Purple Book product · Reference 351(a)
Tysabri
natalizumab
At a glance
Nov 23, 2004
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Nov 23, 2004
21 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
1697
Product number
001
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.
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(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
