tarlatamab-dlle (Imdelltra)
tarlatamab-dlle is an FDA-licensed reference biologic from Amgen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Imdelltra tarlatamab-dlle
Amgen Inc.
- Approved
- May 16, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tarlatamab-dlle, in chronological order.
Reference approval
Approval date of the reference tarlatamab-dlle product.
2 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr
Frequently asked questions
Are there biosimilars approved for tarlatamab-dlle (Imdelltra)?
No 351(k) biosimilars or interchangeable biosimilars referencing tarlatamab-dlle are listed in the FDA Purple Book yet.
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