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Last Updated: May 14, 2021

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CISAPRIDE MONOHYDRATE - Generic Drug Details

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What are the generic drug 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 are two drug master file entries for cisapride monohydrate.

Recent Clinical Trials for CISAPRIDE MONOHYDRATE

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all CISAPRIDE MONOHYDRATE clinical trials

Medical Subject Heading (MeSH) Categories for CISAPRIDE MONOHYDRATE

US Patents and Regulatory Information for CISAPRIDE MONOHYDRATE

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 SUSPENSION;ORAL 020398-001 Sep 15, 1995 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Janssen Pharms PROPULSID cisapride monohydrate TABLET;ORAL 020210-001 Jul 29, 1993 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Janssen Pharms PROPULSID cisapride monohydrate TABLET;ORAL 020210-002 Dec 23, 1993 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Janssen Pharma PROPULSID QUICKSOLV cisapride monohydrate TABLET, ORALLY DISINTEGRATING;ORAL 020767-001 Nov 7, 1997 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma PROPULSID QUICKSOLV cisapride monohydrate TABLET, ORALLY DISINTEGRATING;ORAL 020767-001 Nov 7, 1997   Get Started for $10   Get Started for $10
Janssen Pharms PROPULSID cisapride monohydrate SUSPENSION;ORAL 020398-001 Sep 15, 1995   Get Started for $10   Get Started for $10
Janssen Pharms PROPULSID cisapride monohydrate TABLET;ORAL 020210-001 Jul 29, 1993   Get Started for $10   Get Started for $10
Janssen Pharms PROPULSID cisapride monohydrate TABLET;ORAL 020210-002 Dec 23, 1993   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Boehringer Ingelheim
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Harvard Business School

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