Erenumab-aooe - Biologic Drug Details

Summary for erenumab-aooe

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

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

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.

2. DrugPatentWatch analysis and brand-side disclosures

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.

3. Patents from broad patent text search

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 erenumab-aooe Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for erenumab-aooe 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

3) Low Certainty: US Patents for erenumab-aooe Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

International Patents for erenumab-aooe

Country	Patent Number	Estimated Expiration
Slovenia	3285803
Russian Federation	2707745
Serbia	56567
Lithuania	PA2018017
Cyprus	1123211

Supplementary Protection Certificates for erenumab-aooe

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2018017,C2379594	Lithuania		PRODUCT NAME: ERENUMABAS; REGISTRATION NO/DATE: EU/1/18/1293 20180726
2018042	Norway		PRODUCT NAME: ERENUMAB; REG. NO/DATE: 20180730
C201830059	Spain		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		PRODUCT NAME: ERENUMAB; REGISTRATION NO/DATE: EU/1/18/1293 (MITTEILUNG) 20180730
300961	Netherlands		PRODUCT NAME: ERENUMAB; REGISTRATION NO/DATE: EU/1/18/1293 20170730

Market Dynamics and Financial Trajectory for the Biologic Drug: Erenumab-aooe

Last updated: July 27, 2025

Introduction

Erenumab-aooe, marketed under the brand name Aimovig, represents a significant breakthrough in migraine prophylaxis, marking a new chapter in biologic therapeutics. Approved by the U.S. Food and Drug Administration (FDA) in 2018, this monoclonal antibody targets the calcitonin gene-related peptide (CGRP) receptor, reducing migraine frequency in chronic and episodic sufferers. Its emergence has reshaped the landscape of headache management, integrating biologics into mainstream treatment paradigms. This report analyzes the evolving market dynamics and financial trajectory of erenumab-aooe, contextualizing its growth within broader pharmaceutical industry trends.

Market Landscape and Drivers

Growing Prevalence of Migraine

Migraine affects over 1 billion individuals globally, with approximately 12% of the population experiencing episodic migraines and 2-3% suffering from chronic migraine disorders [1]. The substantial patient population fuels demand for effective preventive treatments. Traditional prophylaxis options, including beta-blockers, anticonvulsants, and antidepressants, often result in suboptimal efficacy and adverse effects, creating a market gap.

Introduction of Targeted Biologic Therapies

Erenumab-aooe introduced a novel mechanism targeting the CGRP pathway — a key mediator in migraine pathophysiology. Its approval catalyzed the development and eventual market entry of other CGRP inhibitors, such as fremanezumab, galcanezumab, and eptinezumab, fostering intensified competition and accelerating market expansion [2].

Regulatory Approvals and Reimbursement Policies

The rapid regulatory acceptance of erenumab-aooe, along with favorable reimbursement policies in the U.S. and select markets, contributed to its early adoption among neurologists and headache clinics. The inclusion in key clinical guidelines has further legitimized its use. Current policies increasingly favor biologic therapies due to their targeted action and improved safety profiles, reinforcing sustained demand [3].

Market Dynamics

Competitive Landscape

Erenumab-aooe retains a leadership position as the first CGRP receptor antagonist. The entry of rival biologics has fragmented the market but also stimulated innovation. While the competitors offer similar efficacy, differential dosing schedules, patient tolerability, and insurance coverage influence prescribing patterns.

Pricing and Market Penetration

Initial pricing hovered around $575 monthly in the U.S., positioning erenumab-aooe as a premium therapy. Payers' negotiations and the prospect of long-term cost savings via reduced healthcare utilization have gradually improved coverage. Market penetration has been robust, especially among high-frequency and refractory migraine sufferers, where clinical benefits are most pronounced.

Patient and Provider Adoption

Physicians increasingly recommend erenumab-aooe for prophylaxis due to its favorable safety profile and ease of administration (monthly subcutaneous injections). Patients preferred the biologic over oral preventives due to minimal drug interactions and tolerability. The COVID-19 pandemic, despite initial disruptions, highlighted the convenience of self-injection, supporting continued adoption [4].

Market Challenges

Despite positive momentum, hurdles persist. High medication costs, insurance denials, and the need for long-term safety data temper growth trajectories. Additionally, some patient populations are hesitant due to concerns over immunogenicity or unknown long-term effects.

