interferon alfa-2b (Intron A)
interferon alfa-2b is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
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Biosimilars
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Interchangeables
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Listed patents
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Reference approved
Reference product
Intron A interferon alfa-2b
Merck Sharp & Dohme LLC
- Approved
- Not listed
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for interferon alfa-2b from the RCSB Protein Data Bank (PDB 1RH2).
Interactive biological assembly from PDB entry 1RH2. 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-2b, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
31 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for interferon alfa-2b (Intron A)?
No 351(k) biosimilars or interchangeable biosimilars referencing interferon alfa-2b 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.