drug · Product Intelligence

Naltrexone
Pipeline Intelligence

Naltrexone: 5 indexed trials, 4 sponsors; 8 linked Orange Book patents and 9 FDA-linked events where matched.

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5Indexed trials
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4Sponsors
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8Orange Book patent links
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9FDA-linked events

Development evidence

NCT00015080National Institute on Drug Abuse (NIDA) · other_psychiatryPHASE2
NCT00124839Central Institute of Mental Health, Mannheim · other_psychiatryPHASE3
NCT01721330Massachusetts General Hospital · adhdPHASE4
NCT01873729Massachusetts General Hospital · adhdPHASE4
NCT02557984University of Zurich · substance_useNA

FDA / patent evidence

8623418EMBEDA · app 0223212029-11-07
7919499VIVITROL · app 0218972029-10-15
7815934EMBEDA · app 0223212027-12-12
7815934TROXYCA ER · app 2076212027-12-12
7682633EMBEDA · app 0223212027-06-19
8877247EMBEDA · app 0223212027-06-19
7682634EMBEDA · app 0223212027-06-19
8158156EMBEDA · app 0223212027-06-19
8846104EMBEDA · app 0223212027-06-19

Regulatory context

FDA_APPROVALNALTREXONE · 2023-07-06
FDA_APPROVALNALTREXONE HYDROCHLORIDE · 2017-07-21
FDA_APPROVALTROXYCA ER · 2016-08-19
FDA_APPROVALNALTREXONE HYDROCHLORIDE · 2011-08-17
FDA_APPROVALEMBEDA · 2009-08-13
FDA_APPROVALVIVITROL · 2006-04-13
FDA_APPROVALNALTREXONE HYDROCHLORIDE · 2002-03-22
FDA_APPROVALNALTREXONE HYDROCHLORIDE · 2000-03-08
FDA_APPROVALNALTREXONE HYDROCHLORIDE · 1999-05-26

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