drug · Product Intelligence

Donepezil Hydrochloride
Pipeline Intelligence

Donepezil Hydrochloride: 2 indexed trials, 2 sponsors; 0 linked Orange Book patents and 13 FDA-linked events where matched.

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2Indexed trials
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2Sponsors
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0Orange Book patent links
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13FDA-linked events

Development evidence

NCT00688376Eisai Inc. · pain_neuropathyPHASE3
NCT02162251Eisai Co., Ltd. · alzheimersCOMPLETED

FDA / patent evidence

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

Regulatory context

FDA_APPROVALMEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE · 2023-12-15
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2018-07-27
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2016-02-19
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2013-07-24
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2013-07-05
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2013-02-25
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2011-08-29
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2011-05-31
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2011-05-31
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2011-05-31
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2011-05-31
FDA_APPROVALDONEPEZIL HYDROCHLORIDE · 2011-05-31

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