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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant
Merck Sharp & Dohme LLC
- Approved
- Dec 10, 2014
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Human Papillomavirus 9-valent Vaccine, Recombinant, in chronological order.
Reference approval
Approval date of the reference Human Papillomavirus 9-valent Vaccine, Recombinant product.
11 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9)?
No 351(k) biosimilars or interchangeable biosimilars referencing Human Papillomavirus 9-valent Vaccine, Recombinant are listed in the FDA Purple Book yet.
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