Purple Book reference family · 351(a) biologic
Digoxin Immune Fab (Ovine) (Digibind)
Digoxin Immune Fab (Ovine) is an FDA-licensed reference biologic from Wellcome Foundation Limited Wellcome Research Laboratories.
351(a) biologicBLA 103141 Wellcome Foundation Limited Wellcome Research Laboratories
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1986
Reference product
Originator biologic
351(a)BLA 103141
Digibind Digoxin Immune Fab (Ovine)
Wellcome Foundation Limited Wellcome Research Laboratories
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Digoxin Immune Fab (Ovine) product.
41 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 67 yr 7 mo
Digoxin Immune Fab (Ovine): 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 Digoxin Immune Fab (Ovine).
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
