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Details for Generic Name: risperidone

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Risperidone is the generic ingredient in three branded drugs marketed by Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Precision Dose, Roxane, Silarx Pharms Inc, Taro, Tris Pharma Inc, Vintage, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Cadista Pharms, Cipla, Mylan, Pliva Hrvatska Doo, Prinston Inc, Prosam Labs, Ratiopharm, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-eight NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for risperidone. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: risperidone

Drug Master File Entries: see list29
Suppliers / Packaging: see list75
Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for Ingredient: risperidone

Tentative approvals for RISPERIDONE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; ORAL1MG/ML

Clinical Trials for: risperidone

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

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

Oral Versus Injectable Risperidone for Treating First-Episode 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

A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Status: Completed Condition: Anorexia Nervosa

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

Courtesy of
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
Dr Reddys Labs Ltd
TABLET, ORALLY DISINTEGRATING;ORAL077328-002Oct 5, 2009RXNo<disabled><disabled>
TABLET;ORAL078528-001Oct 16, 2009RXNo<disabled><disabled>
Pliva Hrvatska Doo
TABLET;ORAL077769-005Oct 16, 2008RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: risperidone

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TABLET, ORALLY DISINTEGRATING;ORAL021444-003Apr 2, 20035,648,093*PED<disabled>
Janssen Pharms
TABLET;ORAL020272-005Dec 29, 19935,158,952*PED<disabled>
Janssen Pharms
TABLET;ORAL020272-002Dec 29, 19934,804,663*PED<disabled>
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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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