FDA.reportPublic FDA data

Aranesp Purple Book BLA 103951

BLA number
103951
Proprietary names
Aranesp
Proper names
darbepoetin alpha
Applicant
Amgen Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; 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
001Aranespdarbepoetin alpha351(a)25MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2001-09-17
002Aranespdarbepoetin alpha351(a)40MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2001-09-17
003Aranespdarbepoetin alpha351(a)60MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2001-09-17
004Aranespdarbepoetin alpha351(a)100MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2001-09-17
005Aranespdarbepoetin alpha351(a)200MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2001-09-17
006Aranespdarbepoetin alpha351(a)25MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2001-09-17
007Aranespdarbepoetin alpha351(a)40MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2001-09-17
008Aranespdarbepoetin alpha351(a)60MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2001-09-17
009Aranespdarbepoetin alpha351(a)100MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2001-09-17
010Aranespdarbepoetin alpha351(a)200MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2001-09-17
011Aranespdarbepoetin alpha351(a)150MCG/0.75MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2002-07-19
012Aranespdarbepoetin alpha351(a)300MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2002-07-19
013Aranespdarbepoetin alpha351(a)500MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2002-07-19
014Aranespdarbepoetin alpha351(a)60MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2002-12-17
015Aranespdarbepoetin alpha351(a)100MCG/0.5MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2002-12-17
016Aranespdarbepoetin alpha351(a)150MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2002-12-17
017Aranespdarbepoetin alpha351(a)200MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2002-12-17
018Aranespdarbepoetin alpha351(a)300MCG/0.6MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2002-12-17
019Aranespdarbepoetin alpha351(a)500MCG/1MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2002-12-17
020Aranespdarbepoetin alpha351(a)25MCG/0.42MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2003-12-12
021Aranespdarbepoetin alpha351(a)25MCG/0.42MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
022Aranespdarbepoetin alpha351(a)40MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeDiscLicensed2003-12-12
023Aranespdarbepoetin alpha351(a)40MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
024Aranespdarbepoetin alpha351(a)60MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
025Aranespdarbepoetin alpha351(a)100MCG/0.5MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
026Aranespdarbepoetin alpha351(a)150MCG/0.3MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
027Aranespdarbepoetin alpha351(a)200MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
028Aranespdarbepoetin alpha351(a)300MCG/0.6MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
029Aranespdarbepoetin alpha351(a)500MCG/1MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed2003-12-12
030Aranespdarbepoetin alpha351(a)150MCG/0.75MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2003-12-12
031Aranespdarbepoetin alpha351(a)300MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2003-12-12
032Aranespdarbepoetin alpha351(a)500MCG/1MLInjectionIntravenous, SubcutaneousSingle-Dose VialDiscLicensed2003-12-12
033Aranespdarbepoetin alpha351(a)25MCG/0.42MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
034Aranespdarbepoetin alpha351(a)40MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
035Aranespdarbepoetin alpha351(a)60MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
036Aranespdarbepoetin alpha351(a)100MCG/0.5MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
037Aranespdarbepoetin alpha351(a)150MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
038Aranespdarbepoetin alpha351(a)200MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
039Aranespdarbepoetin alpha351(a)300MCG/0.6MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
040Aranespdarbepoetin alpha351(a)500MCG/1MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
041Aranespdarbepoetin alpha351(a)25MCG/0.42MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
042Aranespdarbepoetin alpha351(a)40MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
043Aranespdarbepoetin alpha351(a)60MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
044Aranespdarbepoetin alpha351(a)100MCG/0.5MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
045Aranespdarbepoetin alpha351(a)150MCG/0.3MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
046Aranespdarbepoetin alpha351(a)200MCG/0.4MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
047Aranespdarbepoetin alpha351(a)300MCG/0.6MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
048Aranespdarbepoetin alpha351(a)500MCG/1MLInjectionIntravenous, SubcutaneousAutoinjectorDiscLicensed2006-06-29
049Aranespdarbepoetin alpha351(a)10MCG/0.4MLInjectionIntravenous, SubcutaneousPre-Filled SyringeRxLicensed

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2024-05-01U031Aranesp351(a)DiscAmgen Inc.
