interferon alfa-2a (Roferon-A)
interferon alfa-2a is an FDA-licensed reference biologic from Hoffmann-La Roche Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1986
Reference approved
Reference product
Roferon-A interferon alfa-2a
Hoffmann-La Roche Inc.
- Approved
- Jun 04, 1986
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for interferon alfa-2a from the RCSB Protein Data Bank (PDB 1ITF).
Interactive biological assembly from PDB entry 1ITF. 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 alfa-2a, in chronological order.
Reference approval
Approval date of the reference interferon alfa-2a product.
40 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for interferon alfa-2a (Roferon-A)?
No 351(k) biosimilars or interchangeable biosimilars referencing interferon alfa-2a are listed in the FDA Purple Book yet.
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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.