beractant (Survanta)
beractant is an FDA-licensed reference biologic from AbbVie Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1991
Reference approved
Reference product
Survanta beractant
AbbVie Inc.
- Approved
- Jul 01, 1991
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for beractant, in chronological order.
Reference approval
Approval date of the reference beractant product.
35 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
28 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for beractant (Survanta)?
No 351(k) biosimilars or interchangeable biosimilars referencing beractant are listed in the FDA Purple Book yet.
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