Purple Book reference family · 351(a) biologic
Tick-Borne Encephalitis Vaccine (Ticovac)
Tick-Borne Encephalitis Vaccine is an FDA-licensed reference biologic from Pfizer Ireland Pharmaceuticals Unlimited Company.
351(a) biologicBLA 125740 Pfizer Ireland Pharmaceuticals Unlimited Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2021
Reference product
Originator biologic
351(a)BLA 125740
Ticovac Tick-Borne Encephalitis Vaccine
Pfizer Ireland Pharmaceuticals Unlimited Company
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 Tick-Borne Encephalitis Vaccine product.
5 yr ago
Tick-Borne Encephalitis Vaccine: 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 Tick-Borne Encephalitis Vaccine.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

