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  1. pharmadog
  2. ›drugs
  3. ›Amitiza
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lubiprostone

Marketedupdated 3mo ago
by Mallinckrodt LLC
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying lubiprostone

  • —Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipationrecruitingn=34,532
  • phase4Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparationcompletedn=158

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 23, 2027
161 days

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

patents (6)

  • Oct 25, 2027formulationUS 80263931.2y
  • Oct 25, 2027formulationUS 80263931.2y
  • Jan 23, 2027formulationUS 8338639161d
  • Jan 23, 2027formulationUS 8338639161d
  • Jan 23, 2027formulationUS 8779187161d
  • Jan 23, 2027formulationUS 8779187161d

News(1)

  • Takeda says it expects to take $2.5B hit after Amitiza antitrust verdict, with plans to appeal
    Takeda has updated its financial results to reflect costs it could incur after losing an antitrust lawsuit concerning its laxative drug Amitiza. In May, the US District Court in Massachusetts ruled…
    endpoints · 2mo ago
brand
Amitiza
generic
lubiprostone
indication
Opioid-Induced Constipation (OIC)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 38m ago
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