Purple Book product · Reference 351(a)

Rethymic

allogeneic processed thymus tissue-agdc

351(a)BLA 125685RxLicensed Sumitomo Pharma America, Inc.

View allogeneic processed thymus tissue-agdc family Label PDF Open on FDA Purple Book

Oct 08, 2021

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Rethymic (allogeneic processed thymus tissue-agdc) is Sumitomo Pharma America, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. No biosimilars referencing Rethymic are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Oct 08, 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).
Oct 08, 1933
94 yr 2 mo ago
First licensure
Date the BLA was first licensed.
Oct 08, 2021
4 yr 10 mo ago
Approval
Approval date of this BLA submission.
Oct 08, 2021
4 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 08, 2028
in 2 yr 3 mo

Pharmaceutical detail

Strength

SEMI-QUANTITATIVE

Dosage form

For Suspension

Route

Implantation

Presentation

Dish

Center

CBER

License number

2368

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

v8Jul 02, 2026
v7Jul 02, 2026
v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Rethymic have approved biosimilars?

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

When does Rethymic lose reference-product exclusivity?

Rethymic's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Oct 08, 1933.

What is Rethymic's BLA number?

Rethymic is licensed under BLA 125685, held by Sumitomo Pharma America, Inc..

When was Rethymic approved by the FDA?

Rethymic was first licensed by the FDA on Oct 08, 2021.

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