Purple Book product · Reference 351(a)
Intron A
interferon alfa-2b
Not listed
Approved
Reference 351(a)
License type
Disc
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 21, 1995
31 yr 1 mo ago
Today
Pharmaceutical detail
Strength
25MIU
Dosage form
Injection
Route
Intralesional, Intramuscular, Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
0002
Product number
011
Submission type
Supplement
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.
13 additional BLA records for this product (other strengths or presentations) are in the same reference family.
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 Intron A have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Intron A are listed in the FDA Purple Book yet.
What is Intron A's BLA number?
Intron A is licensed under BLA 103132, held by Merck Sharp & Dohme LLC.
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.
