onabotulinumtoxinA (Botox)
onabotulinumtoxinA 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
Botox onabotulinumtoxinA
AbbVie Inc.
- Approved
- Dec 09, 1991
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for onabotulinumtoxinA, in chronological order.
Reference approval
Approval date of the reference onabotulinumtoxinA product.
35 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 19 d
Frequently asked questions
Are there biosimilars approved for onabotulinumtoxinA (Botox)?
No 351(k) biosimilars or interchangeable biosimilars referencing onabotulinumtoxinA are listed in the FDA Purple Book yet.
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