FDA.reportPublic FDA data

Humira Purple Book BLA 125057

BLA number
125057
Proprietary names
Humira
Proper names
adalimumab
Applicant
AbbVie Inc.
Center
CDER
First observed release
2020-02-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
66 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
001Humiraadalimumab351(a)40MG/0.8MLInjectionSubcutaneousAutoinjectorRxLicensed2002-12-31YES
002Humiraadalimumab351(a)40MG/0.8MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2002-12-31YES
003Humiraadalimumab351(a)20MG/0.4MLInjectionSubcutaneousPre-Filled SyringeDisc*Licensed2008-02-21YES
004Humiraadalimumab351(a)40MG/0.8MLInjectionSubcutaneousSingle-Dose VialDisc*Licensed2013-04-24YES
005Humiraadalimumab351(a)10MG/0.2MLInjectionSubcutaneousPre-Filled SyringeDisc*Licensed2014-09-23YES
006Humiraadalimumab351(a)40MG/0.4MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2015-11-23YES
007Humiraadalimumab351(a)40MG/0.4MLInjectionSubcutaneousAutoinjectorRxLicensed2016-03-09YES
008Humiraadalimumab351(a)80MG/0.8MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2016-10-17YES
009Humiraadalimumab351(a)80MG/0.8MLInjectionSubcutaneousAutoinjectorRxLicensed2017-04-21YES
010Humiraadalimumab351(a)20MG/0.2MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2017-04-28YES
011Humiraadalimumab351(a)10MG/0.1MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2017-04-28YES

Biosimilar And Interchangeable Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761024Amjevitaadalimumab-atto351(k) InterchangeableRx2026-06-01
761058Cyltezoadalimumab-adbm351(k) InterchangeableRx2026-06-01
761059Hadlimaadalimumab-bwwd351(k) InterchangeableRx2026-06-01
761071Hyrimozadalimumab-adaz351(k) InterchangeableRx2026-06-01
761118Abriladaadalimumab-afzb351(k) InterchangeableRx2026-06-01
761154Hulioadalimumab-fkjp351(k) InterchangeableRx2026-06-01
761216Yusimryadalimumab-aqvh351(k) BiosimilarRx2026-06-01
761219Yuflymaadalimumab-aaty351(k) InterchangeableRx2026-06-01
761255Idacioadalimumab-aacf351(k) BiosimilarRx2026-06-01
761299Simlandiadalimumab-ryvk351(k) InterchangeableRx2026-06-01

Published Patent List#

Patent, Expiration, Source updated table
PatentExpirationSource updated
9,550,8262034-11-142025-06-11
9,499,6142034-03-142025-06-11
9,150,6452033-05-132025-06-11
9,266,9492033-05-132025-06-11
9,315,5742033-04-212025-06-11
9,085,6182033-03-142025-06-11
9,181,3372033-03-142025-06-11
9,181,5722033-03-142025-06-11
9,290,5682033-03-142025-06-11
9,334,3192033-03-142025-06-11
9,346,8792033-03-142025-06-11
9,359,4342033-03-142025-06-11
9,499,6162033-03-142025-06-11
9,708,4002033-03-142025-06-11
9,062,1062032-04-262025-06-11
9,090,6882032-04-262025-06-11
9,505,8342032-04-262025-06-11
9,522,9532032-04-262025-06-11
9,683,0332032-04-262025-06-11
9,957,3182032-04-262025-06-11
8,708,9682032-01-242025-06-11
9,339,6102032-01-242025-06-11
9,624,2952031-03-312025-06-11
8,999,3372031-02-062025-06-11
8,420,0812030-01-132025-06-11
11,167,0302028-11-282025-06-11
11,191,8342028-11-282025-06-11
9,085,6192028-11-282025-06-11
9,284,3702028-06-102025-06-11
9,669,0932028-06-102025-06-11
8,889,1362027-10-092025-06-11
8,663,9452027-09-132025-06-11
8,906,6462027-09-132025-06-11
8,911,9642027-09-132025-06-11
9,090,8672027-09-132025-06-11
9,234,0322027-09-132025-06-11
9,284,3712027-09-132025-06-11
8,715,6642027-07-242025-06-11
8,926,9752027-06-082025-06-11
11,083,7922027-04-042025-06-11
8,231,8762027-04-042025-06-11
8,883,1562027-04-042025-06-11
8,895,0092027-04-042025-06-11
8,906,3722027-04-042025-06-11
8,916,1532027-04-042025-06-11
9,096,6662027-04-042025-06-11
9,102,7232027-04-042025-06-11
9,273,1322027-04-042025-06-11
9,328,1652027-04-042025-06-11
9,913,9022027-04-042025-06-11
8,808,7002026-05-162025-06-11
8,961,9732025-04-112025-06-11
8,961,9742025-04-112025-06-11
8,986,6932025-04-112025-06-11
9,061,0052025-04-112025-06-11
9,187,5592025-04-112025-06-11
9,512,2162025-04-112025-06-11
8,906,3732023-07-182025-06-11
9,067,9922023-07-182025-06-11
9,085,6202023-07-182025-06-11
9,090,6892023-07-182025-06-11
6,805,6862023-05-062025-06-11
8,911,7372022-06-052025-06-11
8,974,7902022-06-052025-06-11
8,992,9262022-06-052025-06-11
9,546,2122022-06-052025-06-11

