Aralast, Aralast Np Purple Book BLA 125039

BLA number: 125039
Proprietary names: Aralast, Aralast Np
Proper names: Alpha-1-Proteinase Inhibitor (Human)
Applicant: Takeda Pharmaceuticals U.S.A., Inc.
Center: CBER
First observed release: 2020-08-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Aralast, Aralast Np	Alpha-1-Proteinase Inhibitor (Human)	351(a)	0.5G	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2002-12-23
002	Aralast, Aralast Np	Alpha-1-Proteinase Inhibitor (Human)	351(a)	1.0G	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2002-12-23

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
0944-2814	Aralast	Alpha-1-Proteinase Inhibitor (Human)	Takeda Pharmaceuticals America, Inc.	current
0944-2815	Aralast	Alpha-1-Proteinase Inhibitor (Human)	Takeda Pharmaceuticals America, Inc.	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Aralast NP	Takeda Pharmaceuticals America, Inc. \| Takeda Manufacturing Austria AG \| Siegfried Hameln GmbH	2025-11-25
Aralast NP	Takeda Pharmaceuticals America, Inc. \| Takeda Manufacturing Austria AG \| Siegfried Hameln GmbH	2025-09-01

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2023-05-01	U	001	Aralast, Aralast Np	351(a)	Rx	Takeda Pharmaceuticals U.S.A., Inc.
2023-05-01	U	002	Aralast, Aralast Np	351(a)	Rx	Takeda Pharmaceuticals U.S.A., Inc.
2021-05-01	U	001	Aralast, Aralast Np	351(a)	Rx	Baxalta US Inc.
2021-05-01	U	002	Aralast, Aralast Np	351(a)	Rx	Baxalta US Inc.
2020-08-01	R	001	Aralast, Aralast Np	351(a)	Rx	Baxalta US Inc.
2020-08-01	R	002	Aralast, Aralast Np	351(a)	Rx	Baxalta US Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-08-01	001	Aralast, Aralast Np	351(a)	Rx	Licensed	2002-12-23
2020-08-01	002	Aralast, Aralast Np	351(a)	Rx	Licensed	2002-12-23