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Details for Generic Name: cisapride monohydrate

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Cisapride monohydrate is the generic ingredient in two branded drugs marketed by Janssen Pharms and Janssen Pharma, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-three patent family members in thirty countries.

There is one drug master file entry for cisapride monohydrate.

Summary for Generic Name: cisapride monohydrate

Drug Master File Entries: see list1

Clinical Trials for: cisapride monohydrate

A Study of Cisapride in Premature Infants With Feeding Problems
Status: Terminated Condition: Infant, Premature; Infant, Newborn

A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
Status: Terminated Condition: Gastroesophageal Reflux

An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options
Status: Terminated Condition: Gastroparesis

An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus
Status: Terminated Condition: Gastroparesis; Diabetes Mellitus

Limited Access Protocol for the Use of Oral Cisapride
Status: Completed Condition: Gastroparesis

Aprepitant PO vs Ondansetron IV for Prevention of Postoperative Nausea and Vomiting
Status: Withdrawn Condition: Postoperative Nausea and Vomiting

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
Janssen Pharms
cisapride monohydrate
TABLET;ORAL020210-001Jul 29, 1993DISCNNo<disabled><disabled>
Janssen Pharma
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767-001Nov 7, 1997DISCNNo5,648,093<disabled> <disabled>
Janssen Pharms
cisapride monohydrate
SUSPENSION;ORAL020398-001Sep 15, 1995DISCNNo<disabled><disabled>
Janssen Pharms
cisapride monohydrate
TABLET;ORAL020210-002Dec 23, 1993DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: cisapride monohydrate

Country Document Number Publication Date
Finland945198Nov 04, 1994
Singapore49249May 18, 1998
Chile2004001180Jun 03, 2005
World Intellectual Property Organization (WIPO)9323017Nov 25, 1993
Denmark0460185Sep 27, 1999
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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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