Fidaxomicin

Treats C. difficile -associated diarrhea. Sold as Dificid. Every FDA application for this active ingredient: 2 branded and 5 generic.

As of Nov 15, 2026, FDA lists 7 applications for Fidaxomicin (sold as Dificid), first approved May 27, 2011, with 2 new uses approved and 0 published complete response letters.

First approved: May 27, 2011
Applications: 7
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $178M
Orphan exclusivity until: Jan 24, 2027
First approved in the EU: Dec 5, 2011
First approved in Japan: Jul 2, 2018

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Dificid	Part D	$131M	-15%	21,318
Fidaxomicin	Part D	$47.8M	New	10,722

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FIDAXOMICIN 200 MG TABLET: $88.17 per unitGeneric · new this year
DIFICID 200 MG TABLET: $248.28 per unitBrand · 0% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of pediatric Clostridium difficile infectionCubist Pharmaceuticals LLC, a subsidiary of Merck Sharp & Dohme LLC · designated Dec 13, 2010 · approved Jan 24, 2020 · exclusive to Jan 24, 2027

Approvals in the EU (EMA)

First approved in the EU 6 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Dificlir, new substanceTillotts Pharma GmbH · Dec 5, 2011

Approvals in Japan (PMDA)

First approved in Japan 85 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Dafclir, new ingredientA drug with a new active ingredient indicated for the treatment of infectious enteritis (including pseudomembranous colitis) caused by C. · Astellas Pharma Inc. · Jul 2, 2018

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Vancomycin Taper to Prevent Recurrent Clostridioides DifficileClostridia Difficile Colitis · McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 3	Recruiting	Jan 9, 2026
STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile InfectionClostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence · Medical University of Warsaw	Not applicable	Not yet recruiting	Aug 13, 2025
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard TherapyClostridioides Difficile Infection · Medical College of Wisconsin	Early phase 1	Recruiting	Mar 19, 2025
Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Disease (IBD), Clostridioides Difficile Infection · Brigham and Women's Hospital	Phase 4	Not yet recruiting	Jan 27, 2025
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First RecurrenceClostridioides Difficile Infection · Benoit Guery	Phase 3	Recruiting	Mar 4, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 27, 2011	DificidNDA 201699 · New molecular entity	Cubist Pharms LLC	10	Marketed
Jan 24, 2020	DificidNDA 213138 · New formulation or manufacturer	Cubist Pharms LLC	1	Marketed
Jan 16, 2024	FidaxomicinANDA 208443	Actavis Labs Fl	0	Marketed
Jan 27, 2026	FidaxomicinANDA 220374	Torrent	0	Marketed
Feb 2, 2026	FidaxomicinANDA 219559	Apotex	0	Marketed
Aug 13, 2026	FidaxomicinANDA 220465	Sandoz	0	Marketed
Oct 7, 2026	FidaxomicinANDA 219737	Hikma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA