Vaxelis Purple Book BLA 125563

BLA number: 125563
Proprietary names: Vaxelis
Proper names: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine
Applicant: MSP Vaccine Company
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	Vaxelis	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine	351(a)	0.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	Licensed	2018-12-21
002	Vaxelis	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine	351(a)	0.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2020-09-25

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
50090-7542	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	A-S Medication Solutions	current
63361-243	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine	MSP Vaccine Company	current
63361-245	VAXELIS	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine	MCM Vaccine Co.	legacy

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
VAXELIS	MSP Vaccine Company \| Sanofi Vaccines Canada Ltd. \| Sanofi Winthrop Industrie \| Merck Sharp & Dohme Corp.	2026-04-28
VAXELIS	MSP Vaccine Company \| Sanofi Vaccines Canada Ltd. \| Sanofi Winthrop Industrie \| Merck Sharp & Dohme Corp.	2026-03-18
VAXELIS	MSP Vaccine Company \| Sanofi Pasteur Limited \| Sanofi Winthrop Industrie \| Merck Sharp & Dohme LLC	2025-11-12
VAXELIS	A-S Medication Solutions	2025-05-13
VAXELIS	MCM Vaccine Co. \| Sanofi Pasteur Limited \| Sanofi Pasteur SA \| Merck Sharp & Dohme Corp.	2020-04-07

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-05-01	U	001	Vaxelis	351(a)	Rx	MSP Vaccine Company
2026-04-01	U	001	Vaxelis	351(a)	Disc	MSP Vaccine Company
2025-07-01	U	002	Vaxelis	351(a)	Rx	MSP Vaccine Company
2022-01-01	U	001	Vaxelis	351(a)	Rx	MSP Vaccine Company
2021-05-01	U	001	Vaxelis	351(a)	Rx	MCM Vaccine Company
2020-08-01	R	001	Vaxelis	351(a)	Rx	MCM Vaccine Company

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2026-05-01	001	Vaxelis	351(a)	Rx	Licensed	2018-12-21
2026-04-01	001	Vaxelis	351(a)	Disc	Licensed	2018-12-21
2025-07-01	002	Vaxelis	351(a)	Rx	Licensed	2020-09-25
2022-01-01	001	Vaxelis	351(a)	Rx	Licensed	2018-12-21
2020-08-01	001	Vaxelis	351(a)	Rx	Licensed	2018-12-21