Ahzantive® (aflibercept-mrbb)

aBL 761378

Ahzantive® (aflibercept-mrbb)

aBL 761378

U.S. License Holder:

Formycon / Klinge Biopharma

Date of License:

June-28-2024

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

AHZANTIVE (aflibercept-mrbb) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD);

Macular Edema Following Retinal Vein Occlusion (RVO);

Diabetic Macular Edema (DME);

Diabetic Retinopathy (DR).

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2025-00233

U.S. Patent No.
11,084,865 (VEGF Antagonist Formulations Suitable for Intravitreal Administration)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Formycon AG

§ 102 Challenge
N

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-12, 14-17, 19-20, 22-36, 39-42, 44-45, 47-55

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Awaiting Institution Decision; Motion for Joinder

IPR Status
Awaiting Institution Decision; Motion for Joinder with IPR2025-00176

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)

U.S. Patent Nos.
7,070,959 (Modified Chimeric Polypeptides with Improved Pharmacokinetic Properties) 7,771,997 (Enhanced Expression and Stability Regions) 9,222,106 (Enhanced Expression and Stability Regions) 9,254,338 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 9,562,238 (Enhanced Expression and Stability Regions) 9,816,110 (CHO Integration Sites and Uses Thereof) 9,932,605 (Enhanced Expression and Stability Regions) 10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,415,055 (Enhanced Expression and Stability Regions) 10,464,992 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 10,669,594 (Compositions and Methods for Detecting a Biological Contaminant) 10,828,345 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,888,601 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,927,342 (Taurine Supplemented Cell Culture Medium and Methods of Use) 11,053,280 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,066,458 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,084,865 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,104,715 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,174,283 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,253,572 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,268,109 (CHO Integration Sites and Uses Thereof) 11,299,532 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,306,135 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,312,936 (Taurine Supplemented Cell Culture Medium and Methods of Use) 11,332,771 (Serum-Free Cell Culture Medium) 11,472,861 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,485,770 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,535,663 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,542,317 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,548,932 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,549,154 (Compositions and Methods for Detecting a Biological Contaminant) 11,555,176 (Cell Culture Medium for Eukaryotic Cells) 11,559,564 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,680,930 (Methods and Systems for Chromatography Data Analysis) 11,707,506 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,732,024 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,753,459 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,769,597 (Methods of Associating Genetic Variants with a Clinical Outcome in Patients Suffering from Age-Related Macular Degeneration Treated with Anti-VEGF) 11,788,102 (CHO Integration Sites and Uses Thereof)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Formycon AG

Federal Circuit Appeal(s)
Preliminary Injunction: 24-2009 (lead), 24-2019 (consolidated), 24-2156 (consolidated)

Status
Case Ongoing, Preliminary Injunction Granted, Federal Circuit Appeals Ongoing

BPCIA
Y

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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