interferon gamma-1b (Actimmune)
interferon gamma-1b is an FDA-licensed reference biologic from Horizon Therapeutics Ireland DAC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1999
Reference approved
Reference product
Actimmune interferon gamma-1b
Horizon Therapeutics Ireland DAC
- Approved
- Feb 25, 1999
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for interferon gamma-1b from the RCSB Protein Data Bank (PDB 5DA1).
Interactive biological assembly from PDB entry 5DA1. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for interferon gamma-1b, in chronological order.
Reference approval
Approval date of the reference interferon gamma-1b product.
27 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
19 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for interferon gamma-1b (Actimmune)?
No 351(k) biosimilars or interchangeable biosimilars referencing interferon gamma-1b are listed in the FDA Purple Book yet.
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