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Eylea

aflibercept

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Eylea

Proper name

aflibercept

Licence type

351(a)

BLA number

125387

Applicant

Regeneron Pharmaceuticals, Inc.

Center

CDER

Presentations

2

First licensure

November 18, 2011

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
2MG/0.05ML	Injection	Intravitreal	Single-Dose Vial	Rx	November 18, 2011
2MG/0.05ML	Injection	Intravitreal	Pre-Filled Syringe	Rx	August 16, 2018

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 8, 2030

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity