CISAPRIDE MONOHYDRATE - Generic Drug Details

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 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
DailyMed Link:	CISAPRIDE MONOHYDRATE at DailyMed

Recent Clinical Trials for CISAPRIDE MONOHYDRATE

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

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

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
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993		DISCN	No	No
Janssen Pharms	PROPULSID	cisapride monohydrate	SUSPENSION;ORAL	020398-001	Sep 15, 1995		DISCN	No	No
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997		DISCN	No	No

Expired US Patents for CISAPRIDE MONOHYDRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	PROPULSID	cisapride monohydrate	SUSPENSION;ORAL	020398-001	Sep 15, 1995	4,962,115
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997	4,962,115
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993	4,962,115
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993	4,962,115

CISAPRIDE MONOHYDRATE Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Cisapride Monohydrate?

Cisapride monohydrate historically targeted gastrointestinal motility disorders, primarily gastroparesis and chronic constipation, before regulatory actions limited its use. Currently, its market is negligible in most regions due to safety concerns, but understanding its past and potential future trajectory provides insight into niche or investigational applications.

Pharmacological Context and Regulatory Status

Cisapride is a prokinetic agent that enhances gastrointestinal motility through serotonin receptor agonism. Originally marketed worldwide, it faced bans or restrictions in many countries after reports linked it to QT interval prolongation and cardiac arrhythmias, with the FDA withdrawing it from the U.S. market in 2000. Some countries only permit restricted use in hospital settings under strict monitoring.

Market Size and Revenue

Pre-regulatory restriction, cisapride's peak global market was estimated at approximately USD 300 million in 1998, with revenues concentrated in Japan and Europe. Post-2000, the market collapsed, as most formulations were withdrawn. Currently, available products are limited to unregulated markets or investigational protocols.

Current Market Players

Active presence is limited; some pharmaceutical companies possess leftover inventory or are involved in research. The drug is predominantly used in academic or clinical research settings rather than commercial markets. No major pharmaceutical company markets cisapride monohydrate as a finished product, and no marketing approvals exist in major jurisdictions.

Future Market Potential and Dynamics

Potential revival hinges on reformulation to mitigate safety concerns. The development of selective 5-HT4 receptor agonists devoid of cardiac risk (e.g., prucalopride) has replaced cisapride in clinical practice. Regulatory hurdles and safety issues diminish prospects for traditional cisapride monohydrate devices unless novel delivery systems emerge or new therapeutic niches are identified.

What's the Financial Trajectory of Cisapride Monohydrate?

Historical Revenue

Prior to withdrawal, revenues fluctuated, driven by regional approvals, with peak sales near USD 300 million annually in the late 1990s. Its generic price point was relatively low, with unit sales affected by safety concerns.

Current Market Valuation

As a commercial product, the value is near zero. Any residual revenue derives from research use or unapproved markets. Anticipated clinical or regulatory re-approval could reignite market activity; however, no current pipeline or licensing deals are publicly confirmed.

Investment and R&D Trends

• There is minimal R&D investment tied directly to cisapride monohydrate.
• Companies focusing on safer prokinetics prefer agents like prucalopride, with USD 50 million-plus annual R&D spending.
• Patent expirations and safety issues have deterred investments in reformulation.

Licensing and Patent Landscape

Cisapride patents expired long ago, with no recent patent activity. Its narrow therapeutic index and safety profile complicate patenting future formulations or new indications.

What Are the Main Challenges and Opportunities?

Challenges:

• Safety profile with serious cardiac adverse effects limits use.
• Regulatory hurdles restrict market re-entry.
• Competitive landscape dominated by newer, safer agents.

Opportunities:

• Potential reformulation to mitigate risks, though no active development is disclosed.
• Investigational use in specific research environments.
• Development of derivatives with improved safety and efficacy profiles.

Key Takeaways

• The global commercial market for cisapride monohydrate is effectively extinct, with historical revenues driven by late 1990s approvals.
• Regulatory bans caused the market to collapse; safety concerns remain a barrier.
• Niche research and limited residual inventory sustain minimal activity, but no commercial prospects are being pursued actively.
• Advances in therapeutic alternatives, notably selective 5-HT4 receptor agonists, have replaced cisapride.
• Future growth depends on reformulation to improve safety or discovering new therapeutic indications.

FAQs

Q1: Why was cisapride withdrawn from the market?
A1: It was withdrawn due to reports of serious cardiac side effects, specifically QT interval prolongation and arrhythmias.

Q2: Are there any ongoing clinical trials involving cisapride?
A2: Very few; most involve research use rather than development for commercial sale.

Q3: Can cisapride monohydrate be used outside regulatory approval?
A3: Its use outside approved settings is limited to experimental or investigational settings and carries legal and safety risks.

Q4: Are there safer alternatives to cisapride?
A4: Yes; agents like prucalopride have replaced cisapride with better safety profiles.

Q5: What is the outlook for future development of cisapride?
A5: The outlook is bleak due to safety issues and availability of alternatives, unless novel formulations significantly reduce risks.

References

[1] U.S. Food and Drug Administration. "FDA Drug Recalls: Cisapride." (2000).
[2] Market research reports on gastrointestinal drugs. (1998-2000).
[3] Company filings, industry analysis on prokinetics. (2022).