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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, Ranbaxy, 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 fourty-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

Tradenames:3
Patents:12
Applicants:37
NDAs:48
Drug Master File Entries: see list29
Suppliers: see list6
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

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

A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Status: Active, not recruiting Condition: Anorexia Nervosa

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prosam Labs
RISPERIDONE
risperidone
TABLET;ORAL078071-004Jun 17, 2009RXNo<disabled><disabled>
Janssen Pharms
RISPERDAL
risperidone
TABLET;ORAL020272-007Jan 27, 1999RXNo<disabled><disabled>
Mylan Pharms Inc
RISPERIDONE
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL091537-005Mar 30, 2011RXNo<disabled><disabled>
Mylan
RISPERIDONE
risperidone
TABLET;ORAL076288-003Sep 15, 2008RXNo<disabled><disabled>
Par Pharm
RISPERIDONE
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL077494-006Apr 30, 2009RXNo<disabled><disabled>
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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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