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.

Summary for CISAPRIDE MONOHYDRATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
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
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

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	020210-001	Jul 29, 1993		DISCN	No	No
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997		DISCN	No	No
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993		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	TABLET;ORAL	020210-001	Jul 29, 1993	4,962,115
Janssen Pharms	PROPULSID	cisapride monohydrate	SUSPENSION;ORAL	020398-001	Sep 15, 1995	4,962,115
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993	4,962,115

Cisapride Monohydrate Market Dynamics and Financial Trajectory

Last updated: September 1, 2026

Cisapride monohydrate has no material branded human pharmaceutical market in the United States or most major regulated markets. The product was withdrawn after serious cardiac safety risks, including QT prolongation, torsades de pointes, ventricular arrhythmias and sudden death. Current commercial activity is limited primarily to pharmaceutical-grade active ingredient supply, extemporaneous compounding and veterinary use. Public revenue data for cisapride monohydrate are not reported as a standalone category.

What is the current market status of cisapride monohydrate?

Cisapride monohydrate is the monohydrate form of cisapride, a gastrointestinal prokinetic agent that increases gastrointestinal motility through serotonin 5-HT4 receptor activity. Its historical branded product was Propulsid, marketed by Janssen Pharmaceuticals.

The market has shifted through four stages:

Period	Market condition	Commercial implication
1993-1999	Broad human prescription use in the United States	Branded-product revenue and large prescription base
2000-2004	U.S. withdrawal followed by restricted access	Rapid collapse in ordinary retail sales
2004-present	No conventional U.S. human commercial market	Demand limited to compounding and specialized channels
Current period	Small, fragmented, risk-sensitive market	Low-volume API and veterinary demand

Janssen voluntarily discontinued U.S. marketing of Propulsid effective March 14, 2000, after reports associated cisapride with serious cardiac events. The Food and Drug Administration subsequently allowed restricted access for selected patients through a limited-access program before the product was fully removed from routine U.S. distribution [1, 2].

Cisapride remains available in some countries under differing regulatory conditions, but it does not have the broad international commercial footprint of a conventional gastrointestinal medicine. Country-level availability has been shaped by cardiac safety restrictions, local withdrawal decisions and the availability of alternative prokinetic therapies.

When did cisapride lose exclusivity and commercial value?

Cisapride’s commercial exclusivity ended functionally through safety-driven withdrawal rather than through ordinary patent expiry.

The product had already achieved substantial market penetration before the safety issue became decisive. Once routine U.S. marketing ended, the value of the brand, sales infrastructure and physician-prescribing base fell sharply. Any remaining patent rights had limited practical value because regulatory access, prescriber acceptance and reimbursement were more restrictive than the underlying intellectual-property position.

Cisapride commercial timeline

Date	Event	Financial effect
1980s-early 1990s	Development and regulatory filings for cisapride	Creation of originator asset
July 1993	FDA approval of Propulsid in the United States	Launch of branded revenue stream
Mid-to-late 1990s	Reports of serious cardiac arrhythmias and drug interactions	Rising liability, monitoring and regulatory risk
January 2000	Janssen announced voluntary withdrawal from the U.S. market	Expected U.S. revenue reset
March 14, 2000	U.S. commercial distribution discontinued	Retail market effectively ended
2000-2004	Restricted-access availability for selected patients	Residual, non-routine demand
After 2004	No ordinary U.S. commercial human market	Compounding and veterinary channels remained

Janssen’s decision converted cisapride from a high-volume branded medicine into a controlled-access product. The financial impact extended beyond lost sales. The withdrawal also increased legal exposure, medical-affairs costs, pharmacovigilance requirements and the probability that physicians would substitute safer alternatives.

How large was the cisapride market before withdrawal?

Public sources do not provide a consistently reported, standalone global revenue series for cisapride monohydrate. Historical commercial estimates generally identify Propulsid as a major product before withdrawal, but sales figures vary by reporting year, geography and whether related formulations are included.

The United States was the principal value driver because Propulsid was used broadly for gastroesophageal reflux disease and other gastrointestinal motility indications. Its prescription base was materially larger than the current market for compounded cisapride.

The pre-withdrawal revenue model had four characteristics:

1. A branded prescription product with broad physician awareness.
2. High-volume treatment of common gastrointestinal disorders.
3. Originator-controlled commercial distribution.
4. Limited substitution pressure before safety concerns became prominent.

The post-withdrawal model has the opposite characteristics:

1. Low and fragmented prescription volume.
2. Patient-specific compounding.
3. Veterinary demand in selected indications.
4. No large-scale branded promotion.
5. Greater regulatory and quality-control scrutiny.

