Purple Book product · Reference 351(a)

Ryplazim

plasminogen, human-tvmh

351(a)BLA 125659RxLicensed Kedrion Biopharma Inc.

View plasminogen, human-tvmh family Label PDF Open on FDA Purple Book

Jun 04, 2021

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Ryplazim (plasminogen, human-tvmh) is Kedrion Biopharma Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. No biosimilars referencing Ryplazim are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jun 04, 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 04, 1933
94 yr 6 mo ago
First licensure
Date the BLA was first licensed.
Jun 04, 2021
5 yr 2 mo ago
Approval
Approval date of this BLA submission.
Jun 04, 2021
5 yr 2 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 04, 2028
in 1 yr 11 mo

Pharmaceutical detail

Strength

68.8MG

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1906

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
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Change history

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Ryplazim have approved biosimilars?

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

When does Ryplazim lose reference-product exclusivity?

Ryplazim's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jun 04, 1933.

What is Ryplazim's BLA number?

Ryplazim is licensed under BLA 125659, held by Kedrion Biopharma Inc..

When was Ryplazim approved by the FDA?

Ryplazim was first licensed by the FDA on Jun 04, 2021.

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