NDAORALTABLET, EXTENDED RELEASE
Approved
May 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
SEROQUEL XR (quetiapine) by Aurobindo Pharma is unclear. First approved in 2007.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROQUEL XR is an extended-release oral tablet formulation of quetiapine, an atypical antipsychotic approved in 2007. It works primarily through dopamine D2 and serotonin 5-HT2A receptor antagonism, with its active metabolite norquetiapine contributing additional 5-HT2A activity. The drug treats schizophrenia, bipolar disorder, and major depressive disorder as an adjunctive therapy.
$9MPart D
LOE ApproachingProduct is in late-cycle maturity with modest Part D claims; commercial teams should anticipate generic competition and focus on patient retention and payer strategies.
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.