NDAORALTABLET
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
SEROQUEL (quetiapine) by Aurobindo Pharma is unclear. First approved in 1997.
Drug data last refreshed 6h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROQUEL (quetiapine) is an oral atypical antipsychotic approved in 1997 for schizophrenia, bipolar disorder, and major depressive disorder. It works primarily through dopamine D2 and serotonin 5HT2A receptor antagonism, with an active metabolite (norquetiapine) contributing additional 5HT2A activity. The mechanism remains incompletely characterized but is believed to involve combined monoamine modulation.
$10MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending; likely smaller, defensive teams focused on market share retention rather than expansion.
Mechanism of Action
unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2A (5HT 2A ) antagonism. The active metabolite, N-desalkyl quetiapine (norquetiapine), has similar activity at D 2 , but greater activity at 5HT 2A…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Started Nov 2020
389 enrolled
Depressive Disorder, Major
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Started Sep 2020
757 enrolled
Depressive Disorder, Major
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
Started Aug 2020
676 enrolled
Depressive Disorder, Major
Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
Started Oct 2019
11 enrolled
Parkinson's Disease
Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
Started Mar 2019
58 enrolled
Bipolar DisorderSchizophrenia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.