Purple Book product · Reference 351(a)

StrataGraft

Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat

351(a)BLA 125730DiscVoluntarily Revoked Stratatech Corporation

View Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat family Open on FDA Purple Book

Jun 15, 2021

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

StrataGraft (Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is Stratatech Corporation's FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. No biosimilars referencing StrataGraft are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jun 15, 1933.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Jun 15, 1933
94 yr 5 mo ago
First licensure
Date the BLA was first licensed.
Jun 15, 2021
5 yr 2 mo ago
Approval
Approval date of this BLA submission.
Jun 15, 2021
5 yr 2 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 15, 2028
in 1 yr 11 mo

Pharmaceutical detail

Strength

100CM SQUARED

Dosage form

Cell Sheets

Route

Topical

Presentation

Pouch

Center

CBER

License number

2144

Product number

001

Submission type

Original

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does StrataGraft have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing StrataGraft are listed in the FDA Purple Book yet.

When does StrataGraft lose reference-product exclusivity?

StrataGraft's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jun 15, 1933.

What is StrataGraft's BLA number?

StrataGraft is licensed under BLA 125730, held by Stratatech Corporation.

When was StrataGraft approved by the FDA?

StrataGraft was first licensed by the FDA on Jun 15, 2021.

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