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Purple Book reference family · 351(a) biologic

natalizumab (Tysabri)

natalizumab is an FDA-licensed reference biologic from Biogen Inc., with 1 approved follow-on biologic.

351(a) biologicBLA 125104 Biogen Inc.
Biosimilars
1
Interchangeables
0
Listed patents
32
Reference approved
2004

Reference product

Originator biologic
351(a)BLA 125104

Tysabri natalizumab

Biogen Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
32 listed

Molecular structure

RCSB Protein Data Bank

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, with no need to leave the page.

Open in RCSB viewer PDB 6FG1 details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference natalizumab product.

    22 yr 2 mo ago

  2. Patent 7,157,276 expires

    Published Purple Book patent expiration.

    2 yr 3 mo ago

  3. Patent 7,759,117 expires

    Published Purple Book patent expiration.

    2 yr 3 mo ago

  4. Patent 10,705,095 expires

    Published Purple Book patent expiration.

    5 mo ago

  5. Patent 9,709,575 expires

    Published Purple Book patent expiration.

    5 mo ago

  6. Patent 8,871,449 expires

    Published Purple Book patent expiration.

    5 mo ago

  7. Patent 10,233,245 expires

    Published Purple Book patent expiration.

    in 6 mo

  8. Patent 11,292,845 expires

    Published Purple Book patent expiration.

    in 6 mo

  9. Patent 9,493,567 expires

    Published Purple Book patent expiration.

    in 6 mo

  10. Patent 8,124,350 expires

    Published Purple Book patent expiration.

    in 11 mo

  11. Patent 9,696,307 expires

    Published Purple Book patent expiration.

    in 3 yr 5 mo

  12. Patent 9,005,926 expires

    Published Purple Book patent expiration.

    in 4 yr 1 mo

  13. Patent 9,212,379 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  14. Patent 9,096,879 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  15. Patent 10,444,234 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  16. Patent 11,287,423 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  17. Patent 8,318,416 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  18. Patent 10,308,706 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  19. Patent 8,809,049 expires

    Published Purple Book patent expiration.

    in 4 yr 9 mo

  20. Patent 9,109,015 expires

    Published Purple Book patent expiration.

    in 5 yr

  21. Patent 9,316,641 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  22. Patent 10,590,454 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  23. Patent 9,790,533 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  24. Patent 9,562,252 expires

    Published Purple Book patent expiration.

    in 6 yr 9 mo

  25. Patent 10,119,976 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  26. Patent 10,677,803 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  27. Patent 11,280,794 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  28. Patent 10,676,772 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  29. Patent 9,994,968 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  30. Patent 10,023,831 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  31. Patent 11,124,760 expires

    Published Purple Book patent expiration.

    in 9 yr 1 mo

  32. Patent 11,268,119 expires

    Published Purple Book patent expiration.

    in 9 yr 7 mo

  33. Patent 10,844,416 expires

    Published Purple Book patent expiration.

    in 9 yr 10 mo

Biosimilars & interchangeables for natalizumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing natalizumab.
ProductProper nameApplicantTypeBLAApproved
Tyrukonatalizumab-sztnSandoz Inc.Biosimilar 351(k)761322

Published patents

Purple Book patent list
Published Purple Book patents for natalizumab.
PatentExpiresIn
7,157,2762 yr 3 mo ago
7,759,1172 yr 3 mo ago
10,705,0955 mo ago
9,709,5755 mo ago
8,871,4495 mo ago
10,233,245in 6 mo
11,292,845in 6 mo
9,493,567in 6 mo
8,124,350in 11 mo
9,696,307in 3 yr 5 mo
9,005,926in 4 yr 1 mo
9,212,379in 4 yr 3 mo
9,096,879in 4 yr 5 mo
10,444,234in 4 yr 5 mo
11,287,423in 4 yr 5 mo
8,318,416in 4 yr 5 mo
10,308,706in 4 yr 5 mo
8,809,049in 4 yr 9 mo
9,109,015in 5 yr
9,316,641in 5 yr 5 mo
10,590,454in 5 yr 9 mo
9,790,533in 5 yr 9 mo
9,562,252in 6 yr 9 mo
10,119,976in 7 yr 10 mo
10,677,803in 7 yr 10 mo
11,280,794in 7 yr 10 mo
10,676,772in 8 yr 1 mo
9,994,968in 8 yr 1 mo
10,023,831in 8 yr 8 mo
11,124,760in 9 yr 1 mo
11,268,119in 9 yr 7 mo
10,844,416in 9 yr 10 mo

natalizumab: 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 natalizumab.

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