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FECAL MICROBIOTA SPORES, LIVE
Fecal Microbiota Spores, Live is a marketed therapy primarily indicated for the prevention of recurrent Clostridioides difficile infection (CDI), positioning it in a niche but critical segment of the gastrointestinal therapeutic area. The key strength of this product lies in its unique mechanism of action, which leverages live spores to restore gut microbiota balance, offering a novel approach to managing recurrent CDI. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | FECAL MICROBIOTA SPORES, LIVE |
|---|---|
| Phase | FDA-approved |
| First approval | 2023 |
Approved indications
- Prevention of recurrent CDI
Common side effects
- Abdominal distension
- Fatigue
- Constipation
- Chills
- Diarrhea
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FECAL MICROBIOTA SPORES, LIVE CI brief — competitive landscape report
- FECAL MICROBIOTA SPORES, LIVE updates RSS · CI watch RSS