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Last Updated: December 30, 2025

Biologic Drugs With Established Pharmaceutical Class: CD38-directed Cytolytic Antibody

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Biologic Drugs With Established Pharmaceutical Class: CD38-directed Cytolytic Antibody

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	2015-11-16	⤷ Get Started Free	⤷ Get Started Free
Sanofi-aventis U.s. Llc	SARCLISA	isatuximab-irfc	Injection	761113	2020-03-02	⤷ Get Started Free	⤷ Get Started Free
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145	2020-05-01	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Patent Expiration

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