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Purple Book reference family · 351(a) biologic

golimumab (Simponi)

golimumab is an FDA-licensed reference biologic from Janssen Biotech, Inc., with 1 approved follow-on biologic.

351(a) biologicBLA 125289 Janssen Biotech, Inc.
Biosimilars
0
Interchangeables
1
Listed patents
26
Reference approved
2013

Reference product

Originator biologic
351(a)BLA 125289

Simponi golimumab

Janssen Biotech, Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for golimumab from the RCSB Protein Data Bank (PDB 5YOY).

3D molecular structure of golimumab (PDB entry 5YOY)

Interactive biological assembly from PDB entry 5YOY. 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 5YOY details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference golimumab product.

    13 yr 7 mo ago

  2. Patent 8,017,325 expires

    Published Purple Book patent expiration.

    in 2 yr 4 mo

  3. Patent 8,017,325 expires

    Published Purple Book patent expiration.

    in 2 yr 4 mo

  4. Patent 10,500,348 expires

    Published Purple Book patent expiration.

    in 5 yr 2 mo

  5. Patent 9,170,249 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  6. Patent 9,170,249 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  7. Patent 9,890,410 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  8. Patent 9,890,410 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  9. Patent 12,139,735 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  10. Patent 12,139,735 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  11. Patent 8,852,889 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  12. Patent 8,852,889 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  13. Patent 9,475,858 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  14. Patent 9,475,858 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  15. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 6 yr 1 mo

  16. Patent 11,633,546 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  17. Patent 8,956,830 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  18. Patent 8,956,830 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  19. Patent 9,217,168 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  20. Patent 9,217,168 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  21. Patent 9,487,810 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  22. Patent 9,487,810 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  23. Patent 9,663,810 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  24. Patent 9,663,810 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  25. Patent 10,421,986 expires

    Published Purple Book patent expiration.

    in 8 yr 11 mo

  26. Patent 10,421,986 expires

    Published Purple Book patent expiration.

    in 8 yr 11 mo

  27. Patent 11,225,516 expires

    Published Purple Book patent expiration.

    in 12 yr 9 mo

  28. Patent 11,225,516 expires

    Published Purple Book patent expiration.

    in 12 yr 9 mo

Biosimilars & interchangeables for golimumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing golimumab.
ProductProper nameApplicantTypeBLAApproved
ImmgolisAlso under this BLA: Immgolis Intrigolimumab-sldiAccord BioPharma Inc.Interchangeable761452

Published patents

Purple Book patent list
Published Purple Book patents for golimumab.
PatentExpiresIn
8,017,325in 2 yr 4 mo
8,017,325in 2 yr 4 mo
10,500,348in 5 yr 2 mo
9,170,249in 5 yr 6 mo
9,170,249in 5 yr 6 mo
9,890,410in 5 yr 6 mo
9,890,410in 5 yr 6 mo
12,139,735in 5 yr 10 mo
12,139,735in 5 yr 10 mo
8,852,889in 5 yr 10 mo
8,852,889in 5 yr 10 mo
9,475,858in 5 yr 10 mo
9,475,858in 5 yr 10 mo
11,633,546in 6 yr 2 mo
8,956,830in 6 yr 6 mo
8,956,830in 6 yr 6 mo
9,217,168in 6 yr 6 mo
9,217,168in 6 yr 6 mo
9,487,810in 6 yr 6 mo
9,487,810in 6 yr 6 mo
9,663,810in 6 yr 6 mo
9,663,810in 6 yr 6 mo
10,421,986in 8 yr 11 mo
10,421,986in 8 yr 11 mo
11,225,516in 12 yr 9 mo
11,225,516in 12 yr 9 mo

golimumab: 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 golimumab.

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