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FDA Purple Book · Reference family

natalizumab (Tysabri)

natalizumab is an FDA-licensed reference biologic from Biogen Inc., with 1 approved follow-on biologic. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

1

Biosimilars

0

Interchangeables

32

Listed patents

2004

Reference approved

Reference product

351(a)BLA 125104

Tysabri natalizumab

Biogen Inc.

Approved
Nov 23, 2004
Marketing
Rx
Center
CDER
Patents
32 listed

Molecular structure

Experimental 3D structure for natalizumab from the RCSB Protein Data Bank (PDB 6FG1).

3D molecular structure of natalizumab (PDB entry 6FG1)

Interactive biological assembly from PDB entry 6FG1. 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 6FG1 details

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference natalizumab product.

    21 yr 10 mo ago

  2. Patent 7,157,276 expires

    Published Purple Book patent expiration.

    2 yr ago

  3. Patent 7,759,117 expires

    Published Purple Book patent expiration.

    2 yr ago

  4. Patent 10,705,095 expires

    Published Purple Book patent expiration.

    2 mo ago

  5. Patent 9,709,575 expires

    Published Purple Book patent expiration.

    2 mo ago

  6. Patent 8,871,449 expires

    Published Purple Book patent expiration.

    2 mo ago

  7. Patent 10,233,245 expires

    Published Purple Book patent expiration.

    in 9 mo

  8. Patent 11,292,845 expires

    Published Purple Book patent expiration.

    in 9 mo

  9. Patent 9,493,567 expires

    Published Purple Book patent expiration.

    in 9 mo

  10. Patent 8,124,350 expires

    Published Purple Book patent expiration.

    in 1 yr 2 mo

  11. Patent 9,696,307 expires

    Published Purple Book patent expiration.

    in 3 yr 9 mo

  12. Patent 9,005,926 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  13. Patent 9,212,379 expires

    Published Purple Book patent expiration.

    in 4 yr 7 mo

  14. Patent 9,096,879 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  15. Patent 10,444,234 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  16. Patent 11,287,423 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  17. Patent 8,318,416 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  18. Patent 10,308,706 expires

    Published Purple Book patent expiration.

    in 4 yr 9 mo

  19. Patent 8,809,049 expires

    Published Purple Book patent expiration.

    in 5 yr 1 mo

  20. Patent 9,109,015 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  21. Patent 9,316,641 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  22. Patent 10,590,454 expires

    Published Purple Book patent expiration.

    in 6 yr

  23. Patent 9,790,533 expires

    Published Purple Book patent expiration.

    in 6 yr

  24. Patent 9,562,252 expires

    Published Purple Book patent expiration.

    in 7 yr 1 mo

  25. Patent 10,119,976 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  26. Patent 10,677,803 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  27. Patent 11,280,794 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  28. Patent 10,676,772 expires

    Published Purple Book patent expiration.

    in 8 yr 4 mo

  29. Patent 9,994,968 expires

    Published Purple Book patent expiration.

    in 8 yr 4 mo

  30. Patent 10,023,831 expires

    Published Purple Book patent expiration.

    in 8 yr 11 mo

  31. Patent 11,124,760 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

  32. Patent 11,268,119 expires

    Published Purple Book patent expiration.

    in 9 yr 10 mo

  33. Patent 10,844,416 expires

    Published Purple Book patent expiration.

    in 10 yr 2 mo

Biosimilars & interchangeables for natalizumab

1 FDA-licensed follow-on biologic referencing natalizumab.

Biosimilars and interchangeable biosimilars referencing natalizumab.
ProductProper nameApplicantTypeBLAApproved
Tyrukonatalizumab-sztnSandoz Inc.Biosimilar 351(k)761322Aug 24, 2023

Published patents

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

Published Purple Book patents for natalizumab.
PatentExpiresIn
7,157,276Jun 21, 20242 yr ago
7,759,117Jun 21, 20242 yr ago
10,705,095Apr 04, 20262 mo ago
9,709,575Apr 04, 20262 mo ago
8,871,449Apr 12, 20262 mo ago
10,233,245Feb 28, 2027in 9 mo
11,292,845Feb 28, 2027in 9 mo
9,493,567Mar 05, 2027in 9 mo
8,124,350Aug 02, 2027in 1 yr 2 mo
9,696,307Feb 05, 2030in 3 yr 9 mo
9,005,926Oct 01, 2030in 4 yr 5 mo
9,212,379Nov 28, 2030in 4 yr 7 mo
9,096,879Jan 07, 2031in 4 yr 8 mo
10,444,234Jan 11, 2031in 4 yr 8 mo
11,287,423Jan 11, 2031in 4 yr 8 mo
8,318,416Jan 20, 2031in 4 yr 8 mo
10,308,706Feb 05, 2031in 4 yr 9 mo
8,809,049May 22, 2031in 5 yr 1 mo
9,109,015Aug 13, 2031in 5 yr 3 mo
9,316,641Jan 09, 2032in 5 yr 8 mo
10,590,454May 11, 2032in 6 yr
9,790,533May 11, 2032in 6 yr
9,562,252May 11, 2033in 7 yr 1 mo
10,119,976May 27, 2034in 8 yr 1 mo
10,677,803May 27, 2034in 8 yr 1 mo
11,280,794May 27, 2034in 8 yr 1 mo
10,676,772Aug 19, 2034in 8 yr 4 mo
9,994,968Aug 19, 2034in 8 yr 4 mo
10,023,831Mar 17, 2035in 8 yr 11 mo
11,124,760Aug 27, 2035in 9 yr 4 mo
11,268,119Feb 21, 2036in 9 yr 10 mo
10,844,416Jun 01, 2036in 10 yr 2 mo

Frequently asked questions

What biosimilars are approved for natalizumab (Tysabri)?

The FDA Purple Book lists 1 approved follow-on biologic referencing natalizumab: Tyruko. Of these, 0 are interchangeable biosimilars and 1 is a 351(k) biosimilar.

Who makes natalizumab biosimilars?

Companies with FDA-approved follow-on biologics referencing natalizumab include Sandoz Inc..

How many patents are listed for natalizumab (Tysabri) in the Purple Book?

32 patents are published in the FDA Purple Book Patent List for natalizumab.

Explore the full FDA Purple Book

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

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