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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.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2012

Reference approved

Reference product

351(a)BLA 125400

Gintuit Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen

Organogenesis, Inc.

Approved
Mar 09, 2012
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen, in chronological order.

  1. Reference approval

    Approval date of the reference Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen product.

    14 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (Gintuit)?

No 351(k) biosimilars or interchangeable biosimilars referencing Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen are listed in the FDA Purple Book yet.

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