Purple Book product · Biosimilar 351(k)
Tyruko
natalizumab-sztn
At a glance
Aug 24, 2023
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Aug 24, 2023
2 yr 10 mo ago
Today
Pharmaceutical detail
Strength
300MG/15ML (20MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2003
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of natalizumab (Tysabri)
Patent list (32)
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,157,276 | Jun 21, 2024 | 2 yr ago | FDA |
| 7,759,117 | Jun 21, 2024 | 2 yr ago | FDA |
| 10,705,095 | Apr 04, 2026 | 2 mo ago | FDA |
| 9,709,575 | Apr 04, 2026 | 2 mo ago | FDA |
| 8,871,449 | Apr 12, 2026 | 2 mo ago | FDA |
| 10,233,245 | Feb 28, 2027 | in 9 mo | FDA |
| 11,292,845 | Feb 28, 2027 | in 9 mo | FDA |
| 9,493,567 | Mar 05, 2027 | in 9 mo | FDA |
| 8,124,350 | Aug 02, 2027 | in 1 yr 2 mo | FDA |
| 9,696,307 | Feb 05, 2030 | in 3 yr 9 mo | FDA |
| 9,005,926 | Oct 01, 2030 | in 4 yr 5 mo | FDA |
| 9,212,379 | Nov 28, 2030 | in 4 yr 7 mo | FDA |
| 9,096,879 | Jan 07, 2031 | in 4 yr 8 mo | FDA |
| 10,444,234 | Jan 11, 2031 | in 4 yr 8 mo | FDA |
| 11,287,423 | Jan 11, 2031 | in 4 yr 8 mo | FDA |
| 8,318,416 | Jan 20, 2031 | in 4 yr 8 mo | FDA |
| 10,308,706 | Feb 05, 2031 | in 4 yr 9 mo | FDA |
| 8,809,049 | May 22, 2031 | in 5 yr | FDA |
| 9,109,015 | Aug 13, 2031 | in 5 yr 3 mo | FDA |
| 9,316,641 | Jan 09, 2032 | in 5 yr 8 mo | FDA |
| 10,590,454 | May 11, 2032 | in 6 yr | FDA |
| 9,790,533 | May 11, 2032 | in 6 yr | FDA |
| 9,562,252 | May 11, 2033 | in 7 yr | FDA |
| 10,119,976 | May 27, 2034 | in 8 yr 1 mo | FDA |
| 10,677,803 | May 27, 2034 | in 8 yr 1 mo | FDA |
| 11,280,794 | May 27, 2034 | in 8 yr 1 mo | FDA |
| 10,676,772 | Aug 19, 2034 | in 8 yr 4 mo | FDA |
| 9,994,968 | Aug 19, 2034 | in 8 yr 4 mo | FDA |
| 10,023,831 | Mar 17, 2035 | in 8 yr 11 mo | FDA |
| 11,124,760 | Aug 27, 2035 | in 9 yr 4 mo | FDA |
| 11,268,119 | Feb 21, 2036 | in 9 yr 10 mo | FDA |
| 10,844,416 | Jun 01, 2036 | in 10 yr 2 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
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(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
