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Dupixent

dupilumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Dupixent

Proper name

dupilumab

Licence type

351(a)

BLA number

761055

Applicant

Regeneron Pharmaceuticals, Inc.

Center

CDER

Presentations

6

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG/0.67ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	October 20, 2021
200MG/1.14ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	October 19, 2018
200MG/1.14ML	Injection	Subcutaneous	Autoinjector	Rx	June 14, 2021
300MG/2ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 28, 2017
300MG/2ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	March 28, 2017
300MG/2ML	Injection	Subcutaneous	Autoinjector	Rx	June 18, 2020

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 25, 1931

Sources for this page

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