abobotulinumtoxinA (Dysport)
abobotulinumtoxinA is an FDA-licensed reference biologic from Ipsen Biopharm Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2009
Reference approved
Reference product
Dysport abobotulinumtoxinA
Ipsen Biopharm Limited
- Approved
- Apr 29, 2009
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for abobotulinumtoxinA, in chronological order.
Reference approval
Approval date of the reference abobotulinumtoxinA product.
17 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
2 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for abobotulinumtoxinA (Dysport)?
No 351(k) biosimilars or interchangeable biosimilars referencing abobotulinumtoxinA are listed in the FDA Purple Book yet.
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