allogeneic processed thymus tissue-agdc (Rethymic)
allogeneic processed thymus tissue-agdc is an FDA-licensed reference biologic from Sumitomo Pharma Switzerland GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Rethymic allogeneic processed thymus tissue-agdc
Sumitomo Pharma Switzerland GmbH
- Approved
- Oct 08, 2021
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for allogeneic processed thymus tissue-agdc, in chronological order.
First licensure
Date allogeneic processed thymus tissue-agdc was first licensed by the FDA.
4 yr 9 mo ago
Reference approval
Approval date of the reference allogeneic processed thymus tissue-agdc product.
4 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 5 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 7 yr 6 mo
Frequently asked questions
Are there biosimilars approved for allogeneic processed thymus tissue-agdc (Rethymic)?
No 351(k) biosimilars or interchangeable biosimilars referencing allogeneic processed thymus tissue-agdc are listed in the FDA Purple Book yet.
When does allogeneic processed thymus tissue-agdc (Rethymic) lose reference-product exclusivity?
allogeneic processed thymus tissue-agdc's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending October 8, 2033.
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