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Dificid · pharmadog

pharmadog
drugs
Dificid

drug

patient view →

Dificid

Marketedupdated 2mo ago

by Cubist Pharmaceuticals LLC

Approved

community read0 votes

all catalysts(2)

approval · 2

FIDAXOMICIN — FDA approval

FIDAXOMICIN — FDA approval

News(0)

no news has mentioned this drug yet

brand

Dificid

generic

fidaxomicin

indication

Infectious Diarrhea

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 2h ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Jan 24, 2027

201 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (18)

Nov 28, 2034patentUS 9808530*PED
May 28, 2034formulationUS 9808530
Jan 31, 2028patentUS 7378508*PED1.6y
Jan 31, 2028patentUS 7378508*PED1.6y
Jan 31, 2028patentUS 7863249*PED1.6y
Jan 31, 2028patentUS 7863249*PED1.6y
Jan 31, 2028patentUS 8859510*PED1.6y
Jan 31, 2028patentUS 8859510*PED1.6y
Sep 4, 2027patentUS 7906489*PED1.2y
Sep 4, 2027patentUS 7906489*PED1.2y
Jul 31, 2027compositionUS 73785081.1y
Jul 31, 2027compositionUS 73785081.1y
Jul 31, 2027compositionUS 78632491.1y
Jul 31, 2027formulationUS 78632491.1y
Jul 31, 2027method-of-use (U-2741)US 88595101.1y
Jul 31, 2027method-of-use (U-2741)US 88595101.1y
Mar 4, 2027method-of-use (U-2741)US 7906489240d
Mar 4, 2027method-of-use (U-2741)US 7906489240d

FDA exclusivities (2)

Jan 24, 2027ODE-367Orphan Drug (7y)201d
Jan 24, 2027ODE-367Orphan Drug (7y)201d

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top 3

tagApproval4 co-mentions · 2 sources
tagSmall Molecule2 co-mentions · 2 sources
drugFIDAXOMICIN2 co-mentions · 2 sources

Trials studying Dificid

phase3Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicincompletedn=93
phase3A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)completedn=148
phase4Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)completedn=25
phase4A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Populationcompletedn=364
—Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)withdrawn