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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, 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-seven NDAs. There are sixteen 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: see list6
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

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

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

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

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INJECTABLE;INTRAMUSCULAR021346Oct 29, 2003RXNo5,965,168*PED<disabled>Y<disabled>
Janssen Pharms
SOLUTION;ORAL020588Jun 10, 1996RXYes5,453,425*PED<disabled>Y<disabled>
Janssen Pharms
TABLET, ORALLY DISINTEGRATING;ORAL021444Dec 23, 2004RXNo5,648,093*PED<disabled>Y<disabled>
West Ward Pharms
TABLET;ORAL078740May 29, 2009DISCNNo<disabled><disabled>
Synthon Pharms
TABLET;ORAL078187Oct 22, 2009DISCNNo<disabled><disabled>
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Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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