Purple Book product · Biosimilar 351(k)
Tyenne
tocilizumab-aazg
At a glance
Mar 14, 2025
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Mar 14, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Strength
162MG/0.9ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2146
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of tocilizumab (Actemra)
- 2010ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2013ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2010ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2018ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2010ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2025TyenneBiosimilar 351(k)
tocilizumab-aazg · Fresenius Kabi USA, LLC
Patent list (35)
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,332,289 | Aug 04, 2023 | 2 yr 11 mo ago | FDA |
| 10,744,201 | Apr 28, 2024 | 2 yr 2 mo ago | FDA |
| 7,521,052 | Apr 28, 2024 | 2 yr 2 mo ago | FDA |
| 8,709,409 | Jun 22, 2024 | 2 yr ago | FDA |
| 8,734,800 | Mar 24, 2025 | 1 yr 3 mo ago | FDA |
| 9,902,777 | May 28, 2025 | 1 yr ago | FDA |
| 8,617,550 | Mar 03, 2026 | 3 mo ago | FDA |
| 8,398,980 | Feb 25, 2028 | in 1 yr 9 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 |
| 11,008,394 | Dec 26, 2028 | in 2 yr 7 mo | FDA |
| 11,359,026 | Dec 26, 2028 | in 2 yr 7 mo | FDA |
| 11,584,798 | Dec 26, 2028 | in 2 yr 7 mo | FDA |
| 11,136,375 | Jul 19, 2029 | in 3 yr 2 mo | FDA |
| 8,568,720 | Nov 05, 2029 | in 3 yr 6 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 |
| 10,501,769 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 11,021,728 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 11,136,610 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 11,377,678 | Oct 25, 2030 | in 4 yr 5 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 |
| 11,667,720 | Nov 07, 2031 | in 5 yr 6 mo | FDA |
| 8,580,264 | Nov 07, 2031 | in 5 yr 6 mo | FDA |
| 10,231,981 | Dec 03, 2031 | in 5 yr 7 mo | FDA |
| 10,874,677 | Mar 02, 2032 | in 5 yr 10 mo | FDA |
| 9,539,263 | May 23, 2032 | in 6 yr 1 mo | FDA |
| 9,750,752 | Aug 30, 2032 | in 6 yr 4 mo | FDA |
| 10,590,164 | Mar 19, 2033 | in 6 yr 11 mo | FDA |
| 9,630,988 | Jun 13, 2033 | in 7 yr 2 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 |
| 10,017,732 | Dec 25, 2034 | in 8 yr 8 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr 3 mo | FDA |
Taxonomy and ontology
11 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Biosimilar
blaType · 351(k) Biosimilar
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Biosimilar
blaType · Biosimilar
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(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
