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Praluent

alirocumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Praluent

Proper name

alirocumab

Licence type

351(a)

BLA number

125559

Applicant

Regeneron Pharmaceuticals, Inc.

Center

CDER

Presentations

4

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
150MG/ML	Injection	Subcutaneous	Autoinjector	Rx	July 24, 2015
150MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	July 24, 2015
75MG/ML	Injection	Subcutaneous	Autoinjector	Rx	July 24, 2015
75MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	July 24, 2015

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	April 1, 2028

Sources for this page

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