Purple Book product · Reference 351(a)

Rebyota

fecal microbiota, live-jslm

351(a)BLA 125739RxLicensed Ferring Pharmaceuticals Inc.

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

Nov 30, 2022

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Rebyota (fecal microbiota, live-jslm) is Ferring Pharmaceuticals Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Rebyota are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Nov 30, 1934.

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, 1934
93 yr ago
First licensure
Date the BLA was first licensed.
Nov 30, 2022
3 yr 8 mo ago
Approval
Approval date of this BLA submission.
Nov 30, 2022
3 yr 8 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 30, 2029
in 3 yr 5 mo

Pharmaceutical detail

Strength

BETWEEN 1X10^8 AND 5X10^10CFU

Dosage form

Suspension

Route

Rectal

Presentation

Single-Use Bottle

Center

CBER

License number

2112

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 Rebyota have approved biosimilars?

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

When does Rebyota lose reference-product exclusivity?

Rebyota's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Nov 30, 1934.

What is Rebyota's BLA number?

Rebyota is licensed under BLA 125739, held by Ferring Pharmaceuticals Inc..

When was Rebyota approved by the FDA?

Rebyota was first licensed by the FDA on Nov 30, 2022.

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