Purple Book product · Reference 351(a)
Avastin
bevacizumab
At a glance
Feb 26, 2004
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Feb 26, 2004
22 yr 7 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 29, 2027
in 1 yr
Pharmaceutical detail
Strength
400MG/16ML (25MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1048
Product number
002
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.
- 2004AvastinReference 351(a)
bevacizumab · Genentech, Inc.
- 2022VegzelmaBiosimilar 351(k)
bevacizumab-adcd · CELLTRION, Inc.
- 2022VegzelmaBiosimilar 351(k)
bevacizumab-adcd · CELLTRION, Inc.
- 2017MvasiBiosimilar 351(k)
bevacizumab-awwb · Amgen Inc.
- 2017MvasiBiosimilar 351(k)
bevacizumab-awwb · Amgen Inc.
- 2019ZirabevBiosimilar 351(k)
bevacizumab-bvzr · Pfizer Inc.
- 2019ZirabevBiosimilar 351(k)
bevacizumab-bvzr · Pfizer Inc.
- 2022AlymsysBiosimilar 351(k)
bevacizumab-maly · Amneal Pharmaceuticals LLC
- 2022AlymsysBiosimilar 351(k)
bevacizumab-maly · Amneal Pharmaceuticals LLC
- 2025JobevneBiosimilar 351(k)
bevacizumab-nwgd · Biocon Biologics Inc.
- 2025JobevneBiosimilar 351(k)
bevacizumab-nwgd · Biocon Biologics Inc.
- 2023AvziviBiosimilar 351(k)
bevacizumab-tnjn · Bio-Thera Solutions, Ltd.
Patent list (22)
| Patent | Expires | In | Source |
|---|---|---|---|
| 9,795,672 | May 28, 2024 | 2 yr 1 mo ago | FDA |
| 7,485,704 | Mar 08, 2025 | 1 yr 3 mo ago | FDA |
| 10,906,986 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,460,895 | Aug 08, 2029 | in 3 yr 3 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 8 mo | FDA |
| 10,011,856 | May 26, 2031 | in 5 yr 1 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr 3 mo | FDA |
| 10,704,071 | Aug 18, 2031 | in 5 yr 3 mo | FDA |
| 9,487,809 | Jan 14, 2032 | in 5 yr 8 mo | FDA |
| 10,513,697 | Sep 17, 2032 | in 6 yr 5 mo | FDA |
| 10,906,934 | Oct 12, 2033 | in 7 yr 6 mo | FDA |
| 10,017,732 | 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 |
| 9,441,035 | Apr 23, 2034 | in 8 yr | FDA |
| 10,274,466 | Jul 11, 2035 | in 9 yr 3 mo | FDA |
| 10,208,355 | Jul 14, 2035 | in 9 yr 3 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr 3 mo | 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
