained reimbursement approvals and clinician acceptance. The expanding label indications, including episodic and chronic migraine, further broaden its market potential.

Competitive Landscape

AIMOVIG faces competitive pressure from four other CGRP-targeting biologics:

  • Galcanezumab (Emgality) by Eli Lilly
  • Fremanezumab (Ajovy) by Teva
  • Eptinezumab (Vyepti) by Lundbeck/Alkermes
  • Eptinezumab and other emerging agents.

While all target the CGRP pathway, differences in administration routes, dosing frequency, efficacy, safety, and pricing influence market share. AIMOVIG’s unique receptor-targeting approach offers differentiated efficacy in certain subpopulations.

Pricing and Reimbursement Dynamics

AIMOVIG’s list price generally exceeds $575 per injection, with monthly treatments costing approximately $6,900. These high upfront costs pose barriers to widespread adoption, especially within cost-sensitive healthcare systems.

Reimbursement policies—dictated by payers’ willingness to cover biologics—have evolved through negotiations, prior authorization criteria, and outcomes-based agreements. Payers increasingly require demonstration of treatment failure with traditional prophylactics before approving biologics, constraining initial patient access.

Furthermore, the introduction of biosimilars remains limited for monoclonal antibodies, enabling stability in pricing and market share. However, imminent development of biosimilars and novel therapeutics could alter the competitive landscape.

Market Penetration and Adoption Trends

Initial adoption was slow due to pricing barriers but accelerated as clinical guidelines integrated AIMOVIG into standard migraine prevention, and patient awareness increased. The COVID-19 pandemic initially disrupted in-person prescribing, but telehealth adoption facilitated continuity of care.

Data from IQVIA indicates steady growth in prescriptions, with estimates suggesting that AIMOVIG captured a substantial portion of the CGRP inhibitor market by 2022, roughly accounting for 40-50% of prescriptions among CGRP class agents [2].

Pharmacoeconomic Considerations

Cost-effectiveness analyses, including QALY (Quality-Adjusted Life Year) calculations, support AIMOVIG’s placement in medicare and private insurer formularies when prescribed to appropriate patients. Nevertheless, price debates persist, especially concerning long-term cost implications compared to conventional therapies.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since its launch, AIMOVIG has demonstrated consistent revenue growth. Novartis and Amgen reported combined revenues exceeding $600 million in 2021, representing a significant segment within the biologics portfolio [3]. The growth is attributed to increasing patient adoption, expanding indications, and improved payer coverage.

Forecasted Growth Drivers

  • Expansion of Approved Indications: Recent approvals for episodic and chronic migraine enhance market scope.
  • Market Penetration in Emerging Economies: Entry into rapidly developing markets such as China, Brazil, and parts of Southeast Asia offers sizable growth opportunities.
  • Patient Access Programs: Initiatives that reduce out-of-pocket costs will expand utilization.
  • Pipeline Enhancements: Potential combination therapies and next-generation CGRP agents could supplement AIMOVIG’s market share.

Challenges and Risk Factors

  • Pricing Pressures: Payers’ push for value-based contracts and biosimilar entry threaten revenue stability.
  • Competitive Innovation: The emergence of oral CGRP antagonists (e.g., ubrogepant, rimegepant) offers alternative preventive options, potentially limiting AIMOVIG’s growth.
  • Regulatory and Reimbursement Hurdles: Variability across markets complicates global sales strategies.

Future Revenue Projections

Industry estimates project AIMOVIG’s global revenues could reach $2.5 billion to $3 billion annually by 2025, contingent on market expansion, reimbursement advancements, and clinical outcomes. Continued innovation and strategic pricing will be critical to sustain growth.

Strategic Opportunities and Market Positioning

  • Diversification of Indications: Investigating efficacy in pediatric, medication-overuse headache, and other neurovascular disorders.
  • Real-World Evidence: Leveraging post-market data to demonstrate cost-effectiveness and optimize payer negotiations.
  • Combination Therapy: Exploring synergies with acute migraine treatments to enhance patient outcomes.

Conclusion

AIMOVIG’s trajectory exemplifies the transformative potential of biologic therapeutics within neurology. While initial commercialization faced challenges, strategic positioning, clinical validation, and expanding access pathways support robust future growth. The evolving competitive environment and pricing landscape will remain pivotal to its long-term financial success.

Key Takeaways

  • AIMOVIG established itself as a leading CGRP receptor antagonist, with sustained growth driven by expanding indications and increased clinician adoption.
  • Market dynamics are heavily influenced by reimbursement strategies, price negotiations, and emerging alternatives, including oral therapeutics.
  • Revenue forecasts suggest a trajectory toward $3 billion annually by the mid-2020s, contingent on market expansion and competitive positioning.
  • Strategic emphasis on real-world evidence and pipeline development will be essential to sustain and grow its market share.
  • The biologics segment’s inherent pricing and regulatory challenges necessitate vigilant market analysis and adaptive commercial strategies.

FAQs

Q1: How does AIMOVIG compare to other CGRP inhibitors in terms of efficacy and safety?
A1: Clinical trials demonstrate comparable efficacy across CGRP inhibitors, with AIMOVIG showing a favorable safety profile. Its receptor-targeting mechanism may offer benefits in certain patient subpopulations, though differences are generally subtle.

Q2: What are the primary reimbursement barriers for AIMOVIG?
A2: High treatment costs, prior authorization hurdles, and formulary restrictions pose significant barriers, often requiring demonstration of failure with traditional therapies.

Q3: How is AIMOVIG’s market share expected to evolve with upcoming generics and biosimilars?
A3: Currently limited biosimilar activity sustains AIMOVIG’s market position. However, biosimilar entry could exert downward pricing pressure, affecting long-term revenues.

Q4: What opportunities exist for expanding AIMOVIG’s indications?
A4: Research into its efficacy in pediatric migraines, medication-overuse headache, and possibly other neurovascular conditions presents future growth avenues.

Q5: How significant is the role of patient adherence in AIMOVIG’s market performance?
A5: Its monthly injection schedule, favorable safety profile, and high tolerability support better adherence, which correlates with improved outcomes and sustained market growth.


Sources:

[1] Global Burden of Disease Study – Migraine Prevalence and Impact.
[2] IQVIA Prescription Data (2022).
[3] Novartis & Amgen 2021 Annual Reports.

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