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.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
97 yr 8 mo ago
Reference approval
Approval date of the reference omidubicel-onlv product.
3 yr 4 mo ago
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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.