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FDA Purple Book · Reference family

Vaccinia Immune Globulin Intravenous (Human) (Cnj-016)

Vaccinia Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from Emergent BioSolutions Canada Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2005

Reference approved

Reference product

351(a)BLA 125109

Cnj-016 Vaccinia Immune Globulin Intravenous (Human)

Emergent BioSolutions Canada Inc.

Approved
May 02, 2005
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Vaccinia Immune Globulin Intravenous (Human), in chronological order.

  1. Reference approval

    Approval date of the reference Vaccinia Immune Globulin Intravenous (Human) product.

    21 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for Vaccinia Immune Globulin Intravenous (Human) (Cnj-016)?

No 351(k) biosimilars or interchangeable biosimilars referencing Vaccinia Immune Globulin Intravenous (Human) are listed in the FDA Purple Book yet.

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