Enzeevu (aflibercept-abzv)

aBL 761382

Enzeevu (aflibercept-abzv)

aBL 761382

U.S. License Holder:

Sandoz Inc.

Date of License:

August-09-2024 (Provisionally Interchangeable)

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications


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

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

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Afqlir® (Sandoz) (November-2024)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
9,222,106 (Enhanced Expression and Stability Regions) 9,315,281 (System and Methods for Use in Dispensing Biopharmaceutical Materials) 9,816,110 (CHO Integration Sites and Uses Thereof) 10,182,969 (Aseptic Piercing System and Method) 10,415,055 (Enhanced Expression and Stability Regions) 10,669,594 (Compositions and Methods for Detecting a Biological Contaminant) 10,828,345 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,905,786 (Sterilisation Method) 10,918,754 (Sterilisation Method) 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) 11,160,918 (Medical Device Packaging and Related Methods) 11,174,283 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,268,109 (CHO Integration Sites and Uses Thereof) 11,299,532 (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) 11,406,565 (Aseptic Piercing System and Method) 11,433,186 (Devices and Methods for Precision Dose Delivery) 11,439,758 (Devices and Methods for Precision Dose Delivery) 11,459,373 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,459,374 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,472,861 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,478,588 (Needle Shield Grip Devices and Related Methods) 11,535,663 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,548,932 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,555,176 (Cell Culture Medium for Eukaryotic Cells) 11,577,025 (Devices and Methods for Overfilling Drug Containers) 11,732,025 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,788,102 (CHO Integration Sites and Uses Thereof) 11,793,926 (Medical Device Packaging and Related Methods) 11,850,407 (Needle Shield Grip Devices and Related Methods) 11,918,785 (Devices and Methods for Overfilling Drug Containers) 11,970,724 (Serum-free Cell Culture Medium) 11,975,045 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) D858,754 (Syringe Cap) D906,102 (Packaging) D934,069 (Packaging) D961,376 (Packaging) D961,377 (Packaging) D1,024,321 (Retainer Adapter Assembly) D1,028,224 (Retainer Adapter Assembly) D1,035,436 (Packaging)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Sandoz Inc.

Status
Case Ongoing

BPCIA
Y

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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