Financial Trajectory and Revenue Projections

Initial Sales Performance

In its launch year (2018), erenumab-aooe registered approximately $500 million in global sales, primarily driven by the U.S. market. Growth was fueled by expanding indications, including episodic and chronic migraine, and increasing prescriber familiarity.

Market Growth and Forecasts

Projections estimate the global market for CGRP inhibitors to reach upwards of $4 billion annually by 2025, with erenumab accounting for a significant share. The compound annual growth rate (CAGR) from 2020 to 2025 is anticipated to be around 15-20%, driven by expanding indications, increased patient access, and ongoing pipeline developments.

Geographical Expansion

U.S. sales dominate, but emerging markets in Europe, Asia-Pacific, and Latin America show substantial growth potential owing to rising migraine awareness, improved healthcare infrastructure, and generic biosimilars anticipated in the future.

Pipeline Enhancements and Lifecycle Management

Boehringer Ingelheim’s future plans involve developing extended formulations and combination therapies. The pharmaceutical company's pipeline expansion aims to sustain revenue streams while countering generic erosion of earlier molecules. Additionally, real-world evidence demonstrating cost-effectiveness and improved quality of life will likely facilitate broader insurance coverage, bolstering sales.

Revenue and Cost Considerations

Pricing Strategies

Pharmaceutical companies have employed tiered pricing and outcome-based reimbursement models to optimize revenue. With increased competition, prices may decline, but premium positioning remains viable due to clinical advantages.

Market Penetration and Heightened Competition

While erenumab continues to dominate the CGRP class, the emergence of oral small-molecule CGRP antagonists (gepants) and potential biosimilars could exert downward pressure on pricing and margins. Nevertheless, the biologic's reputation and proven efficacy confer a durable competitive advantage.

Cost-Benefit Dynamics

Payers are increasingly evaluating the long-term cost reductions from decreased emergency visits, hospitalizations, and medication overuse headaches. Demonstrating value via pharmacoeconomic analyses is pivotal for maintaining favorable reimbursement terms.

Conclusion

Erenumab-aooe’s ascent reflects strategic innovation, targeted therapy benefits, and shifting treatment paradigms in migraine management. While its market journey balances growth opportunities with competitive and economic challenges, it exemplifies the transformative potential of biologic drugs. Expect continued expansion, guided by evolving clinical evidence, patient preferences, and healthcare policies.

---

Key Takeaways

• The global migraine market, driven by high prevalence and unmet needs, positions erenumab-aooe as a cornerstone biologic in preventive therapy.
• Market expansion is fostered by regulatory approvals, differentiated efficacy, favorable safety profiles, and positive clinical guidelines.
• Revenue growth relies on expanding indications, geographic penetration, and evolving payer landscapes, with projections exceeding $4 billion globally by 2025.
• Competition from emerging biologics and biosimilars poses pricing and market share pressures, but erenumab’s established efficacy sustains its leadership.
• Strategic engagement with payers, continuous clinical milestone achievements, and pipeline innovations are critical to optimizing long-term financial success.

---

FAQs

1. What factors influence the pricing of erenumab-aooe?
Pricing is affected by manufacturing costs, clinical efficacy, competitive positioning, payer negotiations, and the overall value proposition in healthcare cost savings.

2. How does insurance coverage impact erenumab’s market penetration?
Insurance policies significantly influence patient access; favorable coverage enhances adoption, while denials or high copays hinder it.

3. Are there biosimilars of erenumab-aooe in development?
As of now, biosimilars are not available, but pipeline products and potential alternative biologics might enter the market in the coming years, affecting future pricing and competition.

4. What are the primary concerns regarding the long-term safety of erenumab?
Long-term safety data are still accruing; potential concerns include immunogenicity or unforeseen adverse effects, but current evidence supports a favorable safety profile.

5. How does erenumab compare with oral CGRP antagonists?
While oral gepants offer convenience and potentially lower costs, erenumab’s established efficacy, especially in refractory cases, and its long safety profile position it as a preferred choice in specific patient populations.

---

Sources

[1] GBD 2019 Country and Territory-Level Disease Burden Data. Global Burden of Disease Study.
[2] Edvinsson, L. et al. “CGRP antagonists in migraine: The segment on emerging therapies.” Lancet Neurology. 2020.
[3] FDA Approvals and Guidelines. U.S. Food & Drug Administration.
[4] Blumenfeld, A. et al. “Impact of COVID-19 on migraine management: Emerging challenges and solutions.” Cephalalgia. 2021.