benzylpenicilloyl polylysine (Pre-Pen)
benzylpenicilloyl polylysine is an FDA-licensed reference biologic from AllerQuest, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1974
Reference approved
Reference product
Pre-Pen benzylpenicilloyl polylysine
AllerQuest, LLC
- Approved
- Jul 25, 1974
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for benzylpenicilloyl polylysine, in chronological order.
Reference approval
Approval date of the reference benzylpenicilloyl polylysine product.
52 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for benzylpenicilloyl polylysine (Pre-Pen)?
No 351(k) biosimilars or interchangeable biosimilars referencing benzylpenicilloyl polylysine are listed in the FDA Purple Book yet.
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