2023-07-01U030Aranesp351(a)DiscAmgen Inc.
2023-07-01U032Aranesp351(a)DiscAmgen Inc.
2021-01-01U014Aranesp351(a)DiscAmgen, Inc.
2021-01-01U015Aranesp351(a)DiscAmgen, Inc.
2021-01-01U016Aranesp351(a)DiscAmgen, Inc.
2021-01-01U017Aranesp351(a)DiscAmgen, Inc.
2021-01-01U018Aranesp351(a)DiscAmgen, Inc.
2021-01-01U019Aranesp351(a)DiscAmgen, Inc.
2020-10-01U001Aranesp351(a)RxAmgen, Inc.
2020-10-01U002Aranesp351(a)RxAmgen, Inc.
2020-10-01U003Aranesp351(a)RxAmgen, Inc.
2020-10-01U004Aranesp351(a)RxAmgen, Inc.
2020-10-01U005Aranesp351(a)RxAmgen, Inc.
2020-10-01U006Aranesp351(a)DiscAmgen, Inc.
2020-10-01U007Aranesp351(a)DiscAmgen, Inc.
2020-10-01U008Aranesp351(a)DiscAmgen, Inc.
2020-10-01U009Aranesp351(a)DiscAmgen, Inc.
2020-10-01U010Aranesp351(a)DiscAmgen, Inc.
2020-10-01U011Aranesp351(a)DiscAmgen, Inc.
2020-10-01U012Aranesp351(a)DiscAmgen, Inc.
2020-10-01U013Aranesp351(a)DiscAmgen, Inc.
2020-10-01U014Aranesp351(a)DiscAmgen, Inc.
2020-10-01U015Aranesp351(a)DiscAmgen, Inc.
2020-10-01U016Aranesp351(a)DiscAmgen, Inc.
2020-10-01U017Aranesp351(a)DiscAmgen, Inc.
2020-10-01U018Aranesp351(a)DiscAmgen, Inc.
2020-10-01U019Aranesp351(a)DiscAmgen, Inc.
2020-10-01U020Aranesp351(a)DiscAmgen, Inc.
2020-10-01U021Aranesp351(a)RxAmgen, Inc.
2020-10-01U022Aranesp351(a)DiscAmgen, Inc.
2020-10-01U023Aranesp351(a)RxAmgen, Inc.
2020-10-01U024Aranesp351(a)RxAmgen, Inc.
2020-10-01U025Aranesp351(a)RxAmgen, Inc.
2020-10-01U026Aranesp351(a)RxAmgen, Inc.
2020-10-01U027Aranesp351(a)RxAmgen, Inc.
2020-10-01U028Aranesp351(a)RxAmgen, Inc.
2020-10-01U029Aranesp351(a)RxAmgen, Inc.
2020-10-01U030Aranesp351(a)RxAmgen, Inc.
2020-10-01U031Aranesp351(a)RxAmgen, Inc.
2020-10-01U032Aranesp351(a)RxAmgen, Inc.
2020-10-01U033Aranesp351(a)DiscAmgen, Inc.
2020-10-01U034Aranesp351(a)DiscAmgen, Inc.
2020-10-01U035Aranesp351(a)DiscAmgen, Inc.
2020-10-01U036Aranesp351(a)DiscAmgen, Inc.
2020-10-01U037Aranesp351(a)DiscAmgen, Inc.
2020-10-01U038Aranesp351(a)DiscAmgen, Inc.
2020-10-01U039Aranesp351(a)DiscAmgen, Inc.
2020-10-01U040Aranesp351(a)DiscAmgen, Inc.
2020-10-01U041Aranesp351(a)DiscAmgen, Inc.
2020-10-01U042Aranesp351(a)DiscAmgen, Inc.
2020-10-01U043Aranesp351(a)DiscAmgen, Inc.
2020-10-01U044Aranesp351(a)DiscAmgen, Inc.
2020-10-01U045Aranesp351(a)DiscAmgen, Inc.
