Purple Book product · Reference 351(a)

Remicade

infliximab

351(a)BLA 103772RxLicensed Janssen Biotech, Inc.

View infliximab family Label PDF Open on FDA Purple Book

Aug 24, 1998

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Remicade (infliximab) is Janssen Biotech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 1998. 4 approved follow-on biologics reference Remicade (Inflectra, Renflexis, Ixifi, and Avsola).

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Aug 24, 1998
28 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Sep 23, 2018
7 yr 11 mo ago
Today

Pharmaceutical detail

Strength

100MG

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1864

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

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Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Remicade have approved biosimilars?

Yes. 4 approved follow-on biologics reference Remicade in the Purple Book: Inflectra, Renflexis, Ixifi, and Avsola.

What is Remicade's BLA number?

Remicade is licensed under BLA 103772, held by Janssen Biotech, Inc..

When was Remicade approved by the FDA?

Remicade was approved by the FDA on Aug 24, 1998.

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