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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
Formulation / Manufacturing:see details

Clinical Trials for: cisapride monohydrate

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

Country Document Number Publication Date
Germany69326063Mar 16, 2000
JapanH04503959Jul 16, 1992
Czech Republic283882Jun 17, 1998
Russian Federation2131244Jun 10, 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.

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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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