Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat (StrataGraft)
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat is an FDA-licensed reference biologic from Stratatech Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
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Biosimilars
0
Interchangeables
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Listed patents
2021
Reference approved
Reference product
StrataGraft Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
Stratatech Corporation
- Approved
- Jun 15, 2021
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
94 yr 5 mo ago
First licensure
Date Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat was first licensed by the FDA.
5 yr 2 mo ago
Reference approval
Approval date of the reference Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat product.
5 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 11 mo
Frequently asked questions
Are there biosimilars approved for Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat (StrataGraft)?
No 351(k) biosimilars or interchangeable biosimilars referencing Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat are listed in the FDA Purple Book yet.
When does Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat (StrataGraft) lose reference-product exclusivity?
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending June 15, 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.
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