NDAORALCAPSULE
Approved
Jun 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Mechanism of Action
SSRI. Paroxetine capsules are not an estrogen, and its mechanism of action for the treatment of VMS is unknown.
Clinical Trials (5)
Concentration-QT Study of Paroxetine in Healthy Adults
Started Oct 2023
38 enrolled
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
Started Dec 2020
38 enrolled
Anxiety Disorders
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Started May 2018
85 enrolled
Anxiety Disorders
Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
Started Nov 2016
361 enrolled
Healthy Volunteers
Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers
Started Jan 2016
24 enrolled
Healthy
Loss of Exclusivity
LOE Date
Apr 6, 2029
37 months away
Patent Expiry
Apr 6, 2029