Alferon N Injection Purple Book BLA 103158

BLA number
103158
Proprietary names
Alferon N Injection
Proper names
interferon alfa-n3 (human leukocyte derived)
Applicant
AIM ImmunoTech Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Alferon N Injectioninterferon alfa-n3 (human leukocyte derived)351(a)5MILLION IU/1MLInjectionIntravenousVialDiscLicensed1989-10-10

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2022-12-01U001Alferon N Injection351(a)DiscAIM ImmunoTech Inc.
2020-05-01R001Alferon N Injection351(a)DiscHemispherx Biopharma, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Alferon N Injection351(a)DiscLicensed1989-10-10