FDA.reportPublic FDA data

Gardasil 9 Purple Book BLA 125508

BLA number
125508
Proprietary names
Gardasil 9
Proper names
Human Papillomavirus 9-valent Vaccine, Recombinant
Applicant
Merck Sharp & Dohme LLC
Center
CBER
First observed release
2020-08-01
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
001Gardasil 9Human Papillomavirus 9-valent Vaccine, Recombinant351(a)0.5MLInjectionIntramuscularPre-Filled SyringeRxLicensed2014-12-10
002Gardasil 9Human Papillomavirus 9-valent Vaccine, Recombinant351(a)0.5MLInjectionIntramuscularSingle-dose vialRxLicensed2014-12-10

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
2023-03-01U001Gardasil 9351(a)RxMerck Sharp & Dohme LLC
2023-03-01U002Gardasil 9351(a)RxMerck Sharp & Dohme LLC
2021-05-01U001Gardasil 9351(a)RxMerck Sharp & Dohme Corp.
2021-05-01U002Gardasil 9351(a)RxMerck Sharp & Dohme Corp.
2020-08-01R001Gardasil 9351(a)RxMerck Sharp & Dohme Corp.
2020-08-01R002Gardasil 9351(a)RxMerck Sharp & Dohme Corp.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-08-01001Gardasil 9351(a)RxLicensed2014-12-10
2020-08-01002Gardasil 9351(a)RxLicensed2014-12-10