Purple Book reference family · 351(a) biologic
calfactant (Infasurf)
calfactant is an FDA-licensed reference biologic from ONY Biotech Inc..
351(a) biologicBLA 020521 ONY Biotech Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1998
Reference product
Originator biologic
351(a)BLA 020521
Infasurf calfactant
ONY Biotech Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference calfactant product.
28 yr 6 mo ago
calfactant: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for calfactant.
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