On this page

Alprolix

Coagulation Factor IX (Recombinant), Fc Fusion Protein

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Alprolix

Proper name

Coagulation Factor IX (Recombinant), Fc Fusion Protein

Licence type

351(a)

BLA number

125444

Applicant

Bioverativ Therapeutics, Inc.

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1000IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 28, 2014
2000IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 28, 2014
250IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 18, 2016
3000IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 28, 2014
4000IU	For Injection	Intravenous	Single-Dose Vial	Rx	July 14, 2016
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 28, 2014

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 28, 2021

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