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FDA Purple Book · Reference family

golimumab (Simponi)

golimumab is an FDA-licensed reference biologic from Janssen Biotech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

26

Listed patents

2013

Reference approved

Reference product

351(a)BLA 125289

Simponi golimumab

Janssen Biotech, Inc.

Approved
May 15, 2013
Marketing
Rx
Center
CDER
Patents
26 listed

Molecular structure

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 — no need to leave the page.

Open in RCSB viewer PDB 5YOY details

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference golimumab product.

    13 yr 3 mo ago

  2. Patent 8,017,325 expires

    Published Purple Book patent expiration.

    in 2 yr 8 mo

  3. Patent 8,017,325 expires

    Published Purple Book patent expiration.

    in 2 yr 8 mo

  4. Patent 10,500,348 expires

    Published Purple Book patent expiration.

    in 5 yr 7 mo

  5. Patent 9,170,249 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  6. Patent 9,170,249 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  7. Patent 9,890,410 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  8. Patent 9,890,410 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  9. Patent 12,139,735 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  10. Patent 12,139,735 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  11. Patent 8,852,889 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  12. Patent 8,852,889 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  13. Patent 9,475,858 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  14. Patent 9,475,858 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  15. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 6 yr 5 mo

  16. Patent 11,633,546 expires

    Published Purple Book patent expiration.

    in 6 yr 6 mo

  17. Patent 8,956,830 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  18. Patent 8,956,830 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  19. Patent 9,217,168 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  20. Patent 9,217,168 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  21. Patent 9,487,810 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  22. Patent 9,487,810 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  23. Patent 9,663,810 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  24. Patent 9,663,810 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  25. Patent 10,421,986 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

  26. Patent 10,421,986 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

  27. Patent 11,225,516 expires

    Published Purple Book patent expiration.

    in 13 yr 1 mo

  28. Patent 11,225,516 expires

    Published Purple Book patent expiration.

    in 13 yr 1 mo

Published patents

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

Published Purple Book patents for golimumab.
PatentExpiresIn
8,017,325Jan 13, 2029in 2 yr 8 mo
8,017,325Jan 13, 2029in 2 yr 8 mo
10,500,348Nov 20, 2031in 5 yr 7 mo
9,170,249Mar 12, 2032in 5 yr 10 mo
9,170,249Mar 12, 2032in 5 yr 10 mo
9,890,410Mar 12, 2032in 5 yr 10 mo
9,890,410Mar 12, 2032in 5 yr 10 mo
12,139,735Jul 06, 2032in 6 yr 2 mo
12,139,735Jul 06, 2032in 6 yr 2 mo
8,852,889Jul 06, 2032in 6 yr 2 mo
8,852,889Jul 06, 2032in 6 yr 2 mo
9,475,858Jul 06, 2032in 6 yr 2 mo
9,475,858Jul 06, 2032in 6 yr 2 mo
11,633,546Nov 08, 2032in 6 yr 6 mo
8,956,830Mar 14, 2033in 6 yr 11 mo
8,956,830Mar 14, 2033in 6 yr 11 mo
9,217,168Mar 14, 2033in 6 yr 11 mo
9,217,168Mar 14, 2033in 6 yr 11 mo
9,487,810Mar 14, 2033in 6 yr 11 mo
9,487,810Mar 14, 2033in 6 yr 11 mo
9,663,810Mar 14, 2033in 6 yr 11 mo
9,663,810Mar 14, 2033in 6 yr 11 mo
10,421,986Aug 08, 2035in 9 yr 4 mo
10,421,986Aug 08, 2035in 9 yr 4 mo
11,225,516May 03, 2039in 13 yr 1 mo
11,225,516May 03, 2039in 13 yr 1 mo

Frequently asked questions

Are there biosimilars approved for golimumab (Simponi)?

No 351(k) biosimilars or interchangeable biosimilars referencing golimumab are listed in the FDA Purple Book yet.

How many patents are listed for golimumab (Simponi) in the Purple Book?

26 patents are published in the FDA Purple Book Patent List for golimumab.

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

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