FDA Purple Book · Reference family
calfactant (Infasurf)
calfactant is an FDA-licensed reference biologic from ONY Biotech Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1998
Reference approved
Reference product
351(a)BLA 020521
Infasurf calfactant
ONY Biotech Inc.
- Approved
- Jul 01, 1998
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for calfactant, in chronological order.
Reference approval
Approval date of the reference calfactant product.
28 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for calfactant (Infasurf)?
No 351(k) biosimilars or interchangeable biosimilars referencing calfactant are listed in the FDA Purple Book yet.
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