asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze)
asparaginase erwinia chrysanthemi (recombinant)-rywn is an FDA-licensed reference biologic from Jazz Pharmaceuticals Ireland Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Rylaze asparaginase erwinia chrysanthemi (recombinant)-rywn
Jazz Pharmaceuticals Ireland Limited
- Approved
- Jun 30, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for asparaginase erwinia chrysanthemi (recombinant)-rywn 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 (recombinant)-rywn, in chronological order.
Reference approval
Approval date of the reference asparaginase erwinia chrysanthemi (recombinant)-rywn product.
5 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze)?
No 351(k) biosimilars or interchangeable biosimilars referencing asparaginase erwinia chrysanthemi (recombinant)-rywn 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.