teplizumab-mzwv (Tzield)
teplizumab-mzwv is an FDA-licensed reference biologic from Provention Bio, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2022
Reference approved
Reference product
Tzield teplizumab-mzwv
Provention Bio, Inc.
- Approved
- Nov 17, 2022
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for teplizumab-mzwv, in chronological order.
Reference approval
Approval date of the reference teplizumab-mzwv product.
3 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 6 mo
Frequently asked questions
Are there biosimilars approved for teplizumab-mzwv (Tzield)?
No 351(k) biosimilars or interchangeable biosimilars referencing teplizumab-mzwv are listed in the FDA Purple Book yet.
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