incobotulinumtoxinA (Xeomin)
incobotulinumtoxinA is an FDA-licensed reference biologic from Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Xeomin incobotulinumtoxinA
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC
- Approved
- Nov 20, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for incobotulinumtoxinA, in chronological order.
Reference approval
Approval date of the reference incobotulinumtoxinA product.
10 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for incobotulinumtoxinA (Xeomin)?
No 351(k) biosimilars or interchangeable biosimilars referencing incobotulinumtoxinA are listed in the FDA Purple Book yet.
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