FDA.reportPublic FDA data

Tysabri Purple Book BLA 125104

BLA number
125104
Proprietary names
Tysabri
Proper names
natalizumab
Applicant
Biogen Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
32 patents listed; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Tysabrinatalizumab351(a)300MG/15ML (20MG/ML)InjectionIntravenousSingle-Dose VialRxLicensed2004-11-23YES

Biosimilar And Interchangeable Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761322Tyrukonatalizumab-sztn351(k) BiosimilarRx2026-06-01

Published Patent List#

Patent, Expiration, Source updated table
PatentExpirationSource updated
10,844,4162036-06-012025-06-11
11,268,1192036-02-212025-06-11
11,124,7602035-08-272025-06-11
10,023,8312035-03-172025-06-11
10,676,7722034-08-192025-06-11
9,994,9682034-08-192025-06-11
10,119,9762034-05-272025-06-11
10,677,8032034-05-272025-06-11
11,280,7942034-05-272025-06-11
9,562,2522033-05-112025-06-11
10,590,4542032-05-112025-06-11
9,790,5332032-05-112025-06-11
9,316,6412032-01-092025-06-11
9,109,0152031-08-132025-06-11
8,809,0492031-05-222025-06-11
10,308,7062031-02-052025-06-11
8,318,4162031-01-202025-06-11
10,444,2342031-01-112025-06-11
11,287,4232031-01-112025-06-11
9,096,8792031-01-072025-06-11
9,212,3792030-11-282025-06-11
9,005,9262030-10-012025-06-11
9,696,3072030-02-052025-06-11
8,124,3502027-08-022025-06-11
9,493,5672027-03-052025-06-11
10,233,2452027-02-282025-06-11
11,292,8452027-02-282025-06-11
8,871,4492026-04-122025-06-11
10,705,0952026-04-042025-06-11
9,709,5752026-04-042025-06-11
7,157,2762024-06-212025-06-11
7,759,1172024-06-212025-06-11

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2022-10-01U001Tysabri351(a)RxBiogen Inc.
2020-05-01R001Tysabri351(a)RxBiogen Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Tysabri351(a)RxLicensed2004-11-23