Drug

Fecal microbiota spores, live

As of the edition of 20 October 2026, Fecal microbiota spores, live is a drug: marketed, first approved in 2023 (US); US protection ends in 2035.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2023
Kind
Unknown
Brand name
Vowst
First approved
26 April 2023 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Aimmune Therapeutics

US protection

US protection ends in 2035.

The reference-product exclusivity ends in 2035. The application that gives this date is held by Aimmune Therapeutics.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Who has held its approvals

CompanyRoleYears
Aimmune TherapeuticsAcquired holder2025 to now
Seres TherapeuticsOriginator2023 to 2025