FDA.reportPublic FDA data

Kineret Purple Book BLA 103950

BLA number
103950
Proprietary names
Kineret
Proper names
anakinra
Applicant
Swedish Orphan Biovitrum AB (publ)
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
001Kineretanakinra351(a)100MG/0.67MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2001-11-14

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
2021-03-01U001Kineret351(a)RxSwedish Orphan Biovitrum AB (publ)
2020-08-01U001Kineret351(a)RxSwedish Orphan Biovitrum AB (publ)
2020-05-01R001Kineret351(a)RxSwedish Orphan Biovitrum AB (publ)

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Kineret351(a)RxLicensed2001-11-14