Purple Book product · Reference 351(a)

Arexvy

Respiratory Syncytial Virus Vaccine, Adjuvanted

351(a)BLA 125775RxLicensed GlaxoSmithKline Biologicals

View Respiratory Syncytial Virus Vaccine, Adjuvanted family Label PDF Open on FDA Purple Book

May 03, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) is GlaxoSmithKline Biologicals's FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing Arexvy are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending May 03, 1935.

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).
May 03, 1935
92 yr 6 mo ago
First licensure
Date the BLA was first licensed.
May 03, 2023
3 yr 3 mo ago
Approval
Approval date of this BLA submission.
May 03, 2023
3 yr 3 mo ago
Today

Pharmaceutical detail

Strength

120UG/.5ML

Dosage form

For Injection

Route

Intramuscular

Presentation

Single-Dose Vial

Center

CBER

License number

1617

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 Arexvy have approved biosimilars?

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

When does Arexvy lose reference-product exclusivity?

Arexvy's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending May 03, 1935.

What is Arexvy's BLA number?

Arexvy is licensed under BLA 125775, held by GlaxoSmithKline Biologicals.

When was Arexvy approved by the FDA?

Arexvy was first licensed by the FDA on May 03, 2023.

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