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Last Updated: February 8, 2025

Erenumab-aooe - Biologic Drug Details


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Summary for erenumab-aooe
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
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. General brand-side disclosures
  4. 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.

  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 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 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 Company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 11,407,838 Company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 11,466,090 Company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 9,102,731 2029-12-18 Company disclosures
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 9,862,771 2035-06-26 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for Erenumab-aooe (Aimovig)

Introduction

Erenumab-aooe, marketed as Aimovig, is a groundbreaking biologic drug that has revolutionized the treatment of migraines. Approved by the FDA in May 2018, it is the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R)[3].

Market Entry and Initial Impact

Aimovig's approval marked the beginning of a new era in migraine prevention. Developed by Amgen and Novartis, it was predicted to achieve blockbuster status, with initial forecasts suggesting sales of $1.170 billion by 2022, which later increased to $1.426 billion[2].

Pricing Strategy

The U.S. list price of Aimovig was set at $6,900 annually, which is $575 per month for the 70 mg or 140 mg single-use prefilled SureClick autoinjector. This pricing was lower than the anticipated $10,000, helping to capture a significant market share quickly before competitors entered the market[2][3].

Competitive Landscape

Aimovig faced competition from other CGRP inhibitors, such as Eli Lilly’s galcanezumab and Teva’s fremanezumab. However, Aimovig's first-to-market advantage gave it a significant edge. By 2022, forecasts for galcanezumab and fremanezumab were much lower, at $630 million and $960 million, respectively[2].

Clinical Efficacy and Safety

Clinical trials, including a five-year open-label treatment period, demonstrated Aimovig's efficacy in reducing monthly migraine days (MMD) and the use of acute migraine-specific medications. The safety profile was consistent over five years, with no increase in adverse event rates[1].

Head-to-Head Studies

A randomized, double-blind, head-to-head study comparing Aimovig to topiramate, a commonly prescribed medication for migraine prevention, showed that Aimovig had a lower discontinuation rate due to adverse events and superior efficacy in reducing MMDs[4].

Patient Access and Support

To ensure patient access, Amgen and Novartis created the Aimovig Ally™ product support program. This program helps patients navigate insurance coverage and identifies potential access resources for those who are uninsured or underinsured[3].

Health Economic Value

Studies have shown that Aimovig is cost-effective across various patient populations. The incremental cost-effectiveness ratio (ICER) analysis indicated that Aimovig is less costly and more effective compared to other preventive treatments, such as onabotulinumtoxinA, especially for patients who have failed prior preventive therapies[5].

Market Performance and Sales

Since its launch, Aimovig has performed well in the market. The drug's ability to provide sustained reductions in MMD and its convenient once-monthly administration have contributed to its success. Despite initial concerns over pricing, the lower-than-expected list price helped in rapid market penetration[2][3].

Regulatory and Reimbursement Challenges

Aimovig, like other biologic drugs, faces regulatory, clinical, and reimbursement challenges. Pricing pressure, political and public scrutiny, and reimbursement policies imposed by third-party payers can affect sales. However, the drug's proven efficacy and safety have helped in securing favorable reimbursement policies in many regions[1][3].

Future Outlook

Given its strong clinical profile and market performance, Aimovig is expected to continue dominating the migraine prevention market. As more patients and healthcare providers become aware of its benefits, the demand for Aimovig is likely to increase. However, the drug will need to navigate ongoing competition from other CGRP inhibitors and potential biosimilars in the future[2].

Key Takeaways

  • First-to-Market Advantage: Aimovig's early approval gave it a significant edge in the market.
  • Clinical Efficacy: The drug has shown sustained reductions in MMD and superior safety compared to traditional treatments.
  • Pricing Strategy: The lower-than-anticipated list price helped in rapid market capture.
  • Competitive Landscape: Aimovig faces competition but remains a leader due to its first-to-market advantage and strong clinical data.
  • Health Economic Value: Aimovig is cost-effective and offers better outcomes compared to other preventive treatments.

FAQs

Q: What is Aimovig, and how does it work? A: Aimovig (erenumab-aooe) is a biologic drug that prevents migraines by blocking the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine pathophysiology[3].

Q: How is Aimovig administered? A: Aimovig is self-administered once monthly via the SureClick autoinjector, similar to an insulin pen[3].

Q: What are the common adverse events associated with Aimovig? A: The most common adverse events of Aimovig are injection-site reactions and constipation, with a discontinuation rate of 2% due to adverse events[2].

Q: How does Aimovig compare to other migraine preventive treatments? A: Aimovig has shown superior efficacy and a lower discontinuation rate compared to topiramate in head-to-head studies[4].

Q: What is the cost-effectiveness of Aimovig? A: Aimovig is cost-effective across various patient populations, offering better outcomes and lower costs compared to other preventive treatments like onabotulinumtoxinA[5].

Sources

  1. Amgen Announces Five-Year Data That Reinforce The Safety And Efficacy Profile Of Aimovig (erenumab-aooe) In Adult Patients With Episodic Migraine - Amgen Press Release.
  2. FDA approval of first-in-class Aimovig set to transform the migraine market - Clarivate Blog.
  3. FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention - PR Newswire.
  4. First And Only Randomized, Double-blind, Head-to-Head Study Comparing Aimovig (erenumab-aooe) An Anti-CGRP Pathway Therapy To Topiramate Published In Cephalalgia - PR Newswire.
  5. Health Economic Value of Aimovig® (erenumab-aooe) in the Preventive Treatment of Migraine - West Virginia Department of Health and Human Resources.

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