Purple Book product · Reference 351(a)
Enbrel
etanercept
At a glance
Feb 01, 2007
Approved
Reference 351(a)
License type
Rx
Marketing
No
Patents listed
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 27, 2006
20 yr 4 mo ago
Approval
Approval date of this BLA submission.
Feb 01, 2007
19 yr 7 mo ago
Today
Pharmaceutical detail
Strength
25MG/0.5ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1132
Product number
004
Submission type
Supplement
Supplement number
5322
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
- 1998EnbrelReference 351(a)
etanercept · Immunex Corporation
- 1999EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2004EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2017Enbrel MiniReference 351(a)
etanercept · Immunex Corporation
- —EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2020EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2016ErelziBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
- 2016ErelziBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
- 2016Erelzi SensoreadyBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
- 2022ErelziBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
- 2019EticovoInterchangeable
etanercept-ykro · Samsung Bioepis Co., Ltd.
- 2019EticovoInterchangeable
etanercept-ykro · Samsung Bioepis Co., Ltd.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
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
Subcutaneous
routeOfAdministration · Subcutaneous
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
