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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2006
Reference approved
Reference product
Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
Merck Sharp & Dohme LLC
- Approved
- Jun 08, 2006
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant, in chronological order.
Reference approval
Approval date of the reference Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant product.
20 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (Gardasil)?
No 351(k) biosimilars or interchangeable biosimilars referencing Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant are listed in the FDA Purple Book yet.
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