FDA.reportPublic FDA data

Perjeta Purple Book BLA 125409

BLA number
125409
Proprietary names
Perjeta
Proper names
pertuzumab
Applicant
Genentech, Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
47 patents listed; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Perjetapertuzumab351(a)420MG/14MLInjectionIntravenousSingle-Dose VialRxLicensed2012-06-08YES

Biosimilar And Interchangeable Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761450Poherdypertuzumab-dpzb351(k) InterchangeableRx2026-06-01

Published Patent List#

Patent, Expiration, Source updated table
PatentExpirationSource updated
11,077,1892039-03-142025-06-11
11,992,5292039-03-142025-06-11
11,638,7562038-02-282025-06-11
12,128,1032038-02-282025-06-11
12,145,9982034-09-072025-06-11
9,815,9042034-04-152025-06-11
9,969,8112034-04-152025-06-11
10,017,7322034-03-142025-06-11
10,131,8732034-03-142025-06-11
10,676,7102034-03-142025-06-11
10,829,7322034-03-142025-06-11
9,493,7442034-02-242025-06-11
10,184,1062033-03-152025-06-11
10,087,2372032-01-212025-06-11
8,652,4742031-09-282025-06-11
10,662,2372031-08-072025-06-11
8,512,9832031-01-042025-06-11
11,414,4982030-12-232025-06-11
10,982,0032030-08-062025-06-11
11,225,5132030-08-062025-06-11
12,103,9752030-08-062025-06-11
9,714,2932030-08-062025-06-11
11,639,3952029-07-302025-06-11
9,181,3462029-07-182025-06-11
9,493,5482029-06-222025-06-11
10,689,4572029-06-152025-06-11
11,655,3052029-06-152025-06-11
11,597,7762029-01-282025-06-11
12,110,3412029-01-282025-06-11
10,808,0372028-07-082025-06-11
11,078,2942028-07-082025-06-11
11,976,1272028-07-082025-06-11
11,987,6372028-07-082025-06-11
11,987,6382028-07-082025-06-11
11,999,7912028-07-082025-06-11
12,098,2112028-07-082025-06-11
12,145,9972028-07-082025-06-11
12,173,0802028-07-082025-06-11
8,574,8692028-07-082025-06-11
11,261,2382028-05-282025-06-11
8,372,3962026-07-192025-06-11
8,404,2342026-07-032025-06-11
11,034,7542026-05-232025-06-11
9,631,0072026-05-232025-06-11
7,449,1842026-03-122025-06-11
9,017,6712025-10-192025-06-11
7,862,8172025-06-012025-06-11

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2025-06-01U001Perjeta351(a)RxGenentech, Inc.
2020-08-01U001Perjeta351(a)RxGenentech, Inc.
2020-05-01R001Perjeta351(a)RxGenentech, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Perjeta351(a)RxLicensed2012-06-08