FDA Purple Book · Reference family
asparaginase (Elspar)
asparaginase is an FDA-licensed reference biologic from Recordati Rare Diseases, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1978
Reference approved
Reference product
351(a)BLA 101063
Elspar asparaginase
Recordati Rare Diseases, Inc.
- Approved
- Jan 10, 1978
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for asparaginase, in chronological order.
Reference approval
Approval date of the reference asparaginase product.
49 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for asparaginase (Elspar)?
No 351(k) biosimilars or interchangeable biosimilars referencing asparaginase are listed in the FDA Purple Book yet.
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