Purple Book product · Reference 351(a)

Roctavian

valoctocogene roxaparvovec-rvox

351(a)BLA 125720DiscVoluntarily Revoked Biomarin Pharmaceutical Inc.

View valoctocogene roxaparvovec-rvox family Label PDF Open on FDA Purple Book

Jun 29, 2023

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Roctavian (valoctocogene roxaparvovec-rvox) is Biomarin Pharmaceutical Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing Roctavian are listed in the Purple Book yet.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 29, 1930
97 yr 5 mo ago
Approval
Approval date of this BLA submission.
Jun 29, 2023
3 yr 1 mo ago
Today

Pharmaceutical detail

Strength

16X 10E13GENOMES PER ML

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1649

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 Roctavian have approved biosimilars?

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

What is Roctavian's BLA number?

Roctavian is licensed under BLA 125720, held by Biomarin Pharmaceutical Inc..

When was Roctavian approved by the FDA?

Roctavian was approved by the FDA on Jun 29, 2023.

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