Purple Book reference family · 351(a) biologic
Crotalidae Polyvalent Immune Fab (Ovine) (Crofab)
Crotalidae Polyvalent Immune Fab (Ovine) is an FDA-licensed reference biologic from BTG International Inc..
351(a) biologicBLA 103788 BTG International Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 103788
Crofab Crotalidae Polyvalent Immune Fab (Ovine)
BTG International Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Crotalidae Polyvalent Immune Fab (Ovine) product.
26 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
19 yr 3 mo ago
Crotalidae Polyvalent 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 Crotalidae Polyvalent Immune Fab (Ovine).
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
