Purple Book reference family · 351(a) biologic
Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection (Anascorp)
Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection is an FDA-licensed reference biologic from Rare Disease Therapeutics, Inc. (RDT).
351(a) biologicBLA 125335 Rare Disease Therapeutics, Inc. (RDT)
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011
Reference product
Originator biologic
351(a)BLA 125335
Anascorp Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
Rare Disease Therapeutics, Inc. (RDT)
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 Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection product.
15 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 3 mo ago
Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection: 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 Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection.
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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.
