allogeneic processed thymus tissue-agdc (Rethymic)
allogeneic processed thymus tissue-agdc is an FDA-licensed reference biologic from Sumitomo Pharma America, Inc.. 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 America, Inc.
- 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.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
94 yr 2 mo ago
First licensure
Date allogeneic processed thymus tissue-agdc was first licensed by the FDA.
4 yr 10 mo ago
Reference approval
Approval date of the reference allogeneic processed thymus tissue-agdc product.
4 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 3 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, 1933.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.