Purple Book reference family · 351(a) biologic
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (Gintuit)
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen is an FDA-licensed reference biologic from Organogenesis, Inc..
351(a) biologicBLA 125400 Organogenesis, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2012
Reference product
Originator biologic
351(a)BLA 125400
Gintuit Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
Organogenesis, Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen product.
14 yr 7 mo ago
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
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