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 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
33 yr 9 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.