Purple Book product · Reference 351(a)
Simponi
golimumab
At a glance
May 15, 2013
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
May 15, 2013
13 yr 3 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 07, 2032
in 6 yr 5 mo
Pharmaceutical detail
Strength
100MG/ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1864
Product number
003
Submission type
Supplement
Supplement number
77
Change type
U
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
Patent list (26)
| Patent | Expires | In | Source |
|---|---|---|---|
| 8,017,325 | Jan 13, 2029 | in 2 yr 8 mo | FDA |
| 8,017,325 | Jan 13, 2029 | in 2 yr 8 mo | FDA |
| 10,500,348 | Nov 20, 2031 | in 5 yr 7 mo | FDA |
| 9,170,249 | Mar 12, 2032 | in 5 yr 10 mo | FDA |
| 9,170,249 | Mar 12, 2032 | in 5 yr 10 mo | FDA |
| 9,890,410 | Mar 12, 2032 | in 5 yr 10 mo | FDA |
| 9,890,410 | Mar 12, 2032 | in 5 yr 10 mo | FDA |
| 12,139,735 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 12,139,735 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 11,633,546 | Nov 08, 2032 | in 6 yr 6 mo | FDA |
| 8,956,830 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 8,956,830 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,487,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,487,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 10,421,986 | Aug 08, 2035 | in 9 yr 4 mo | FDA |
| 10,421,986 | Aug 08, 2035 | in 9 yr 4 mo | FDA |
| 11,225,516 | May 03, 2039 | in 13 yr 1 mo | FDA |
| 11,225,516 | May 03, 2039 | in 13 yr 1 mo | FDA |
Taxonomy and ontology
13 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
