FDA Purple Book · Reference family
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.
0
Biosimilars
0
Interchangeables
0
Listed patents
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Reference approved
Reference product
351(a)BLA 103132
Intron A interferon alfa-2b
Merck Sharp & Dohme LLC
- Approved
- Not listed
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
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 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.
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