Purple Book product · Reference 351(a)

Rituxan

rituximab

351(a)BLA 103705RxLicensed Genentech, Inc.

View rituximab family Label PDF Open on FDA Purple Book

Nov 26, 1997

Approved

Reference 351(a)

License type

Marketing

Listed patents

Rituxan (rituximab) is Genentech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 1997. The FDA Purple Book lists 15 published patents for it, the last expiring 2035. 3 approved follow-on biologics reference Rituxan (Truxima, Ruxience, and Riabni).

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

Key dates

Approval
Approval date of this BLA submission.
Nov 26, 1997
29 yr 1 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 02, 2028
in 2 yr 5 mo

Pharmaceutical detail

Strength

500MG/50ML (10MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1048

Product number

002

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.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

Patent list (15)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
7,485,704	Mar 08, 2025	1 yr 5 mo ago	FDA
7,976,838	Jun 30, 2025	1 yr 1 mo ago	FDA
10,450,379	Nov 14, 2026	in 4 mo	FDA
10,654,940	Nov 14, 2026	in 4 mo	FDA
10,759,866	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
8,460,895	Aug 08, 2029	in 3 yr 1 mo	FDA
10,982,003	Aug 06, 2030	in 4 yr 1 mo	FDA
9,714,293	Aug 06, 2030	in 4 yr 1 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 6 mo	FDA
10,662,237	Aug 07, 2031	in 5 yr 2 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 9 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,336,983	Jul 31, 2035	in 9 yr 2 mo	FDA

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

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

Frequently asked questions

When do Rituxan's patents expire?

The FDA Purple Book lists 15 published patents for Rituxan, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.

Does Rituxan have approved biosimilars?

Yes. 3 approved follow-on biologics reference Rituxan in the Purple Book: Truxima, Ruxience, and Riabni.

What is Rituxan's BLA number?

Rituxan is licensed under BLA 103705, held by Genentech, Inc..

When was Rituxan approved by the FDA?

Rituxan was approved by the FDA on Nov 26, 1997.

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