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2026-04-01U004Humira351(a)Disc*AbbVie Inc.
2025-05-01U004Humira351(a)DiscAbbVie Inc.
2024-11-01U003Humira351(a)Disc*AbbVie Inc.
2024-11-01U005Humira351(a)Disc*AbbVie Inc.
2022-06-01U003Humira351(a)DiscAbbVie Inc.
2022-06-01U005Humira351(a)DiscAbbVie Inc.
2021-06-01U001Humira351(a)RxAbbVie Inc.
2021-06-01U002Humira351(a)RxAbbVie Inc.
2021-06-01U003Humira351(a)RxAbbVie Inc.
2021-06-01U004Humira351(a)RxAbbVie Inc.
2021-06-01U005Humira351(a)RxAbbVie Inc.
2021-06-01U006Humira351(a)RxAbbVie Inc.
2021-06-01U007Humira351(a)RxAbbVie Inc.
2021-06-01U008Humira351(a)RxAbbVie Inc.
2021-06-01U009Humira351(a)RxAbbVie Inc.
2021-06-01U010Humira351(a)RxAbbVie Inc.
2021-06-01U011Humira351(a)RxAbbVie Inc.
2021-05-01U001Humira351(a)RxAbbVie Inc.
2021-05-01U002Humira351(a)RxAbbVie Inc.
2021-05-01U003Humira351(a)RxAbbVie Inc.
2021-05-01U004Humira351(a)RxAbbVie Inc.
2021-05-01U005Humira351(a)RxAbbVie Inc.
2021-05-01U006Humira351(a)RxAbbVie Inc.
2021-05-01U007Humira351(a)RxAbbVie Inc.
2021-05-01U008Humira351(a)RxAbbVie Inc.
2021-05-01U009Humira351(a)RxAbbVie Inc.
2021-05-01U010Humira351(a)RxAbbVie Inc.
2021-05-01U011Humira351(a)RxAbbVie Inc.
2020-08-01U001Humira351(a)RxAbbVie Inc.
2020-08-01U002Humira351(a)RxAbbVie Inc.
2020-08-01U003Humira351(a)RxAbbVie Inc.
2020-08-01U004Humira351(a)RxAbbVie Inc.
2020-08-01U005Humira351(a)RxAbbVie Inc.
2020-08-01U006Humira351(a)RxAbbVie Inc.
2020-08-01U007Humira351(a)RxAbbVie Inc.
2020-08-01U008Humira351(a)RxAbbVie Inc.
2020-08-01U009Humira351(a)RxAbbVie Inc.
2020-08-01U010Humira351(a)RxAbbVie Inc.
2020-08-01U011Humira351(a)RxAbbVie Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2026-04-01004Humira351(a)Disc*Licensed2013-04-24
2025-05-01004Humira351(a)DiscLicensed2013-04-24
2024-11-01003Humira351(a)Disc*Licensed2008-02-21
2024-11-01005Humira351(a)Disc*Licensed2014-09-23
2022-06-01003Humira351(a)DiscLicensed2008-02-21
2022-06-01005Humira351(a)DiscLicensed2014-09-23
2021-06-01001Humira351(a)RxLicensed2002-12-31
2021-06-01002Humira351(a)RxLicensed2002-12-31
2021-06-01003Humira351(a)RxLicensed2008-02-21
2021-06-01004Humira351(a)RxLicensed2013-04-24
2021-06-01005Humira351(a)RxLicensed2014-09-23
2021-06-01007Humira351(a)RxLicensed2016-03-09
2021-06-01008Humira351(a)RxLicensed2016-10-17
2021-06-01009Humira351(a)RxLicensed2017-04-21
2021-06-01011Humira351(a)RxLicensed2017-04-28
2020-05-01001Humira351(a)RxLicensed2017-04-21
2020-05-01002Humira351(a)RxLicensed2016-10-17
2020-05-01003Humira351(a)RxLicensed2002-12-31
2020-05-01004Humira351(a)RxLicensed2016-03-09
2020-05-01005Humira351(a)RxLicensed2002-12-31
2020-05-01006Humira351(a)RxLicensed2015-11-23
2020-05-01007Humira351(a)RxLicensed2008-02-21
2020-05-01008Humira351(a)RxLicensed2017-04-28
2020-05-01009Humira351(a)RxLicensed2014-09-23
2020-05-01010Humira351(a)RxLicensed2017-04-28
2020-05-01011Humira351(a)RxLicensed2013-04-24
2020-02-01001Humira351(a)MarketedLicensed2017-04-21
2020-02-01002Humira351(a)MarketedLicensed2016-10-17
2020-02-01003Humira351(a)MarketedLicensed2002-12-31
2020-02-01004Humira351(a)MarketedLicensed2016-03-09
2020-02-01005Humira351(a)MarketedLicensed2002-12-31
2020-02-01006Humira351(a)MarketedLicensed2015-11-23
2020-02-01007Humira351(a)MarketedLicensed2008-02-21
2020-02-01008Humira351(a)MarketedLicensed2017-04-28
2020-02-01009Humira351(a)MarketedLicensed2014-09-23
2020-02-01010Humira351(a)MarketedLicensed2017-04-28
2020-02-01011Humira351(a)MarketedLicensed2013-04-24