rimabotulinumtoxinB (Myobloc)
rimabotulinumtoxinB is an FDA-licensed reference biologic from Solstice NeuroSciences, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2000
Reference approved
Reference product
Myobloc rimabotulinumtoxinB
Solstice NeuroSciences, LLC
- Approved
- Dec 08, 2000
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for rimabotulinumtoxinB, in chronological order.
Reference approval
Approval date of the reference rimabotulinumtoxinB product.
25 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
18 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for rimabotulinumtoxinB (Myobloc)?
No 351(k) biosimilars or interchangeable biosimilars referencing rimabotulinumtoxinB are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.