Purple Book product · Biosimilar 351(k)

Truxima

rituximab-abbs

351(k) BiosimilarBLA 761088RxLicensed CELLTRION, Inc.

View rituximab family Label PDF Open on FDA Purple Book

Nov 28, 2018

Approved

Biosimilar 351(k)

License type

Marketing

Listed patents

Truxima (rituximab-abbs) is a Biosimilar 351(k) referencing rituximab, licensed under a 351(k) BLA in 2018 and marketed by CELLTRION, Inc.. The Purple Book lists 15 published patents for this product.

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

Key dates

Approval
Approval date of this BLA submission.
Nov 28, 2018
7 yr 9 mo ago
Today

Pharmaceutical detail

Strength

500MG/50ML (10MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1996

Product number

002

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of rituximab (Rituxan)

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
monthly-downloadMonthly download · Jul 02, 2026

Change history

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

Frequently asked questions

When do Truxima's patents expire?

The FDA Purple Book lists 15 published patents for Truxima, 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.

Is Truxima a biosimilar?

Yes. Truxima is a Biosimilar 351(k) referencing rituximab, licensed under a 351(k) BLA.

Is Truxima interchangeable?

Truxima is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.

What is Truxima's BLA number?

Truxima is licensed under BLA 761088, held by CELLTRION, Inc..

When was Truxima approved by the FDA?

Truxima was approved by the FDA on Nov 28, 2018.

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