2020-10-01U046Aranesp351(a)DiscAmgen, Inc.
2020-10-01U047Aranesp351(a)DiscAmgen, Inc.
2020-10-01U048Aranesp351(a)DiscAmgen, Inc.
2020-10-01U049Aranesp351(a)RxAmgen, Inc.
2020-05-01R001Aranesp351(a)RxAmgen Inc.
2020-05-01R002Aranesp351(a)RxAmgen Inc.
2020-05-01R003Aranesp351(a)RxAmgen Inc.
2020-05-01R004Aranesp351(a)RxAmgen Inc.
2020-05-01R005Aranesp351(a)RxAmgen Inc.
2020-05-01R006Aranesp351(a)DiscAmgen Inc.
2020-05-01R007Aranesp351(a)DiscAmgen Inc.
2020-05-01R008Aranesp351(a)DiscAmgen Inc.
2020-05-01R009Aranesp351(a)DiscAmgen Inc.
2020-05-01R010Aranesp351(a)DiscAmgen Inc.
2020-05-01R011Aranesp351(a)DiscAmgen Inc.
2020-05-01R012Aranesp351(a)DiscAmgen Inc.
2020-05-01R013Aranesp351(a)DiscAmgen Inc.
2020-05-01R014Aranesp351(a)DiscAmgen Inc.
2020-05-01R015Aranesp351(a)DiscAmgen Inc.
2020-05-01R016Aranesp351(a)DiscAmgen Inc.
2020-05-01R017Aranesp351(a)DiscAmgen Inc.
2020-05-01R018Aranesp351(a)DiscAmgen Inc.
2020-05-01R019Aranesp351(a)DiscAmgen Inc.
2020-05-01R020Aranesp351(a)DiscAmgen Inc.
2020-05-01R021Aranesp351(a)RxAmgen Inc.
2020-05-01R022Aranesp351(a)DiscAmgen Inc.
2020-05-01R023Aranesp351(a)RxAmgen Inc.
2020-05-01R024Aranesp351(a)RxAmgen Inc.
2020-05-01R025Aranesp351(a)RxAmgen Inc.
2020-05-01R026Aranesp351(a)RxAmgen Inc.
2020-05-01R027Aranesp351(a)RxAmgen Inc.
2020-05-01R028Aranesp351(a)RxAmgen Inc.
2020-05-01R029Aranesp351(a)RxAmgen Inc.
2020-05-01R030Aranesp351(a)RxAmgen Inc.
2020-05-01R031Aranesp351(a)RxAmgen Inc.
2020-05-01R032Aranesp351(a)RxAmgen Inc.
2020-05-01R033Aranesp351(a)DiscAmgen Inc.
2020-05-01R034Aranesp351(a)DiscAmgen Inc.
2020-05-01R035Aranesp351(a)DiscAmgen Inc.
2020-05-01R036Aranesp351(a)DiscAmgen Inc.
2020-05-01R037Aranesp351(a)DiscAmgen Inc.
2020-05-01R038Aranesp351(a)DiscAmgen Inc.
2020-05-01R039Aranesp351(a)DiscAmgen Inc.
2020-05-01R040Aranesp351(a)DiscAmgen Inc.
2020-05-01R041Aranesp351(a)DiscAmgen Inc.
2020-05-01R042Aranesp351(a)DiscAmgen Inc.
2020-05-01R043Aranesp351(a)DiscAmgen Inc.
2020-05-01R044Aranesp351(a)DiscAmgen Inc.
2020-05-01R045Aranesp351(a)DiscAmgen Inc.
2020-05-01R046Aranesp351(a)DiscAmgen Inc.
2020-05-01R047Aranesp351(a)DiscAmgen Inc.
2020-05-01R048Aranesp351(a)DiscAmgen Inc.
