National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 2
1969-12-31
This study is a double-blind, placebo-controlled outpatient trial to improve, through the
addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent
individuals currently taking naltrexone (Revia).
Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Completed
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 2
1969-12-31
This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption
and crime-related post-traumatic stress disorder in those individuals with both disorders.
This will be a 12-week, placebo-controlled, double-blind outpatient trial.
All subjects will receive cognitive behavioral therapy in addition to a placebo or
sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and
6, 9, and 12 months after study entry.
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Completed
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 2
2003-01-01
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in
Alaska natives with alcohol dependence. The study will also examine whether a combination of
naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone.
Alaska Native individuals will be recruited into a 16 week outpatient study.
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Completed
Yale University
Phase 2
2003-01-01
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in
Alaska natives with alcohol dependence. The study will also examine whether a combination of
naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone.
Alaska Native individuals will be recruited into a 16 week outpatient study.
Sertraline and Cognitive Therapy in Depressed Alcoholics
Completed
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 2
1969-12-31
This study will assess whether individuals treated with sertraline (Zoloft) and cognitive
behavior therapy will experience improvement with their depression and consume less alcohol
than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week,
random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3
months after treatment.
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Last updated: July 28, 2026
Zoloft (sertraline) clinical trials update, market analysis, and exclusivity timeline for generics and biosimilars
Zoloft is an established, off-patent branded antidepressant (SSRI) with broad generic penetration in the US and other markets. No new exclusivity anchor is required for near-term generics because multiple sertraline formulations and strengths already have generic availability. The market is now driven by (1) share shifts among manufacturers, (2) pharmacy benefit design and substitution, and (3) patent- and formulation-scoped litigation or regulatory workarounds for specific product variants.
High-level market reality check
Active ingredient: sertraline (SSRI)
Drug class: antidepressant for major depressive disorder, OCD, panic disorder, PTSD, social anxiety disorder
Branded product: Zoloft
Core commercial dynamic: generic competition suppresses Zoloft revenue and limits upside to incremental share and contracted market access, rather than supply-constrained growth.
Clinical trials posture
Clinical research activity continues, but for an off-patent small molecule it is typically concentrated in:
new combinations, line extensions (dose forms, pediatric subpopulations), or label refinements
postmarketing comparative and safety studies
biomarker or digital-phenotyping studies that do not create commercial exclusivity
The practical business question is not “will sertraline gain new IP,” but “will any new patent-protected formulation or method-of-use slow generics or enable a new branded lifecycle product.”
(No reliable, complete, up-to-date clinical-trial and IP dataset for Zoloft can be produced from the information provided in this prompt.)
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