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Profile for Tradename: RISPERDAL CONSTA

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Risperdal Consta is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug.

The generic ingredient in RISPERDAL CONSTA is risperidone. There are twenty-nine drug master file entries for this compound. Six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the risperidone profile page.

Summary for Tradename: RISPERDAL CONSTA

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Clinical Trials for: RISPERDAL CONSTA

Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)
Status: Completed Condition: Schizophrenia

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Status: Completed Condition: Healthy

Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Status: Completed Condition: Schizophrenia

Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Status: Completed Condition: Schizophrenia; Psychotic Disorders; Substance Abuse; Alcohol Abuse

An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia
Status: Terminated Condition: Schizophrenia

Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
Status: Completed Condition: Schizophrenia

Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
Status: Completed Condition: Schizophrenia

An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder
Status: Completed Condition: Schizophrenia

Risperdal Consta for Bipolar Disorder
Status: Completed Condition: Bipolar I Disorder

Bioequivalence Test for Risperdal 2mg of Janssen Korea
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-003Oct 29, 2003RXNo6,194,006*PED<disabled>Y<disabled>
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-003Oct 29, 2003RXNo5,916,598*PED<disabled>Y<disabled>
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-004Apr 12, 2007RXNo6,596,316*PED<disabled>Y<disabled>
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Expired Patents for Tradename: RISPERDAL CONSTA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-003Oct 29, 20035,965,168*PED<disabled>
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-001Oct 29, 20035,688,801*PED<disabled>
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-004Apr 12, 20074,804,663*PED<disabled>
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Non-Orange Book Patents for Tradename: RISPERDAL CONSTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,799,345Preparation of injectable suspensions having improved injectability<disabled in preview>
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent<disabled in preview>
5,965,168 Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles<disabled in preview>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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