cenegermin-bkbj (Oxervate)
cenegermin-bkbj is an FDA-licensed reference biologic from Domp� farmaceutici S.p.A.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Oxervate cenegermin-bkbj
Domp� farmaceutici S.p.A.
- Approved
- Aug 22, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for cenegermin-bkbj, in chronological order.
Reference approval
Approval date of the reference cenegermin-bkbj product.
7 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
9 mo ago
Frequently asked questions
Are there biosimilars approved for cenegermin-bkbj (Oxervate)?
No 351(k) biosimilars or interchangeable biosimilars referencing cenegermin-bkbj are listed in the FDA Purple Book yet.
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