Home PurpleBook 103772 Remicade Purple Book BLA 103772
BLA number 103772
Proprietary names Remicade
Proper names infliximab
Applicant Janssen Biotech, Inc.
Center CDER
First observed release 2020-02-01
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 Remicade infliximab 351(a) 100MG For Injection Intravenous Single-Dose Vial Rx Licensed 1998-08-24
Biosimilar And Interchangeable Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125544 Inflectra infliximab-dyyb 351(k) Biosimilar Rx 2026-06-01 761054 Renflexis infliximab-abda 351(k) Biosimilar Rx 2026-06-01 761072 Ixifi infliximab-qbtx 351(k) Biosimilar Disc 2026-06-01 761086 Avsola infliximab-axxq 351(k) Biosimilar Rx 2026-06-01
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.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2020-08-01 U 001 Remicade 351(a) Rx Janssen Biotech, Inc.
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2020-05-01 001 Remicade 351(a) Rx Licensed 1998-08-24 2020-02-01 001 Remicade 351(a) Marketed Licensed 1998-08-24
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