Purple Book product · Reference 351(a)

Prehevbrio

Hepatitis B Vaccine (Recombinant)

351(a)BLA 125737DiscLicensed VBI Vaccines (Delaware), Inc.

View Hepatitis B Vaccine (Recombinant) family Label PDF Open on FDA Purple Book

Nov 30, 2021

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Prehevbrio (Hepatitis B Vaccine (Recombinant)) is VBI Vaccines (Delaware), Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. No biosimilars referencing Prehevbrio are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Nov 30, 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).
Nov 30, 1933
94 yr ago
First licensure
Date the BLA was first licensed.
Nov 30, 2021
4 yr 8 mo ago
Approval
Approval date of this BLA submission.
Nov 30, 2021
4 yr 8 mo ago
Today

Pharmaceutical detail

Strength

10UG/ML

Dosage form

For Injection

Route

Intramuscular

Presentation

Single-Dose Vial

Center

CBER

License number

2219

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 Prehevbrio have approved biosimilars?

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

When does Prehevbrio lose reference-product exclusivity?

Prehevbrio's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Nov 30, 1933.

What is Prehevbrio's BLA number?

Prehevbrio is licensed under BLA 125737, held by VBI Vaccines (Delaware), Inc..

When was Prehevbrio approved by the FDA?

Prehevbrio was first licensed by the FDA on Nov 30, 2021.

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