NDAORALTABLET, EXTENDED RELEASE
Approved
Nov 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
SEROQUEL XR (quetiapine fumarate) by Fosun Pharma is unclear. First approved in 2007.
Drug data last refreshed 1h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROQUEL XR is an extended-release oral tablet formulation of quetiapine fumarate, an atypical antipsychotic approved in 2007. The drug works primarily through dopamine D2 and serotonin 5HT2A receptor antagonism, with an active metabolite (norquetiapine) contributing additional 5HT2A activity. It is indicated for psychiatric and mood disorders, though specific indications are not detailed in the provided data.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling a transition from growth-stage to defensive positioning requiring cost management and line extension 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)
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Started Dec 2010
361 enrolled
Bipolar Depression
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Started Dec 2010
131 enrolled
Acute Bipolar Mania
Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia
Started Nov 2010
75 enrolled
Schizophrenia
A Retrospective NIS to Evaluate the Use of Seroquel XR and IR in the Clinical Practice of Outpatients With Schizophrenia
Started Oct 2010
186 enrolled
Schizophrenia
Seroquel XR in the Long Term Treatment of Schizophrenia
Started Sep 2010
1,606 enrolled
Relapse in Schizophrenia
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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.