Purple Book reference family · 351(a) biologic
interferon alfa-n3 (human leukocyte derived) (Alferon N Injection)
interferon alfa-n3 (human leukocyte derived) is an FDA-licensed reference biologic from AIM ImmunoTech Inc..
351(a) biologicBLA 103158 AIM ImmunoTech Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1989
Reference product
Originator biologic
351(a)BLA 103158
Alferon N Injection interferon alfa-n3 (human leukocyte derived)
AIM ImmunoTech Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference interferon alfa-n3 (human leukocyte derived) product.
37 yr 4 mo ago
interferon alfa-n3 (human leukocyte derived): 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 interferon alfa-n3 (human leukocyte derived).
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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.

