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
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 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.
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