Purple Book reference family · 351(a) biologic
benzylpenicilloyl polylysine (Pre-Pen)
benzylpenicilloyl polylysine is an FDA-licensed reference biologic from AllerQuest, LLC.
351(a) biologicBLA 050114 AllerQuest, LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1974
Reference product
Originator biologic
351(a)BLA 050114
Pre-Pen benzylpenicilloyl polylysine
AllerQuest, LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference benzylpenicilloyl polylysine product.
52 yr 9 mo ago
benzylpenicilloyl polylysine: 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 benzylpenicilloyl polylysine.
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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.

