drug · Product Intelligence

Varenicline
Pipeline Intelligence

Varenicline: 3 indexed trials, 3 sponsors; 12 linked Orange Book patents and 11 FDA-linked events where matched.

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3Indexed trials
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3Sponsors
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12Orange Book patent links
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11FDA-linked events

Development evidence

NCT00554840University of Maryland, Baltimore · schizophreniaPHASE2
NCT01892813Mark Vander Weg · depressionPHASE3
NCT02473562Amsterdam UMC, location VUmc · parkinsonsPHASE4

FDA / patent evidence

10456396TYRVAYA · app 2139782035-10-19
11224598TYRVAYA · app 2139782035-10-19
11903941TYRVAYA · app 2139782035-10-19
11903942TYRVAYA · app 2139782035-10-19
11903943TYRVAYA · app 2139782035-10-19
11911380TYRVAYA · app 2139782035-10-19
12576080TYRVAYA · app 2139782035-10-19
12653824TYRVAYA · app 2139782035-10-19
9504644TYRVAYA · app 2139782035-10-19
9504645TYRVAYA · app 2139782035-10-19
9532944TYRVAYA · app 2139782035-10-19
9597284TYRVAYA · app 2139782035-10-19

Regulatory context

FDA_APPROVALVARENICLINE TARTRATE · 2025-05-21
FDA_APPROVALVARENICLINE TARTRATE · 2025-05-02
FDA_APPROVALVARENICLINE TARTRATE · 2024-10-01
FDA_APPROVALVARENICLINE TARTRATE · 2024-07-23
FDA_APPROVALVARENICLINE TARTRATE · 2023-12-04
FDA_APPROVALVARENICLINE TARTRATE · 2023-10-23
FDA_APPROVALVARENICLINE TARTRATE · 2023-08-23
FDA_APPROVALVARENICLINE TARTRATE · 2023-08-01
FDA_APPROVALVARENICLINE TARTRATE · 2023-07-25
FDA_APPROVALTYRVAYA · 2021-10-15
FDA_APPROVALVARENICLINE TARTRATE · 2021-08-11

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