Digoxin Immune Fab (Ovine) (Digibind)
Digoxin Immune Fab (Ovine) is an FDA-licensed reference biologic from Wellcome Foundation Limited Wellcome Research Laboratories. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1986
Reference approved
Reference product
Digibind Digoxin Immune Fab (Ovine)
Wellcome Foundation Limited Wellcome Research Laboratories
- Approved
- Apr 22, 1986
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Digoxin Immune Fab (Ovine), in chronological order.
Reference approval
Approval date of the reference Digoxin Immune Fab (Ovine) product.
40 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
33 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for Digoxin Immune Fab (Ovine) (Digibind)?
No 351(k) biosimilars or interchangeable biosimilars referencing Digoxin Immune Fab (Ovine) are listed in the FDA Purple Book yet.
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