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Purple Book reference family · 351(a) biologic

rituximab (Rituxan)

rituximab is an FDA-licensed reference biologic from IDEC Pharmaceuticals Corp., with 3 approved follow-on biologics.

351(a) biologicBLA 103737 IDEC Pharmaceuticals Corp.
Biosimilars
3
Interchangeables
0
Listed patents
15
Reference approved
2002

Reference product

Originator biologic
351(a)BLA 103737

Rituxan rituximab

IDEC Pharmaceuticals Corp.

View full reference-product record
Approved
Marketing
Disc
Center
CDER
Patents
15 listed

Molecular structure

RCSB Protein Data Bank

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, with no need to leave the page.

Open in RCSB viewer PDB 4KAQ details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference rituximab product.

    24 yr 11 mo ago

  2. Patent 7,485,704 expires

    Published Purple Book patent expiration.

    1 yr 7 mo ago

  3. Patent 7,976,838 expires

    Published Purple Book patent expiration.

    1 yr 3 mo ago

  4. Patent 10,450,379 expires

    Published Purple Book patent expiration.

    in 2 mo

  5. Patent 10,654,940 expires

    Published Purple Book patent expiration.

    in 2 mo

  6. Patent 10,759,866 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  7. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  8. Patent 8,460,895 expires

    Published Purple Book patent expiration.

    in 2 yr 11 mo

  9. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  10. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  11. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 4 mo

  12. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

  13. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  14. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  15. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  16. Patent 10,336,983 expires

    Published Purple Book patent expiration.

    in 9 yr

Biosimilars & interchangeables for rituximab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing rituximab.
ProductProper nameApplicantTypeBLAApproved
Truximarituximab-abbsCELLTRION, Inc.Biosimilar 351(k)761088
Ruxiencerituximab-pvvrPfizer Ireland Pharmaceuticals Unlimited CompanyBiosimilar 351(k)761103
Riabnirituximab-arrxAmgen Inc.Biosimilar 351(k)761140

Published patents

Purple Book patent list
Published Purple Book patents for rituximab.
PatentExpiresIn
7,485,7041 yr 7 mo ago
7,976,8381 yr 3 mo ago
10,450,379in 2 mo
10,654,940in 2 mo
10,759,866in 1 yr 10 mo
8,574,869in 1 yr 10 mo
8,460,895in 2 yr 11 mo
10,982,003in 3 yr 11 mo
9,714,293in 3 yr 11 mo
8,512,983in 4 yr 4 mo
10,662,237in 4 yr 11 mo
10,017,732in 7 yr 7 mo
10,676,710in 7 yr 7 mo
10,829,732in 7 yr 7 mo
10,336,983in 9 yr

rituximab: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for rituximab.

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