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Data updated: Mar 10, 2026

RYKINDO

RISPERIDONE
Neurology Approved 2023-01-13
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
Prescription
First Approved
2023-01-13
Routes
INTRAMUSCULAR
Dosage Forms
FOR SUSPENSION, EXTENDED RELEASE

Companies

SHANDONG LUYE
Active Ingredient: RISPERIDONE

RYKINDO Approval History

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What RYKINDO Treats

3 indications

RYKINDO is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Schizophrenia
  • Bipolar Disorder
  • Autistic Disorder
Source: FDA Label

RYKINDO Boxed Warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning Elderly patients with dementia-r...

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RYKINDO FDA Label Details

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Indications & Usage

FDA Label (PDF)

Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder Treatment of irritability associated with autistic disorder 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies ] . 1.2 Bipolar Mania Mon...

โš ๏ธ BOXED WARNING

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis. [s...

RYKINDO Patents & Exclusivity

Latest Patent: Apr 2032

Patents (80 active)

US10406161 Expires Apr 10, 2032
US10098882 Expires Apr 10, 2032
US9532991 Expires Apr 10, 2032
US9446135 Expires Apr 10, 2032
US11110094 Expires Apr 10, 2032
+ 70 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA212849 โ†’ Label: DailyMed โ†’ Patents: FDA Orange Book โ†’ Trials: ClinicalTrials.gov โ†’

Data sourced from official FDA and NIH databases. Click links to verify on original sources.