Purple Book product · Reference 351(a)
Perjeta
pertuzumab
At a glance
Jun 08, 2012
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
First licensure
Date the BLA was first licensed.
Jun 08, 2012
14 yr 2 mo ago
Approval
Approval date of this BLA submission.
Jun 08, 2012
14 yr 2 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Jun 08, 2024
2 yr ago
Today
Pharmaceutical detail
Strength
420MG/14ML
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1048
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
Patent list (47)
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,862,817 | Jun 01, 2025 | 1 yr ago | FDA |
| 9,017,671 | Oct 19, 2025 | 8 mo ago | FDA |
| 7,449,184 | Mar 12, 2026 | 3 mo ago | FDA |
| 11,034,754 | May 23, 2026 | 12 d ago | FDA |
| 9,631,007 | May 23, 2026 | 12 d ago | FDA |
| 8,404,234 | Jul 03, 2026 | in 29 d | FDA |
| 8,372,396 | Jul 19, 2026 | in 2 mo | FDA |
| 11,261,238 | May 28, 2028 | in 2 yr | FDA |
| 10,808,037 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,976,127 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,987,637 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,987,638 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,999,791 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 12,098,211 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 12,145,997 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 12,173,080 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,597,776 | Jan 28, 2029 | in 2 yr 8 mo | FDA |
| 12,110,341 | Jan 28, 2029 | in 2 yr 8 mo | FDA |
| 10,689,457 | Jun 15, 2029 | in 3 yr 1 mo | FDA |
| 11,655,305 | Jun 15, 2029 | in 3 yr 1 mo | FDA |
| 9,493,548 | Jun 22, 2029 | in 3 yr 1 mo | FDA |
| 9,181,346 | Jul 18, 2029 | in 3 yr 2 mo | FDA |
| 11,639,395 | Jul 30, 2029 | in 3 yr 2 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 11,225,513 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 12,103,975 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 11,414,498 | Dec 23, 2030 | in 4 yr 7 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 8 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr 3 mo | FDA |
| 8,652,474 | Sep 28, 2031 | in 5 yr 5 mo | FDA |
| 10,087,237 | Jan 21, 2032 | in 5 yr 9 mo | FDA |
| 10,184,106 | Mar 15, 2033 | in 6 yr 11 mo | FDA |
| 9,493,744 | Feb 24, 2034 | in 7 yr 10 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,131,873 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 9,815,904 | Apr 15, 2034 | in 8 yr | FDA |
| 9,969,811 | Apr 15, 2034 | in 8 yr | FDA |
| 12,145,998 | Sep 07, 2034 | in 8 yr 5 mo | FDA |
| 11,638,756 | Feb 28, 2038 | in 11 yr 11 mo | FDA |
| 12,128,103 | Feb 28, 2038 | in 11 yr 11 mo | FDA |
| 11,077,189 | Mar 14, 2039 | in 13 yr | FDA |
| 11,992,529 | Mar 14, 2039 | in 13 yr | FDA |
Taxonomy and ontology
12 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(a)
blaType · 351(a)
application pathway
Section 351(a) Biologic
blaType · 351(a)
product role
Reference or Standalone Biologic
blaType · Reference product
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Intravenous
routeOfAdministration · Intravenous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(a) Biologicmaps to351(a)
- 351(a)classifiesReference or Standalone Biologic
Source provenance
