Purple Book product · Reference 351(a)
Actimmune
interferon gamma-1b
Feb 25, 1999
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Feb 25, 1999
27 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 10, 2007
19 yr 9 mo ago
Today
Pharmaceutical detail
Strength
100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
2022
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Actimmune have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Actimmune are listed in the FDA Purple Book yet.
What is Actimmune's BLA number?
Actimmune is licensed under BLA 103836, held by Horizon Therapeutics Ireland DAC.
When was Actimmune approved by the FDA?
Actimmune was approved by the FDA on Feb 25, 1999.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
