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Purple Book reference family · 351(a) biologic

pertuzumab (Perjeta)

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

351(a) biologicBLA 125409 Genentech, Inc.
Biosimilars
0
Interchangeables
1
Listed patents
47
Reference approved
2012

Reference product

Originator biologic
351(a)BLA 125409

Perjeta pertuzumab

Genentech, Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for pertuzumab from the RCSB Protein Data Bank (PDB 1S78).

3D molecular structure of pertuzumab (PDB entry 1S78)

Interactive biological assembly from PDB entry 1S78. 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 1S78 details

Exclusivity & patent cliffs

Protection horizon

  1. First licensure

    Date pertuzumab was first licensed by the FDA.

    14 yr 6 mo ago

  2. Reference approval

    Approval date of the reference pertuzumab product.

    14 yr 6 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    2 yr 4 mo ago

  4. Patent 7,862,817 expires

    Published Purple Book patent expiration.

    1 yr 4 mo ago

  5. Patent 9,017,671 expires

    Published Purple Book patent expiration.

    11 mo ago

  6. Patent 7,449,184 expires

    Published Purple Book patent expiration.

    6 mo ago

  7. Patent 11,034,754 expires

    Published Purple Book patent expiration.

    4 mo ago

  8. Patent 9,631,007 expires

    Published Purple Book patent expiration.

    4 mo ago

  9. Patent 8,404,234 expires

    Published Purple Book patent expiration.

    3 mo ago

  10. Patent 8,372,396 expires

    Published Purple Book patent expiration.

    2 mo ago

  11. Patent 11,261,238 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  12. Patent 10,808,037 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  13. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  14. Patent 11,976,127 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  15. Patent 11,987,637 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  16. Patent 11,987,638 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  17. Patent 11,999,791 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  18. Patent 12,098,211 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  19. Patent 12,145,997 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  20. Patent 12,173,080 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  21. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  22. Patent 11,597,776 expires

    Published Purple Book patent expiration.

    in 2 yr 5 mo

  23. Patent 12,110,341 expires

    Published Purple Book patent expiration.

    in 2 yr 5 mo

  24. Patent 10,689,457 expires

    Published Purple Book patent expiration.

    in 2 yr 9 mo

  25. Patent 11,655,305 expires

    Published Purple Book patent expiration.

    in 2 yr 9 mo

  26. Patent 9,493,548 expires

    Published Purple Book patent expiration.

    in 2 yr 10 mo

  27. Patent 9,181,346 expires

    Published Purple Book patent expiration.

    in 2 yr 10 mo

  28. Patent 11,639,395 expires

    Published Purple Book patent expiration.

    in 2 yr 11 mo

  29. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  30. Patent 11,225,513 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  31. Patent 12,103,975 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  32. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  33. Patent 11,414,498 expires

    Published Purple Book patent expiration.

    in 4 yr 4 mo

  34. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 4 mo

  35. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

  36. Patent 8,652,474 expires

    Published Purple Book patent expiration.

    in 5 yr 1 mo

  37. Patent 10,087,237 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  38. Patent 10,184,106 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  39. Patent 9,493,744 expires

    Published Purple Book patent expiration.

    in 7 yr 6 mo

  40. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  41. Patent 10,131,873 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  42. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  43. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  44. Patent 9,815,904 expires

    Published Purple Book patent expiration.

    in 7 yr 8 mo

  45. Patent 9,969,811 expires

    Published Purple Book patent expiration.

    in 7 yr 8 mo

  46. Patent 12,145,998 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  47. Patent 11,638,756 expires

    Published Purple Book patent expiration.

    in 11 yr 7 mo

  48. Patent 12,128,103 expires

    Published Purple Book patent expiration.

    in 11 yr 7 mo

  49. Patent 11,077,189 expires

    Published Purple Book patent expiration.

    in 12 yr 8 mo

  50. Patent 11,992,529 expires

    Published Purple Book patent expiration.

    in 12 yr 8 mo

Biosimilars & interchangeables for pertuzumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing pertuzumab.
ProductProper nameApplicantTypeBLAApproved
Poherdypertuzumab-dpzbShanghai Henlius Biotech, Inc.Interchangeable761450

Published patents

Purple Book patent list
Published Purple Book patents for pertuzumab.
PatentExpiresIn
7,862,8171 yr 4 mo ago
9,017,67111 mo ago
7,449,1846 mo ago
11,034,7544 mo ago
9,631,0074 mo ago
8,404,2343 mo ago
8,372,3962 mo ago
11,261,238in 1 yr 9 mo
10,808,037in 1 yr 10 mo
11,078,294in 1 yr 10 mo
11,976,127in 1 yr 10 mo
11,987,637in 1 yr 10 mo
11,987,638in 1 yr 10 mo
11,999,791in 1 yr 10 mo
12,098,211in 1 yr 10 mo
12,145,997in 1 yr 10 mo
12,173,080in 1 yr 10 mo
8,574,869in 1 yr 10 mo
11,597,776in 2 yr 5 mo
12,110,341in 2 yr 5 mo
10,689,457in 2 yr 9 mo
11,655,305in 2 yr 9 mo
9,493,548in 2 yr 10 mo
9,181,346in 2 yr 10 mo
11,639,395in 2 yr 11 mo
10,982,003in 3 yr 11 mo
11,225,513in 3 yr 11 mo
12,103,975in 3 yr 11 mo
9,714,293in 3 yr 11 mo
11,414,498in 4 yr 4 mo
8,512,983in 4 yr 4 mo
10,662,237in 4 yr 11 mo
8,652,474in 5 yr 1 mo
10,087,237in 5 yr 5 mo
10,184,106in 6 yr 7 mo
9,493,744in 7 yr 6 mo
10,017,732in 7 yr 7 mo
10,131,873in 7 yr 7 mo
10,676,710in 7 yr 7 mo
10,829,732in 7 yr 7 mo
9,815,904in 7 yr 8 mo
9,969,811in 7 yr 8 mo
12,145,998in 8 yr 1 mo
11,638,756in 11 yr 7 mo
12,128,103in 11 yr 7 mo
11,077,189in 12 yr 8 mo
11,992,529in 12 yr 8 mo

pertuzumab: 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 pertuzumab.

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