2020-05-01R049Aranesp351(a)RxAmgen Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2024-05-01031Aranesp351(a)DiscLicensed2003-12-12
2023-07-01030Aranesp351(a)DiscLicensed2003-12-12
2023-07-01032Aranesp351(a)DiscLicensed2003-12-12
2021-01-01014Aranesp351(a)DiscLicensed2002-12-17
2021-01-01015Aranesp351(a)DiscLicensed2002-12-17
2021-01-01016Aranesp351(a)DiscLicensed2002-12-17
2021-01-01017Aranesp351(a)DiscLicensed2002-12-17
2021-01-01018Aranesp351(a)DiscLicensed2002-12-17
2021-01-01019Aranesp351(a)DiscLicensed2002-12-17
2020-05-01001Aranesp351(a)RxLicensed2001-09-17
2020-05-01002Aranesp351(a)RxLicensed2001-09-17
2020-05-01003Aranesp351(a)RxLicensed2001-09-17
2020-05-01004Aranesp351(a)RxLicensed2001-09-17
2020-05-01005Aranesp351(a)RxLicensed2001-09-17
2020-05-01006Aranesp351(a)DiscLicensed2001-09-17
2020-05-01007Aranesp351(a)DiscLicensed2001-09-17
2020-05-01008Aranesp351(a)DiscLicensed2001-09-17
2020-05-01009Aranesp351(a)DiscLicensed2001-09-17
2020-05-01010Aranesp351(a)DiscLicensed2001-09-17
2020-05-01011Aranesp351(a)DiscLicensed2002-07-19
2020-05-01012Aranesp351(a)DiscLicensed2002-07-19
2020-05-01013Aranesp351(a)DiscLicensed2002-07-19
2020-05-01014Aranesp351(a)DiscLicensed2003-12-12
2020-05-01015Aranesp351(a)DiscLicensed2003-12-12
2020-05-01016Aranesp351(a)DiscLicensed2003-12-12
2020-05-01017Aranesp351(a)DiscLicensed2003-12-12
2020-05-01018Aranesp351(a)DiscLicensed2003-12-12
2020-05-01019Aranesp351(a)DiscLicensed2003-12-12
2020-05-01020Aranesp351(a)DiscLicensed2003-12-12
2020-05-01021Aranesp351(a)RxLicensed2003-12-12
2020-05-01022Aranesp351(a)DiscLicensed2003-12-12
2020-05-01023Aranesp351(a)RxLicensed2003-12-12
2020-05-01024Aranesp351(a)RxLicensed2003-12-12
2020-05-01025Aranesp351(a)RxLicensed2003-12-12
2020-05-01026Aranesp351(a)RxLicensed2003-12-12
2020-05-01027Aranesp351(a)RxLicensed2003-12-12
2020-05-01028Aranesp351(a)RxLicensed2003-12-12
2020-05-01029Aranesp351(a)RxLicensed2003-12-12
2020-05-01030Aranesp351(a)RxLicensed2003-12-12
2020-05-01031Aranesp351(a)RxLicensed2003-12-12
2020-05-01032Aranesp351(a)RxLicensed2003-12-12
2020-05-01033Aranesp351(a)DiscLicensed2006-06-29
2020-05-01034Aranesp351(a)DiscLicensed2006-06-29
2020-05-01035Aranesp351(a)DiscLicensed2006-06-29
2020-05-01036Aranesp351(a)DiscLicensed2006-06-29
2020-05-01037Aranesp351(a)DiscLicensed2006-06-29
2020-05-01038Aranesp351(a)DiscLicensed2006-06-29
2020-05-01039Aranesp351(a)DiscLicensed2006-06-29
2020-05-01040Aranesp351(a)DiscLicensed2006-06-29
2020-05-01041Aranesp351(a)DiscLicensed2006-06-29
2020-05-01042Aranesp351(a)DiscLicensed2006-06-29
2020-05-01043Aranesp351(a)DiscLicensed2006-06-29
2020-05-01044Aranesp351(a)DiscLicensed2006-06-29
2020-05-01045Aranesp351(a)DiscLicensed2006-06-29
2020-05-01046Aranesp351(a)DiscLicensed2006-06-29
2020-05-01047Aranesp351(a)DiscLicensed2006-06-29
2020-05-01048Aranesp351(a)DiscLicensed2006-06-29
2020-05-01049Aranesp351(a)RxLicensed