Cisapride monohydrate - Generic Drug Details

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What are the generic sources for cisapride monohydrate and what is the scope of freedom to operate?

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

There is one drug master file entry for cisapride monohydrate.

Summary for cisapride monohydrate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	1
Patent Applications:	325
DailyMed Link:	cisapride monohydrate at DailyMed

Recent Clinical Trials for cisapride monohydrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all cisapride monohydrate clinical trials

Medical Subject Heading (MeSH) Categories for cisapride monohydrate

Anti-Ulcer Agents
Gastrointestinal Agents
Serotonin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for cisapride monohydrate

A03FA	Propulsives
A03F	PROPULSIVES
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for cisapride monohydrate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	PROPULSID	cisapride monohydrate	SUSPENSION;ORAL	020398-001	Sep 15, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cisapride monohydrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	PROPULSID	cisapride monohydrate	SUSPENSION;ORAL	020398-001	Sep 15, 1995	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993	⤷ Sign Up	⤷ Sign Up
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997	⤷ Sign Up	⤷ Sign Up
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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