Purple Book reference family · 351(a) biologic
Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (Gardasil)
Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
351(a) biologicBLA 125126 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2006
Reference product
Originator biologic
351(a)BLA 125126
Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant product.
20 yr 5 mo ago
Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) 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 Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant.
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