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Last Updated: March 16, 2025

Biologic Drugs With Established Pharmaceutical Class: Inactivated Hepatitis B Virus Vaccine

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Biologic Drugs With Established Pharmaceutical Class: Inactivated Hepatitis B Virus Vaccine

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration

Merck Sharp & Dohme Corp.	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	1986-07-23	⤷ Try for Free	⤷ Try for Free
Dynavax Technologies Corporation	HEPLISAV-B	hepatitis b vaccine (recombinant), adjuvanted	Injection	125428	2017-11-09	⤷ Try for Free	⤷ Try for Free
Mcm Vaccine Company	VAXELIS	diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine	Injection	125563	2018-12-21	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Patent Expiration

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