Fremanezumab-vfrm - Biologic Drug Details

Summary for fremanezumab-vfrm

Tradenames:	1
High Confidence Patents:	3
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 fremanezumab-vfrm Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fremanezumab-vfrm 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
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089		2026-11-02	DrugPatentWatch analysis and company disclosures
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089		2031-07-11	DrugPatentWatch analysis and company disclosures
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089		2035-03-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for fremanezumab-vfrm 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 fremanezumab-vfrm

Country	Patent Number	Estimated Expiration
Georgia, Republic of	P20115333
European Patent Office	3842458
Japan	6892891
Norway	344099
Hungary	E036940
Serbia	20080200

Supplementary Protection Certificates for fremanezumab-vfrm

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1990038-0	Sweden		PRODUCT NAME: FREMANEZUMAB; REG. NO/DATE: EU/1/19/1358 20190401
PA2019015,C2380592	Lithuania		PRODUCT NAME: FREMANEZUMABAS; REGISTRATION NO/DATE: EU/1/19/1358 20190328
689	Finland
LUC00126	Luxembourg		PRODUCT NAME: FREMANEZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/19/1358 20190401
122019000041	Germany		PRODUCT NAME: GALCANEZUMAB; REGISTRATION NO/DATE: EU/1/18/1330 20181114
LUC00119	Luxembourg		PRODUCT NAME: GALCANEZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/18/1330 20181116

Market Dynamics and Financial Trajectory for Fremanezumab-vfrm: A Comprehensive Analysis

Last updated: September 7, 2025

Introduction

Fremanezumab-vfrm, marketed under the brand name Ajovy, is a monoclonal antibody developed by Teva Pharmaceuticals for the preventive treatment of migraine. As part of the burgeoning class of biologics targeting migraine pathophysiology, fremanezumab-vfrm exemplifies evolving therapeutic strategies and presents significant commercial potential. This report evaluates the current market dynamics and projects the financial trajectory of fremanezumab-vfrm within the broader migraine prophylaxis landscape.

Market Overview of Migraine Therapeutics

Migraine affects approximately 15% of the global population, translating into over one billion individuals worldwide, with chronic migraine impacting an estimated 1.4-2.7% of the population (1). Historically, treatments included traditional oral prophylactics such as beta-blockers, antidepressants, and antiepileptic drugs, which often possess suboptimal efficacy and tolerability.

The advent of biologic therapies, especially calcitonin gene-related peptide (CGRP) monoclonal antibodies, revolutionized preventive migraine management. The CGRP pathway is implicated centrally in migraine pathogenesis, making it a prime target for novel therapies (2).

Fremanezumab-vfrm: Therapeutic Profile

Fremanezumab-vfrm is a fully humanized IgG2 monoclonal antibody that binds calcitonin gene-related peptide (CGRP), preventing its activation of the receptor. Its FDA approval in 2018 for both episodic and chronic migraine positions it as a potent preventive agent. The drug is administered subcutaneously quarterly or monthly, offering convenience over oral therapies.

Market Dynamics Influencing Fremanezumab-vfrm

1. Competitive Landscape

Fremanezumab-vfrm faces competition from other CGRP monoclonal antibodies: erenumab (Aimovig), galcanezumab (Emgality), and eptinezumab (Vyepti). Each competitor varies in administration frequency, efficacy, and payer acceptance. The combined CGRP class has rapidly gained market share, owing to their superior efficacy and tolerability compared to traditional preventives (3).

2. Pricing and Reimbursement

Pricing strategies for fremanezumab-vfrm align with other biologics, with US list prices around $575 per month for monthly injections and a decreased cost for quarterly dosing (4). Reimbursement by insurers and pharmacy benefit management influences its market penetration, with formulary inclusion vital for accessibility.

3. Prescriber and Patient Acceptance

Physician familiarity and comfort with biologic therapies relative to traditional preventives have accelerated prescribing. Patient preference for less frequent injections further enhances adoption. However, some providers remain cautious regarding long-term safety and cost-effectiveness.

4. Regulatory and Market Expansion

Post-approval, fremanezumab-vfrm has received approval for additional indications, including for pediatric and adolescent populations in certain regions. Expansion into new geographic markets and underserved populations enhances potential revenues.

5. COVID-19 Impact

The pandemic temporarily disrupted outpatient services and prescribing patterns but ultimately accelerated the awareness of self-administered biologics, including fremanezumab-vfrm, as a viable outpatient therapy (5). Telemedicine adoption also facilitated ongoing patient management.

Financial Trajectory Analysis

1. Historical Revenue Performance

Since its launch, fremanezumab-vfrm has exhibited a strong growth trajectory. In Teva's 2021 annual report, the migraine preventive franchise, including Ajovy, contributed significantly to net sales. The drug’s revenue growth reflects increasing physician adoption and expanding indications.

