Crotalidae Polyvalent Immune Fab (Ovine) (Crofab)
Crotalidae Polyvalent Immune Fab (Ovine) is an FDA-licensed reference biologic from BTG International Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2000
Reference approved
Reference product
Crofab Crotalidae Polyvalent Immune Fab (Ovine)
BTG International Inc.
- Approved
- Oct 02, 2000
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Crotalidae Polyvalent Immune Fab (Ovine), in chronological order.
Reference approval
Approval date of the reference Crotalidae Polyvalent Immune Fab (Ovine) product.
26 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
18 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for Crotalidae Polyvalent Immune Fab (Ovine) (Crofab)?
No 351(k) biosimilars or interchangeable biosimilars referencing Crotalidae Polyvalent Immune Fab (Ovine) are listed in the FDA Purple Book yet.
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