drug · Product Intelligence

Gemcitabine
Pipeline Intelligence

Gemcitabine: 5 indexed trials, 2 sponsors; 0 linked Orange Book patents and 9 FDA-linked events where matched.

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5Indexed trials
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2Sponsors
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0Orange Book patent links
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9FDA-linked events

Development evidence

NCT03348904Incyte Corporation · parkinsonsPHASE3
NCT04003636Merck Sharp & Dohme LLC · parkinsonsPHASE3
NCT04191135Merck Sharp & Dohme LLC · parkinsonsPHASE2
NCT05508867Merck Sharp & Dohme LLC · parkinsonsPHASE2
NCT06788912Merck Sharp & Dohme LLC · parkinsonsPHASE2

FDA / patent evidence

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

Regulatory context

FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2023-03-07
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2018-07-20
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2017-12-06
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2016-07-28
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2016-01-05
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2011-07-25
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2011-07-25
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2011-05-16
FDA_APPROVALGEMCITABINE HYDROCHLORIDE · 2011-05-16

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