Praluent Purple Book BLA 125559

BLA number: 125559
Proprietary names: Praluent
Proper names: alirocumab
Applicant: Regeneron Pharmaceuticals, Inc.
Center: CDER
First observed release: 2020-05-01
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	Praluent	alirocumab	351(a)	75MG/ML	Injection	Subcutaneous	Autoinjector	Rx	Licensed	2015-07-24
002	Praluent	alirocumab	351(a)	150MG/ML	Injection	Subcutaneous	Autoinjector	Rx	Licensed	2015-07-24
003	Praluent	alirocumab	351(a)	75MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	Licensed	2015-07-24
004	Praluent	alirocumab	351(a)	150MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	Licensed	2015-07-24

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
0024-5901	Praluent	alirocumab	Sanofi-Aventis U.S. LLC	current
0024-5902	Praluent	alirocumab	Sanofi-Aventis U.S. LLC	current
61755-020	Praluent	alirocumab	Regeneron Pharmaceuticals, Inc.	current
61755-021	Praluent	alirocumab	Regeneron Pharmaceuticals, Inc.	current
0024-5903	Praluent	alirocumab	Sanofi-Aventis U.S. LLC	legacy
0024-5904	Praluent	alirocumab	Sanofi-Aventis U.S. LLC	legacy
72733-5901	Praluent	alirocumab	Sanofi US Corporation	legacy
72733-5902	Praluent	alirocumab	Sanofi US Corporation	legacy

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Praluent	Regeneron Pharmaceuticals, Inc. \| Genzyme Ireland Limited \| Regeneron Ireland Designated Activity Company \| Eurofins Biopharma Product Testing Ireland Limited \| Eurofins BioPharma Product Testing Munich GmbH \| PPD Development Ireland Ltd \| Bioreliance Ltd. \| Advanced Therapies, LLC \| Eurofins Lancaster Laboratories, LLC \| Nelson Laboratories, LLC \| Nitto Avecia Pharma Services, Inc. \| Sanofi-Aventis Deutschland GmbH \| Sanofi Winthrop Industrie \| BioReliance Corporation \| Sanofi Vaccines US Inc.	2026-07-16
Praluent	Sanofi-Aventis U.S. LLC \| Regeneron Pharmaceuticals, Inc. \| Sanofi Winthrop Industrie \| Sanofi Vaccines US Inc. \| Regeneron Ireland Designated Activity Company \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited	2026-07-07
Praluent	Regeneron Pharmaceuticals, Inc.	2025-10-30
Praluent	Sanofi-Aventis U.S. LLC \| Regeneron Pharmaceuticals, Inc. \| Sanofi Winthrop Industrie \| Sanofi Pasteur Inc. \| Regn Ireland DAC \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited	2025-10-23
Praluent	Sanofi-Aventis U.S. LLC \| Regeneron Pharmaceuticals, Inc. \| Sanofi Winthrop Industrie \| Sanofi Pasteur Inc. \| Regn Ireland DAC \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited	2025-09-15
Praluent	Sanofi US Corporation \| Regeneron Pharmaceuticals, Inc. \| Regn Ireland DAC \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited \| Sanofi Winthrop Industrie	2024-03-08
Praluent	Regeneron Pharmaceuticals, Inc.	2024-03-08

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2022-03-01	U	001	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2022-03-01	U	002	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2022-03-01	U	003	Praluent	351(a)	Disc	Regeneron Pharmaceuticals, Inc.
2022-03-01	U	004	Praluent	351(a)	Disc	Regeneron Pharmaceuticals, Inc.
2021-07-01	U	001	Praluent	351(a)	Disc	Regeneron Pharmaceuticals, Inc.
2021-07-01	U	002	Praluent	351(a)	Disc	Regeneron Pharmaceuticals, Inc.
2021-07-01	U	003	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2021-07-01	U	004	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2021-04-01	U	001	Praluent	351(a)	Disc	Regeneron Pharmaceuticals, Inc.
2021-04-01	U	002	Praluent	351(a)	Disc	Regeneron Pharmaceuticals, Inc.
2020-05-01	R, U	001	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2020-05-01	R, U	002	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2020-05-01	R, U	003	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2020-05-01	R, U	004	Praluent	351(a)	Rx	Regeneron Pharmaceuticals, Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2022-03-01	001	Praluent	351(a)	Rx	Licensed	2015-07-24
2022-03-01	002	Praluent	351(a)	Rx	Licensed	2015-07-24
2022-03-01	003	Praluent	351(a)	Disc	Licensed	2015-07-24
2022-03-01	004	Praluent	351(a)	Disc	Licensed	2015-07-24
2021-04-01	001	Praluent	351(a)	Disc	Licensed	2015-07-24
2021-04-01	002	Praluent	351(a)	Disc	Licensed	2015-07-24
2020-05-01	001	Praluent	351(a)	Rx	Licensed	2015-07-24
2020-05-01	002	Praluent	351(a)	Rx	Licensed	2015-07-24
2020-05-01	003	Praluent	351(a)	Rx	Licensed	2015-07-24
2020-05-01	004	Praluent	351(a)	Rx	Licensed	2015-07-24