Purple Book reference family · 351(a) biologic
Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9)
Human Papillomavirus 9-valent Vaccine, Recombinant is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
351(a) biologicBLA 125508 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2014
Reference product
Originator biologic
351(a)BLA 125508
Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Human Papillomavirus 9-valent Vaccine, Recombinant product.
11 yr 10 mo ago
Human Papillomavirus 9-valent Vaccine, Recombinant: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Human Papillomavirus 9-valent Vaccine, Recombinant.
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