interferon beta-1a (Avonex)
interferon beta-1a is an FDA-licensed reference biologic from Biogen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1996
Reference approved
Reference product
Avonex interferon beta-1a
Biogen Inc.
- Approved
- May 17, 1996
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for interferon beta-1a, in chronological order.
Reference approval
Approval date of the reference interferon beta-1a product.
30 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
23 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for interferon beta-1a (Avonex)?
No 351(k) biosimilars or interchangeable biosimilars referencing interferon beta-1a are listed in the FDA Purple Book yet.
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