FDA Purple Book · Reference family
letibotulinumtoxinA-wlbg (Letybo)
letibotulinumtoxinA-wlbg is an FDA-licensed reference biologic from Hugel, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
351(a)BLA 761225
Letybo letibotulinumtoxinA-wlbg
Hugel, Inc.
- Approved
- Feb 29, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for letibotulinumtoxinA-wlbg, in chronological order.
Reference approval
Approval date of the reference letibotulinumtoxinA-wlbg product.
2 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for letibotulinumtoxinA-wlbg (Letybo)?
No 351(k) biosimilars or interchangeable biosimilars referencing letibotulinumtoxinA-wlbg are listed in the FDA Purple Book yet.
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