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FDA Purple Book · Reference family

asparaginase Erwinia chrysanthemi (Erwinaze)

asparaginase Erwinia chrysanthemi is an FDA-licensed reference biologic from Jazz Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2011

Reference approved

Reference product

351(a)BLA 125359

Erwinaze asparaginase Erwinia chrysanthemi

Jazz Pharmaceuticals, Inc.

Approved
Nov 18, 2011
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for asparaginase Erwinia chrysanthemi, in chronological order.

  1. Reference approval

    Approval date of the reference asparaginase Erwinia chrysanthemi product.

    14 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for asparaginase Erwinia chrysanthemi (Erwinaze)?

No 351(k) biosimilars or interchangeable biosimilars referencing asparaginase Erwinia chrysanthemi are listed in the FDA Purple Book yet.

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