2. Market Penetration and Growth Drivers

Projected growth hinges on several factors:

• Efficacy Data: Ongoing and emerging studies demonstrate fremanezumab's comparable efficacy across patient subgroups, reinforcing its role as a first-line preventive (6).

• Market Penetration: Current estimates suggest that only 10-15% of eligible migraine patients are on CGRP monoclonal antibodies, indicating significant room for growth (7).

• Pipeline and Line-Expansion: Potential for combination therapy studies and expanded indications could catalyze additional sales.

• Pricing and Discounting Strategies: Discounting, patient assistance programs, and biosimilar developments could impact revenues.

3. Challenges and Risks

Market saturation, generic competition from small molecules, and payer reimbursement hurdles may constrain revenue growth. Potential safety concerns or adverse event reports could influence prescriber confidence and sales.

4. Forecasted Revenue Trajectory

Analysts project that fremanezumab-vfrm will witness a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, driven by increased market acceptance and geographic expansion (8). By 2025, global sales could exceed $2 billion, assuming a steady escalation in prescription volume and sustained reimbursement policies.

Influence of External Factors

• Healthcare Policy: The adoption of value-based care models and pricing negotiations in markets such as the US and Europe will directly influence profitability.

• Market Entrants: Innovation by competitors or emergence of oral CGRP antagonists could erode market share.

• Patient Preference Trends: Growing preference for outpatient, self-administered treatments bolsters fremanezumab-vfrm's market position.

Concluding Perspectives

Fremanezumab-vfrm stands at the nexus of a transformative era in migraine therapy, with solid market potential driven by clinical efficacy, patient convenience, and expanding indications. Strategic positioning—focusing on reimbursement negotiations, expanding patient access, and demonstrating cost-effectiveness—will be critical to optimizing its financial trajectory.

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Key Takeaways

• Fremanezumab-vfrm is a leading CGRP monoclonal antibody with significant growth potential in migraine prophylaxis.
• Its market success hinges on competitive positioning, reimbursement strategies, and expanding indications.
• The growing awareness and acceptance of biologics foster increased prescribing, supporting projected double-digit revenue growth.
• Challenges include pricing pressures, market saturation, and emerging competitive therapies.
• Strategic efforts focusing on broadening access and demonstrating economic value will enhance long-term financial performance.

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FAQs

1. How does fremanezumab-vfrm compare to other CGRP inhibitors in efficacy?
Fremanezumab-vfrm has demonstrated comparable efficacy to other CGRP monoclonal antibodies like erenumab and galcanezumab in reducing migraine days, with similar safety profiles (6). Choice often depends on dosing frequency and patient preference.

2. What factors could restrict fremanezumab-vfrm’s market growth?
Market growth could be limited by payer reimbursement restrictions, low adoption rates among physicians unfamiliar with biologics, and competition from oral CGRP receptor antagonists under development or approval.

3. How does pricing influence fremanezumab-vfrm’s adoption?
Pricing significantly impacts insurance coverage and patient out-of-pocket costs. High prices may restrict access, while discounts and patient assistance programs can promote broader utilization.

4. Are there upcoming regulatory approvals that could enhance fremanezumab-vfrm’s market?
Yes. Approvals for additional indications or in new geographic markets, particularly in pediatric populations or for chronic migraine in emerging regions, could substantially increase revenues.

5. What is the long-term safety outlook for fremanezumab-vfrm?
Long-term safety data remains favorable, with birth defect surveillance and ongoing post-marketing studies continuing to support its safety profile. However, vigilance for rare adverse events remains essential.

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Sources:

[1] Goadsby PJ, et al. "Migraine pathophysiology." Annu Rev Pathol. 2017;12:373-389.
[2] Edvinsson L. "The CGRP pathway in migraine as a target for new drugs." Nat Rev Neurol. 2017;13(4):173-182.
[3] Goadsby PJ, et al. "Efficacy and safety of fremanezumab for the preventive treatment of migraine." N Engl J Med. 2018;378(22):2113-2122.
[4] Teva Pharmaceuticals. "Ajovy (fremanezumab-vfrm) prescribing information." 2022.
[5] Kaye AD, et al. "The impact of the COVID-19 pandemic on healthcare provision for migraine patients." Headache. 2021;61(4):583-591.
[6] Silberstein SD, et al. "Efficacy of fremanezumab for prevention of episodic migraine: a randomized clinical trial." JAMA. 2017;318(4):338-350.
[7] Lipton RB, et al. "Migraine prevalence, burden, and health-care utilization: a population-based study." Headache. 2015;55(10):1484-1494.
[8] MarketWatch. "Forecast: migraine medication market to reach $4 billion by 2025." 2022.