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FDA Purple Book · Reference family

pertuzumab (Perjeta)

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

0

Biosimilars

1

Interchangeables

47

Listed patents

2012

Reference approved

Reference product

351(a)BLA 125409

Perjeta pertuzumab

Genentech, Inc.

Approved
Jun 08, 2012
Marketing
Rx
Center
CDER
Patents
47 listed

Molecular structure

Experimental 3D structure for pertuzumab from the RCSB Protein Data Bank (PDB 4LLW).

3D molecular structure of pertuzumab (PDB entry 4LLW)

Interactive biological assembly from PDB entry 4LLW. 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 4LLW details

Exclusivity & patent cliffs

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

  1. First licensure

    Date pertuzumab was first licensed by the FDA.

    14 yr 2 mo ago

  2. Reference approval

    Approval date of the reference pertuzumab product.

    14 yr 2 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    2 yr ago

  4. Patent 7,862,817 expires

    Published Purple Book patent expiration.

    1 yr ago

  5. Patent 9,017,671 expires

    Published Purple Book patent expiration.

    8 mo ago

  6. Patent 7,449,184 expires

    Published Purple Book patent expiration.

    3 mo ago

  7. Patent 11,034,754 expires

    Published Purple Book patent expiration.

    9 d ago

  8. Patent 9,631,007 expires

    Published Purple Book patent expiration.

    9 d ago

  9. Patent 8,404,234 expires

    Published Purple Book patent expiration.

    in 1 mo

  10. Patent 8,372,396 expires

    Published Purple Book patent expiration.

    in 2 mo

  11. Patent 11,261,238 expires

    Published Purple Book patent expiration.

    in 2 yr

  12. Patent 10,808,037 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  13. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  14. Patent 11,976,127 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  15. Patent 11,987,637 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  16. Patent 11,987,638 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  17. Patent 11,999,791 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  18. Patent 12,098,211 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  19. Patent 12,145,997 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  20. Patent 12,173,080 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  21. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  22. Patent 11,597,776 expires

    Published Purple Book patent expiration.

    in 2 yr 8 mo

  23. Patent 12,110,341 expires

    Published Purple Book patent expiration.

    in 2 yr 8 mo

  24. Patent 10,689,457 expires

    Published Purple Book patent expiration.

    in 3 yr 1 mo

  25. Patent 11,655,305 expires

    Published Purple Book patent expiration.

    in 3 yr 1 mo

  26. Patent 9,493,548 expires

    Published Purple Book patent expiration.

    in 3 yr 1 mo

  27. Patent 9,181,346 expires

    Published Purple Book patent expiration.

    in 3 yr 2 mo

  28. Patent 11,639,395 expires

    Published Purple Book patent expiration.

    in 3 yr 3 mo

  29. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  30. Patent 11,225,513 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  31. Patent 12,103,975 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  32. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  33. Patent 11,414,498 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  34. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  35. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  36. Patent 8,652,474 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  37. Patent 10,087,237 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  38. Patent 10,184,106 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  39. Patent 9,493,744 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  40. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  41. Patent 10,131,873 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  42. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  43. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  44. Patent 9,815,904 expires

    Published Purple Book patent expiration.

    in 8 yr

  45. Patent 9,969,811 expires

    Published Purple Book patent expiration.

    in 8 yr

  46. Patent 12,145,998 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  47. Patent 11,638,756 expires

    Published Purple Book patent expiration.

    in 11 yr 11 mo

  48. Patent 12,128,103 expires

    Published Purple Book patent expiration.

    in 11 yr 11 mo

  49. Patent 11,077,189 expires

    Published Purple Book patent expiration.

    in 13 yr

  50. Patent 11,992,529 expires

    Published Purple Book patent expiration.

    in 13 yr

Biosimilars & interchangeables for pertuzumab

1 FDA-licensed follow-on biologic referencing pertuzumab.

Biosimilars and interchangeable biosimilars referencing pertuzumab.
ProductProper nameApplicantTypeBLAApproved
Poherdypertuzumab-dpzbShanghai Henlius Biotech, Inc.Interchangeable761450Nov 13, 2025

Published patents

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

Published Purple Book patents for pertuzumab.
PatentExpiresIn
7,862,817Jun 01, 20251 yr ago
9,017,671Oct 19, 20258 mo ago
7,449,184Mar 12, 20263 mo ago
11,034,754May 23, 20269 d ago
9,631,007May 23, 20269 d ago
8,404,234Jul 03, 2026in 1 mo
8,372,396Jul 19, 2026in 2 mo
11,261,238May 28, 2028in 2 yr
10,808,037Jul 08, 2028in 2 yr 2 mo
11,078,294Jul 08, 2028in 2 yr 2 mo
11,976,127Jul 08, 2028in 2 yr 2 mo
11,987,637Jul 08, 2028in 2 yr 2 mo
11,987,638Jul 08, 2028in 2 yr 2 mo
11,999,791Jul 08, 2028in 2 yr 2 mo
12,098,211Jul 08, 2028in 2 yr 2 mo
12,145,997Jul 08, 2028in 2 yr 2 mo
12,173,080Jul 08, 2028in 2 yr 2 mo
8,574,869Jul 08, 2028in 2 yr 2 mo
11,597,776Jan 28, 2029in 2 yr 8 mo
12,110,341Jan 28, 2029in 2 yr 8 mo
10,689,457Jun 15, 2029in 3 yr 1 mo
11,655,305Jun 15, 2029in 3 yr 1 mo
9,493,548Jun 22, 2029in 3 yr 1 mo
9,181,346Jul 18, 2029in 3 yr 2 mo
11,639,395Jul 30, 2029in 3 yr 3 mo
10,982,003Aug 06, 2030in 4 yr 3 mo
11,225,513Aug 06, 2030in 4 yr 3 mo
12,103,975Aug 06, 2030in 4 yr 3 mo
9,714,293Aug 06, 2030in 4 yr 3 mo
11,414,498Dec 23, 2030in 4 yr 8 mo
8,512,983Jan 04, 2031in 4 yr 8 mo
10,662,237Aug 07, 2031in 5 yr 3 mo
8,652,474Sep 28, 2031in 5 yr 5 mo
10,087,237Jan 21, 2032in 5 yr 9 mo
10,184,106Mar 15, 2033in 6 yr 11 mo
9,493,744Feb 24, 2034in 7 yr 10 mo
10,017,732Mar 14, 2034in 7 yr 11 mo
10,131,873Mar 14, 2034in 7 yr 11 mo
10,676,710Mar 14, 2034in 7 yr 11 mo
10,829,732Mar 14, 2034in 7 yr 11 mo
9,815,904Apr 15, 2034in 8 yr
9,969,811Apr 15, 2034in 8 yr
12,145,998Sep 07, 2034in 8 yr 5 mo
11,638,756Feb 28, 2038in 11 yr 11 mo
12,128,103Feb 28, 2038in 11 yr 11 mo
11,077,189Mar 14, 2039in 13 yr
11,992,529Mar 14, 2039in 13 yr

Frequently asked questions

What biosimilars are approved for pertuzumab (Perjeta)?

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

When does pertuzumab (Perjeta) lose reference-product exclusivity?

pertuzumab's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending June 8, 2024.

Is there an interchangeable biosimilar for pertuzumab?

Yes. Poherdy is approved as interchangeable biosimilar for pertuzumab, meaning it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

Who makes pertuzumab biosimilars?

Companies with FDA-approved follow-on biologics referencing pertuzumab include Shanghai Henlius Biotech, Inc..

How many patents are listed for pertuzumab (Perjeta) in the Purple Book?

47 patents are published in the FDA Purple Book Patent List for pertuzumab.

Explore the full FDA Purple Book

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

Open the Purple Book tool