talquetamab-tgvs (Talvey)
talquetamab-tgvs is an FDA-licensed reference biologic from Janssen Biotech, Inc.. 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
Talvey talquetamab-tgvs
Janssen Biotech, Inc.
- Approved
- Aug 09, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for talquetamab-tgvs, in chronological order.
Reference approval
Approval date of the reference talquetamab-tgvs product.
2 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 3 mo
Frequently asked questions
Are there biosimilars approved for talquetamab-tgvs (Talvey)?
No 351(k) biosimilars or interchangeable biosimilars referencing talquetamab-tgvs are listed in the FDA Purple Book yet.
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