drug · Product Intelligence

Fluoxetine
Pipeline Intelligence

Fluoxetine: 10 indexed trials, 10 sponsors; 0 linked Orange Book patents and 14 FDA-linked events where matched.

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10Indexed trials
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10Sponsors
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0Orange Book patent links
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14FDA-linked events

Development evidence

NCT00035321Eli Lilly and Company · depressionPHASE3
NCT00515320Neuropharm · autismPHASE3
NCT00573547Creighton University · depressionPHASE4
NCT00592852Massachusetts General Hospital · bipolar_disorderPHASE4
NCT00873834Assistance Publique - Hôpitaux de Paris · autismPHASE2
NCT00986310University of California, Davis · epilepsyNA
NCT01360190University of California, Los Angeles · depressionPHASE4
NCT01372150Pfizer · depressionPHASE3
NCT01740726Emory University · depressionNA
NCT02683213Karolinska Institutet · strokePHASE3

FDA / patent evidence

Orange Book match found; no listed patent relation was retained for this product match.

Regulatory context

FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2022-11-09
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2020-08-27
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2019-02-08
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2016-10-21
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2012-10-01
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2009-03-19
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2008-11-17
FDA_APPROVALSARAFEM · 2006-05-19
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2004-12-13
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2004-09-28
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2002-01-30
FDA_APPROVALFLUOXETINE HYDROCHLORIDE · 2002-01-29

FDA Orange Book coverage is U.S.-specific and is not a substitute for worldwide patent or regulatory review.