FDA.reportPublic FDA data

Actemra Purple Book BLA 125276

BLA number
125276
Proprietary names
Actemra
Proper names
tocilizumab
Applicant
Genentech, Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
35 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
001Actemratocilizumab351(a)80MG/4ML (20MG/ML)InjectionIntravenousSingle-Dose VialRxLicensed2010-01-08YES
002Actemratocilizumab351(a)200MG/10ML (20MG/ML)InjectionIntravenousSingle-Dose VialRxLicensed2010-01-08YES
003Actemratocilizumab351(a)400MG/20ML (20MG/ML)InjectionIntravenousSingle-Dose VialRxLicensed2010-01-08YES

Published Patent List#

Patent, Expiration, Source updated table
PatentExpirationSource updated
10,336,9832035-07-312025-06-11
10,017,7322034-12-252025-06-11
10,676,7102034-03-142025-06-11
10,829,7322034-03-142025-06-11
9,630,9882033-06-132025-06-11
10,590,1642033-03-192025-06-11
9,750,7522032-08-302025-06-11
9,539,2632032-05-232025-06-11
10,874,6772032-03-022025-06-11
10,231,9812031-12-032025-06-11
11,667,7202031-11-072025-06-11
8,580,2642031-11-072025-06-11
10,662,2372031-08-072025-06-11
8,512,9832031-01-042025-06-11
10,501,7692030-10-252025-06-11
11,021,7282030-10-252025-06-11
11,136,6102030-10-252025-06-11
11,377,6782030-10-252025-06-11
10,982,0032030-08-062025-06-11
9,714,2932030-08-062025-06-11
8,568,7202029-11-052025-06-11
11,136,3752029-07-192025-06-11
11,008,3942028-12-262025-06-11
11,359,0262028-12-262025-06-11
11,584,7982028-12-262025-06-11
11,078,2942028-07-082025-06-11
8,574,8692028-07-082025-06-11
8,398,9802028-02-252025-06-11
8,617,5502026-03-032025-06-11
9,902,7772025-05-282025-06-11
8,734,8002025-03-242025-06-11
8,709,4092024-06-222025-06-11
10,744,2012024-04-282025-06-11
7,521,0522024-04-282025-06-11
7,332,2892023-08-042025-06-11

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2024-11-01U001Actemra351(a)RxGenentech, Inc.
2024-11-01U002Actemra351(a)RxGenentech, Inc.
2024-11-01U003Actemra351(a)RxGenentech, Inc.
2024-03-01U001Actemra351(a)RxGenentech, Inc.
2024-03-01U002Actemra351(a)RxGenentech, Inc.
2024-03-01U003Actemra351(a)RxGenentech, Inc.
2023-03-01U001Actemra351(a)RxGenentech, Inc.
2023-03-01U002Actemra351(a)RxGenentech, Inc.
2023-03-01U003Actemra351(a)RxGenentech, Inc.
2020-08-01U001Actemra351(a)RxGenentech, Inc.
2020-08-01U002Actemra351(a)RxGenentech, Inc.
2020-08-01U003Actemra351(a)RxGenentech, Inc.
2020-05-01R001Actemra351(a)RxGenentech, Inc.
2020-05-01R002Actemra351(a)RxGenentech, Inc.
2020-05-01R003Actemra351(a)RxGenentech, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Actemra351(a)RxLicensed2010-01-08
2020-05-01002Actemra351(a)RxLicensed2010-01-08
2020-05-01003Actemra351(a)RxLicensed2010-01-08