omidubicel-onlv (OMISIRGE)
omidubicel-onlv is an FDA-licensed reference biologic from Gamida Cell Ltd.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
OMISIRGE omidubicel-onlv
Gamida Cell Ltd.
- Approved
- Apr 17, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for omidubicel-onlv, in chronological order.
Reference approval
Approval date of the reference omidubicel-onlv product.
3 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 11 mo
Frequently asked questions
Are there biosimilars approved for omidubicel-onlv (OMISIRGE)?
No 351(k) biosimilars or interchangeable biosimilars referencing omidubicel-onlv are listed in the FDA Purple Book yet.
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