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FDA Purple Book · Reference family

Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro)

Japanese Encephalitis Vaccine, Inactivated, Adsorbed is an FDA-licensed reference biologic from Valneva Austria GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2009

Reference approved

Reference product

351(a)BLA 125280

Ixiaro Japanese Encephalitis Vaccine, Inactivated, Adsorbed

Valneva Austria GmbH

Approved
Mar 30, 2009
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Japanese Encephalitis Vaccine, Inactivated, Adsorbed, in chronological order.

  1. Reference approval

    Approval date of the reference Japanese Encephalitis Vaccine, Inactivated, Adsorbed product.

    17 yr 5 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    6 yr 2 mo ago

Frequently asked questions

Are there biosimilars approved for Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro)?

No 351(k) biosimilars or interchangeable biosimilars referencing Japanese Encephalitis Vaccine, Inactivated, Adsorbed are listed in the FDA Purple Book yet.

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