What are the current revenue drivers for cisapride monohydrate?

Current revenue is generated through narrow channels rather than through mass-market pharmaceutical sales.

Human compounding

Cisapride may be compounded for individual patients in jurisdictions where local law permits access and a prescriber determines that use is appropriate. Compounded products are typically prepared as capsules, suspensions or other dosage forms tailored to patient needs.

This channel has limited scalability because:

• Prescriptions are patient-specific.
• Pharmacies must manage specialized sourcing and quality controls.
• Cardiac contraindications and drug-interaction risks restrict use.
• The product lacks the commercial support infrastructure of an approved branded drug.
• Reimbursement can be inconsistent.

Compounding demand is therefore price-sensitive but not necessarily commoditized. Pharmacies and suppliers must maintain reliable API quality, documentation and testing. Supply interruptions can affect patients because alternative commercially manufactured products are limited.

Veterinary use

Veterinary compounding is the most durable niche for cisapride in the United States. Veterinarians may prescribe compounded cisapride for gastrointestinal motility disorders in animals, including conditions involving constipation, megacolon and postoperative gastrointestinal dysfunction.

The veterinary segment has stronger recurring demand than human compounding because:

• Prescriptions are concentrated among specialty and referral practices.
• Treatment can be chronic or recurrent.
• Veterinary formulations can be customized by species and dosage.
• Commercial alternatives may be limited for particular animal patients.

The segment remains regulated through veterinary prescribing and compounding rules. FDA does not treat compounded cisapride as an FDA-approved finished veterinary product merely because a pharmacy prepares it under prescription [3].

API and specialty supply

Manufacturers and distributors can generate revenue by supplying cisapride monohydrate as pharmaceutical-grade API to compounding pharmacies or other authorized users. The addressable market is small, and the principal competitive factors are:

• Certificate-of-analysis quality.
• Identity, potency and impurity control.
• Batch consistency.
• Regulatory documentation.
• Minimum order size.
• Supply continuity.
• Import and distribution compliance.

API pricing can remain relatively firm despite low total volume because the market has fewer qualified suppliers and buyers cannot always substitute freely among suppliers.

What is the FDA regulatory status of cisapride?

Cisapride is not an actively marketed, broadly available FDA-approved human prescription product in the United States. The FDA-approved commercial product, Propulsid, was withdrawn after serious cardiac safety findings.

The central regulatory issue is not ordinary generic competition. It is whether a patient can obtain a compounded product under applicable federal and state rules.

U.S. regulatory position

The U.S. market is divided into:

Channel	Status
Approved branded human product	Withdrawn
Routine retail generic product	Not established as a conventional commercial market
Patient-specific compounding	Possible where legally permitted and clinically prescribed
Outsourcing-facility supply	Subject to applicable FDA compounding requirements
Veterinary compounding	Possible under veterinary and compounding rules
OTC distribution	Not a viable regulatory channel

Cisapride’s safety profile limits the commercial significance of compounding. The drug can interact with medicines that inhibit CYP3A4 and can increase the risk of dangerous cardiac electrophysiology effects. FDA warnings identified particular risk in patients with underlying cardiac disease, electrolyte abnormalities, renal or hepatic impairment and exposure to interacting medicines [1].

What patent protection covers cisapride monohydrate?

Cisapride’s original composition, pharmaceutical formulation and use patents are no longer the main commercial barrier. The originator’s effective market protection has expired or become commercially irrelevant in the principal markets because the product was withdrawn years before current demand emerged.

The current IP position is better characterized as follows:

IP category	Current commercial relevance
Original cisapride compound patents	Expired or no longer commercially decisive
Original Propulsid formulation rights	Expired or commercially inactive
Method-of-use patents	Limited relevance after withdrawal
New dosage-form patents	Possible only for genuinely novel formulations and claims
API manufacturing know-how	More relevant than legacy product patents
Trade secrets and analytical methods	Potential supplier-level barriers
Trademark rights	Limited value without an approved branded product

A company seeking to commercialize cisapride monohydrate today would face regulatory and safety barriers rather than a significant blocking patent estate. New intellectual property could potentially cover a formulation, delivery system, impurity profile or manufacturing process, but such rights would not recreate the historical branded market without a viable regulatory pathway.

How strong is the cisapride monohydrate patent estate?

The patent estate is weak as a source of market exclusivity but can remain relevant at the manufacturing level.

Composition and formulation patents

The original compound and finished-product patents were filed decades ago. Their ordinary statutory terms have elapsed in the major jurisdictions where cisapride was commercialized. Formulation claims would need to cover a genuinely novel product and would not automatically protect conventional capsules, tablets or suspensions.

Method-of-use patents

Historical indications included gastroesophageal reflux disease and gastrointestinal motility disorders. Broad method-of-use claims for those indications are unlikely to create meaningful present-day exclusivity because of age, prior art and the withdrawal of the reference product.

Manufacturing patents

Manufacturing know-how may have greater practical importance. Relevant areas include:

• Stereochemical and impurity control.
• Hydrate formation and stability.
• Crystallization conditions.
• Particle-size control.
• Analytical methods.
• Long-term storage and packaging.

These assets can raise entry costs, but they are not equivalent to enforceable market exclusivity. A competing supplier may develop an independent process or source the API from another qualified manufacturer.

Are there Paragraph IV challenges or biosimilar risks?

There is no meaningful current Paragraph IV litigation profile for cisapride comparable with active blockbuster drugs. Paragraph IV litigation generally arises when a generic applicant challenges listed patents for an FDA-approved reference product. Cisapride’s U.S. commercial product was withdrawn, and the current market is dominated by compounding rather than an active branded-generic substitution cycle.

There is no biosimilar risk. Cisapride is a small-molecule drug, not a biologic. The relevant competitive risks are:

• New or reactivated generic approval, if legally and commercially feasible.
• Compounded alternatives.
• Substitution by other prokinetic or gastrointestinal medicines.
• Veterinary-specific products.
• API supplier competition.

What litigation affected cisapride?

Cisapride generated substantial litigation and regulatory exposure because of alleged cardiac injuries and deaths associated with Propulsid. The legal risk centered on:

• Failure-to-warn allegations.
• Drug-interaction risks.
• Patient-selection and contraindication issues.
• Adequacy of pharmacovigilance.
• Physician and patient communications.
• Product-liability claims following arrhythmic events.

The litigation exposure contributed to the commercial withdrawal decision, although the primary market event was the safety-driven regulatory and manufacturer action. Current litigation is unlikely to be a significant revenue variable for the API market, but historical liability remains relevant when evaluating acquisition of legacy rights, records or related businesses.

Which companies compete in the cisapride monohydrate market?

The market is fragmented. Janssen no longer operates a conventional U.S. commercial cisapride business. Current participants are more likely to include:

• API manufacturers producing cisapride monohydrate.
• Specialty pharmaceutical distributors.
• Veterinary compounding pharmacies.
• Human compounding pharmacies.
• Veterinary clinics and referral hospitals.
• International suppliers in jurisdictions where the product remains permitted.

The principal competitive advantage is not brand recognition. It is regulatory compliance, dependable API sourcing and the ability to support validated compounded dosage forms.

Named supplier rankings and market shares are not reliably disclosed in public company filings. Most participants do not report cisapride revenue separately, making concentration difficult to measure.

How does cisapride compare with competing gastrointestinal drugs?

Cisapride is commercially disadvantaged against therapies with stronger safety profiles, active approvals and established reimbursement.

Product class	Relative position versus cisapride
Proton-pump inhibitors	Stronger mainstream use for acid-related disease
H2-receptor antagonists	Lower-cost alternatives for selected acid conditions
Metoclopramide	Established prokinetic alternative, with its own neurologic risks
Domperidone	Used in some markets but subject to cardiac restrictions
Prucalopride	More targeted modern prokinetic option for constipation
Lubiprostone and linaclotide	Approved alternatives for constipation-related indications
Veterinary motility therapies	May compete directly in animal patients

Cisapride can retain demand where a prescriber considers its prokinetic effect clinically useful and alternatives unsuitable. That demand is narrow because the safety profile limits broad prescribing.

What generic launch risks exist for cisapride monohydrate?

A large generic launch is unlikely to be the central market scenario. The more probable outcomes are:

Base case

The market remains a low-volume compounding and veterinary niche. API suppliers compete on quality and availability, while finished products remain individualized.

Upside case

A sponsor obtains a viable regulatory pathway for a narrowly defined indication, dosage form or patient population. This could create a small specialty market, but it would require substantial cardiac-safety work and physician adoption.

Downside case

Further restrictions on compounding or supply controls reduce access. Demand would migrate toward alternative prokinetic therapies or other gastrointestinal treatments.

A conventional generic launch would face weak commercial economics. The sponsor would need to overcome safety-related prescribing reluctance, regulatory scrutiny, limited reimbursement and the absence of a broad untreated market.

What is the financial trajectory for cisapride monohydrate?

The financial trajectory is a collapse from branded blockbuster economics to specialty-niche economics.

Financial phase	Revenue profile	Margin profile	Principal risk
Pre-2000 branded period	High-volume prescription sales	Originator-level margins	Cardiac safety and liability
2000-2004 restricted period	Rapid revenue contraction	Lower scale, higher compliance burden	Access restrictions
Current compounding period	Small, fragmented sales	Potentially attractive unit economics, low total revenue	Regulatory and supply disruption
Long-term outlook	Stable-to-declining niche demand	Supplier-dependent	Substitution and tighter oversight

The key distinction is between unit margin and market size. Compounded cisapride can command a higher price per prescription than a mass-market generic, but total revenue remains constrained by low patient numbers, limited indications and regulatory controls.

For investors or licensors, cisapride monohydrate is primarily a niche supply and compounding asset. It is not a credible large-scale branded growth opportunity without a new clinical and regulatory strategy.

What geographic markets remain relevant?

Geographic opportunity is uneven.

• United States: limited to controlled compounding and veterinary use.
• European Union: broad human commercialization has been curtailed by safety concerns; national availability must be assessed separately.
• Canada: historical commercial use ended or was heavily restricted.
• Asia-Pacific and Latin America: availability may vary by country, but regulatory status and commercial demand are not uniform.
• Veterinary markets: potentially more durable than human markets where compounding is permitted.

A supplier must evaluate each country separately because a product can be legally obtainable as an API while the finished dosage form remains unauthorized or unavailable.

What manufacturing and supply barriers affect cisapride monohydrate?

The principal barriers are operational and regulatory:

1. Qualified API sourcing.
2. Control of hydrate form and polymorphic behavior.
3. Stability testing.
4. Impurity and degradation-product monitoring.
5. Documentation for compounding pharmacies.
6. Import controls and customs classification.
7. Batch traceability.
8. Appropriate labeling and handling of a drug with serious cardiac warnings.

The monohydrate designation matters for specification control. A supplier must ensure that the material consistently meets identity, water-content, potency and impurity requirements. Differences in solid form or moisture content can affect weighing, stability and finished-product performance.

Key Takeaways

• Cisapride monohydrate has no material active branded human market in the United States.
• Propulsid was withdrawn from U.S. commercial distribution on March 14, 2000, after serious cardiac safety concerns.
• Current demand is concentrated in human compounding, veterinary compounding and API supply.
• The legacy patent estate does not provide meaningful modern market exclusivity.
• Paragraph IV and biosimilar risks are not significant current drivers.
• Manufacturing quality, supply reliability and regulatory compliance matter more than legacy product patents.
• Revenue potential is niche and fragmented, with no reliable public standalone sales series.
• The most realistic commercial strategy is specialty API or veterinary supply, not a mass-market relaunch.

FAQs

Is cisapride monohydrate the same as Propulsid?

Cisapride monohydrate is the active pharmaceutical ingredient form associated with the former branded product Propulsid. Propulsid was a finished dosage-form product marketed by Janssen.

Can cisapride monohydrate be sold over the counter?

Cisapride is not an appropriate over-the-counter product in the United States. Access is controlled because of serious cardiac risks and is generally limited to regulated prescription or compounding channels.

Does cisapride monohydrate have an active Orange Book listing?

The former Propulsid product is not an active, routinely marketed U.S. reference product. Current compounding activity does not create the same Orange Book framework as an active FDA-approved commercial product.

Is cisapride monohydrate used in animal medicine?

Yes. Compounded cisapride is used in veterinary practice for selected gastrointestinal motility conditions, including constipation and megacolon, subject to applicable prescribing and compounding rules.

Could cisapride monohydrate become a valuable specialty pharmaceutical again?

Only through a new, narrowly defined regulatory and clinical strategy. A relaunch would face substantial cardiac-safety, clinical-development, physician-adoption and reimbursement barriers.

References

1. U.S. Food and Drug Administration. (2000). FDA announces voluntary withdrawal of Propulsid. FDA Drug Safety Communications.

2. U.S. Food and Drug Administration. (2004). Cisapride: limited access program information. FDA.

3. U.S. Food and Drug Administration. (n.d.). Animal drugs, compounded drugs, and the Federal Food, Drug, and Cosmetic Act. FDA Center for Veterinary Medicine.

4. U.S. Food and Drug Administration. (n.d.). Propulsid (cisapride) prescribing information and safety communications. FDA.

5. European Medicines Agency. (2000). Public statement on the withdrawal of cisapride-containing medicinal products. EMA.