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Mallinckrodt
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Last Updated: September 25, 2021

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EYLEA Drug Profile


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UNDER DEVELOPMENT

Which patents cover Eylea, and when can biosimilar versions of Eylea launch?

Eylea is a drug marketed by Regeneron Pharmaceuticals and is included in one BLA.

The biologic ingredient in EYLEA is aflibercept. A full profile is posted on the aflibercept profile page.

DrugPatentWatch® Biosimilar and Interchangeable Outlook for Eylea

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in biosimilar launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Biosimilar Launch

Under Development

  Try it Free

Summary for Tradename: EYLEA
Recent Litigation for EYLEA

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc.2020-06-19
Regeneron Pharmaceuticals, Inc. v. Genentech, Inc.2011-02-17

See all EYLEA litigation

PTAB Litigation
PetitionerDate
Regeneron Pharmaceuticals, Inc.2021-04-16
Regeneron Pharmaceuticals, Inc.2020-07-16

See all EYLEA litigation

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 EYLEA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for EYLEA Derived from Company Disclosures

These patents were extracted from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18 ⤷  Try it Free Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) 2019-06-08 RX company
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18 ⤷  Try it Free Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) 2039-02-26 RX company
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18 ⤷  Try it Free Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) 2039-02-26 RX company
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18 ⤷  Try it Free Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) 2039-03-29 RX company
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18 ⤷  Try it Free Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) 2019-06-08 RX company
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18 ⤷  Try it Free Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) 2019-06-08 RX company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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

These patents were identified by searching patent claims

Supplementary Protection Certificates for EYLEA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C01183353/01 Switzerland ⤷  Try it Free PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: SWISSMEDIC 62397 29.10.2012
92195 Luxembourg ⤷  Try it Free PRODUCT NAME: AFLIBERCEPT (EYLEA - ZALTRAP)
500 Finland ⤷  Try it Free
13C0028 France ⤷  Try it Free PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001 20121122
2013C/029 Belgium ⤷  Try it Free PRODUCT NAME: AFLIBERCEPT; AUTHORISATION NUMBER AND DATE: EU/1/12/197/001 20121126
132013902154380 Italy ⤷  Try it Free PRODUCT NAME: AFLIBERCEPT(EYLEA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/797/001-002, 20121122
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Boehringer Ingelheim
McKinsey
Mallinckrodt
Merck

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