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
Erwinaze asparaginase Erwinia chrysanthemi
Jazz Pharmaceuticals, Inc.
- Approved
- Nov 18, 2011
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for asparaginase Erwinia chrysanthemi from the RCSB Protein Data Bank (PDB 1HG1).
Interactive biological assembly from PDB entry 1HG1. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for asparaginase Erwinia chrysanthemi, in chronological order.
Reference approval
Approval date of the reference asparaginase Erwinia chrysanthemi product.
14 yr 10 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.