drug
Dificid
Marketedupdated 3mo agoby Cubist Pharmaceuticals LLC
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3all catalysts(2)
Trials studying Dificid
- phase3Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
- 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)
- phase4Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
- 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 Population
- —Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 24, 2027
159 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*PED1.5y
- Jan 31, 2028patentUS 7378508*PED1.5y
- Jan 31, 2028patentUS 7863249*PED1.5y
- Jan 31, 2028patentUS 7863249*PED1.5y
- Jan 31, 2028patentUS 8859510*PED1.5y
- Jan 31, 2028patentUS 8859510*PED1.5y
- Sep 4, 2027patentUS 7906489*PED1.0y
- Sep 4, 2027patentUS 7906489*PED1.0y
- Jul 31, 2027compositionUS 7378508347d
- Jul 31, 2027compositionUS 7378508347d
- Jul 31, 2027compositionUS 7863249347d
- Jul 31, 2027formulationUS 7863249347d
- Jul 31, 2027method-of-use (U-2741)US 8859510347d
- Jul 31, 2027method-of-use (U-2741)US 8859510347d
- Mar 4, 2027method-of-use (U-2741)US 7906489198d
- Mar 4, 2027method-of-use (U-2741)US 7906489198d
FDA exclusivities (2)
- Jan 24, 2027ODE-367Orphan Drug (7y)159d
- Jan 24, 2027ODE-367Orphan Drug (7y)159d
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