Purple Book reference family · 351(a) biologic
Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro)
Japanese Encephalitis Vaccine, Inactivated, Adsorbed is an FDA-licensed reference biologic from Valneva Austria GmbH.
351(a) biologicBLA 125280 Valneva Austria GmbH
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2009
Reference product
Originator biologic
351(a)BLA 125280
Ixiaro Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Valneva Austria GmbH
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 Japanese Encephalitis Vaccine, Inactivated, Adsorbed product.
17 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
6 yr 5 mo ago
Japanese Encephalitis Vaccine, Inactivated, Adsorbed: 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 Japanese Encephalitis Vaccine, Inactivated, Adsorbed.
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