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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

Tradenames:2
Patents:1
Applicants:2
NDAs:3
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Status: Withdrawn Condition: Postoperative Nausea and Vomiting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 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
PROPULSID
cisapride monohydrate
TABLET;ORAL020210-002Dec 23, 1993DISCNNo<disabled><disabled>
Janssen Pharms
PROPULSID
cisapride monohydrate
TABLET;ORAL020210-001Jul 29, 1993DISCNNo<disabled><disabled>
Janssen Pharma
PROPULSID QUICKSOLV
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767-001Nov 7, 1997DISCNNo5,648,093<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: cisapride monohydrate

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
PROPULSID
cisapride monohydrate
SUSPENSION;ORAL020398-001Sep 15, 19954,962,115<disabled>
Janssen Pharms
PROPULSID
cisapride monohydrate
TABLET;ORAL020210-002Dec 23, 19934,962,115<disabled>
Janssen Pharma
PROPULSID QUICKSOLV
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767-001Nov 7, 19974,962,115<disabled>
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International Patent Family for Ingredient: cisapride monohydrate

Country Document Number Publication Date
JapanH07508019Sep 07, 1995
Slovakia280129Aug 06, 1999
El Salvador1998000062Nov 05, 1998
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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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