Purple Book product · Reference 351(a)

Vowst

fecal microbiota spores, live-brpk

351(a)BLA 125757RxLicensed Aimmune Therapeutics, Inc.

View fecal microbiota spores, live-brpk family Label PDF Open on FDA Purple Book

Apr 26, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Vowst (fecal microbiota spores, live-brpk) is Aimmune Therapeutics, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing Vowst are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Apr 26, 1935.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 26, 1930
97 yr 8 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Apr 26, 1935
92 yr 7 mo ago
First licensure
Date the BLA was first licensed.
Apr 26, 2023
3 yr 3 mo ago
Approval
Approval date of this BLA submission.
Apr 26, 2023
3 yr 3 mo ago
Today

Pharmaceutical detail

Strength

1X10 LOG 6 AND 3X10 LOG 7CFU/TAB

Dosage form

Capsule

Route

Oral

Presentation

Bottle

Center

CBER

License number

2109

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 Vowst have approved biosimilars?

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

When does Vowst lose reference-product exclusivity?

Vowst's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Apr 26, 1935.

What is Vowst's BLA number?

Vowst is licensed under BLA 125757, held by Aimmune Therapeutics, Inc..

When was Vowst approved by the FDA?

Vowst was first licensed by the FDA on Apr 26, 2023.

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