Purple Book product · Reference 351(a)

mresvia

Respiratory Syncytial Virus Vaccine

351(a)BLA 125796RxLicensed ModernaTX, Inc.

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

May 31, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

mresvia (Respiratory Syncytial Virus Vaccine) is ModernaTX, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing mresvia are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending May 31, 1936.

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 31, 1936
91 yr 5 mo ago
First licensure
Date the BLA was first licensed.
May 31, 2024
2 yr 2 mo ago
Approval
Approval date of this BLA submission.
May 31, 2024
2 yr 2 mo ago
Today

Pharmaceutical detail

Strength

50UG/.5ML

Dosage form

For Injection

Route

Intramuscular

Presentation

Pre-Filled Syringe

Center

CBER

License number

2256

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 mresvia have approved biosimilars?

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

When does mresvia lose reference-product exclusivity?

mresvia's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending May 31, 1936.

What is mresvia's BLA number?

mresvia is licensed under BLA 125796, held by ModernaTX, Inc..

When was mresvia approved by the FDA?

mresvia was first licensed by the FDA on May 31, 2024.

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