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FDA Purple Book · Reference family

rituximab (Rituxan)

rituximab is an FDA-licensed reference biologic from IDEC Pharmaceuticals Corp., with 3 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

3

Biosimilars

0

Interchangeables

15

Listed patents

2002

Reference approved

Reference product

351(a)BLA 103737

Rituxan rituximab

IDEC Pharmaceuticals Corp.

Approved
Feb 19, 2002
Marketing
Disc
Center
CDER
Patents
15 listed

Molecular structure

Experimental 3D structure for rituximab from the RCSB Protein Data Bank (PDB 4KAQ).

3D molecular structure of rituximab (PDB entry 4KAQ)

Interactive biological assembly from PDB entry 4KAQ. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.

Open in RCSB viewer PDB 4KAQ details

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for rituximab, in chronological order.

  1. Reference approval

    Approval date of the reference rituximab product.

    24 yr 8 mo ago

  2. Patent 7,485,704 expires

    Published Purple Book patent expiration.

    1 yr 3 mo ago

  3. Patent 7,976,838 expires

    Published Purple Book patent expiration.

    11 mo ago

  4. Patent 10,450,379 expires

    Published Purple Book patent expiration.

    in 6 mo

  5. Patent 10,654,940 expires

    Published Purple Book patent expiration.

    in 6 mo

  6. Patent 10,759,866 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  7. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  8. Patent 8,460,895 expires

    Published Purple Book patent expiration.

    in 3 yr 3 mo

  9. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  10. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  11. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  12. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  13. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  14. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  15. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  16. Patent 10,336,983 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

Biosimilars & interchangeables for rituximab

3 FDA-licensed follow-on biologics referencing rituximab.

Biosimilars and interchangeable biosimilars referencing rituximab.
ProductProper nameApplicantTypeBLAApproved
Truximarituximab-abbsCELLTRION, Inc.Biosimilar 351(k)761088Nov 28, 2018
Ruxiencerituximab-pvvrPfizer Ireland Pharmaceuticals Unlimited CompanyBiosimilar 351(k)761103Jul 23, 2019
Riabnirituximab-arrxAmgen Inc.Biosimilar 351(k)761140Dec 17, 2020

Published patents

Patents the BLA holder has published in the FDA Purple Book Patent List for rituximab.

Published Purple Book patents for rituximab.
PatentExpiresIn
7,485,704Mar 08, 20251 yr 3 mo ago
7,976,838Jun 30, 202511 mo ago
10,450,379Nov 14, 2026in 6 mo
10,654,940Nov 14, 2026in 6 mo
10,759,866Jul 08, 2028in 2 yr 2 mo
8,574,869Jul 08, 2028in 2 yr 2 mo
8,460,895Aug 08, 2029in 3 yr 3 mo
10,982,003Aug 06, 2030in 4 yr 3 mo
9,714,293Aug 06, 2030in 4 yr 3 mo
8,512,983Jan 04, 2031in 4 yr 8 mo
10,662,237Aug 07, 2031in 5 yr 3 mo
10,017,732Mar 14, 2034in 7 yr 11 mo
10,676,710Mar 14, 2034in 7 yr 11 mo
10,829,732Mar 14, 2034in 7 yr 11 mo
10,336,983Jul 31, 2035in 9 yr 4 mo

Frequently asked questions

What biosimilars are approved for rituximab (Rituxan)?

The FDA Purple Book lists 3 approved follow-on biologics referencing rituximab: Truxima, Ruxience, and Riabni. Of these, 0 are interchangeable biosimilars and 3 are 351(k) biosimilars.

Who makes rituximab biosimilars?

Companies with FDA-approved follow-on biologics referencing rituximab include CELLTRION, Inc., Pfizer Ireland Pharmaceuticals Unlimited Company, and Amgen Inc..

How many patents are listed for rituximab (Rituxan) in the Purple Book?

15 patents are published in the FDA Purple Book Patent List for rituximab.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

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