PROPULSID Drug Patent Profile

Which patents cover Propulsid, and what generic alternatives are available?

Propulsid is a drug marketed by Janssen Pharms and Janssen Pharma and is included in three NDAs.

The generic ingredient in PROPULSID is cisapride monohydrate. There are two drug master file entries for this compound. Additional details are available on the cisapride monohydrate profile page.

Summary for PROPULSID

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4,324
DailyMed Link:	PROPULSID at DailyMed

Recent Clinical Trials for PROPULSID

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

Sponsor	Phase
Temple University	N/A
American College of Gastroenterology	N/A

See all PROPULSID clinical trials

US Patents and Regulatory Information for PROPULSID

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
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	020210-001	Jul 29, 1993		DISCN	No	No

Expired US Patents for PROPULSID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993
Janssen Pharms	PROPULSID	cisapride monohydrate	SUSPENSION;ORAL	020398-001	Sep 15, 1995
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993

International Patents for PROPULSID

See the table below for patents covering PROPULSID around the world.

Country	Patent Number	Title	Estimated Expiration
Latvia	5044	N-(3-hidroksi-4-piperidinil-)benzamida atvasinajumu vai to skabju-aditivo salu iegusanas metode
Czech Republic	8206821
Bulgaria	41820	METHOD FOR PREPARING N- (3- HYDROXY- 4- PIPERIDINYL) BENZAMIDE DERIVATIVES

Supplementary Protection Certificates for PROPULSID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0076530	SPC/GB93/037	United Kingdom

PROPULSID Market Analysis and Financial Projection

Last updated: April 25, 2026

PROPULSID (cisapride): Market dynamics and financial trajectory

PROPULSID (cisapride) is a branded prescription drug that historically competed in the gastroenterology segment for gastric motility and reflux-related indications. Its commercial trajectory is dominated by safety-driven regulatory actions, payer disruption, and persistent substitution by alternative prokinetics and antireflux therapies. The result is a steep long-run contraction from its launch-era growth and a transition from an active market to a heavily restricted, low-volume status in many geographies.

What was PROPULSID’s market role and how did the category evolve?

PROPULSID’s core positioning was as a prokinetic for GI motility disorders. In practice, it competed with:

• Proton pump inhibitors (PPIs) for acid suppression and symptom control
• H2 blockers as lower-potency acid control
• Other prokinetics and antiemetics that did not face the same torsades de pointes and QT prolongation restrictions

Over time, the GI market shifted toward acid-first treatment algorithms (especially PPIs) and toward prokinetic options with clearer benefit-risk profiles or more permissive regulatory status. As prescribing became more guideline-driven, demand for a restricted prokinetic narrowed even where cisapride remained nominally available.

How did safety and regulatory actions reshape demand?

Cisapride faced strong safety scrutiny tied to QT prolongation and torsades de pointes risk, especially when co-administered with drugs that inhibit hepatic metabolism (notably CYP3A4 inhibitors) and in patients with certain vulnerability profiles. The regulatory tightening translated into:

• Patient access restrictions
• Prescriber hesitation and reduced routine use
• Payer and formulary volatility
• A shrinkage of the eligible treated population versus the drug’s earlier label breadth

The FDA’s most consequential action for commercial trajectory was withdrawal of broader market availability in the United States. The FDA also documents that cisapride use became highly constrained and is no longer marketed in the US for routine prescribing under the original product framework. This marked a structural demand break rather than a gradual decline. (See FDA citations [1] and [2].)

What happened to sales after regulatory tightening?

Cisapride’s financial trajectory is best understood as a post-regulatory “step down” followed by prolonged erosion:

1. Pre-restriction era: Growth aligned with GI prokinetic uptake and symptom demand.
2. Restriction era: Safety signals drove rapid utilization drop due to prescribing limits and access friction.
3. Post-withdrawal era: Sales moved toward residual demand (special access, limited geographies, or legacy inventory periods), with most market volume structurally lost to substitutes.

Public sources on historical revenues are fragmented by geography and time, and the available FDA material concentrates on risk and access rather than company-level quarterly financials. Accordingly, the market narrative is anchored to regulatory and access milestones rather than an uninterrupted series of revenue figures. (FDA record is the primary proof point [1]-[3].)

Where did PROPULSID still trade and how did geography matter?

Geographic outcomes diverged because regulatory frameworks differ in speed and strictness. In many markets outside the US, cisapride remained under tighter conditions for longer, but its competitive position weakened as prescribers shifted to alternatives and regulators maintained or expanded warnings.

Key cross-market dynamic: even where cisapride continued to be supplied, access narrowing reduced addressable demand relative to the pre-safety era. This is the principal economic mechanism behind the brand’s long-run financial contraction: fewer eligible prescriptions and more conservative clinical pathways.

What does the competitive set imply for financial margins and volume?

A prokinetic brand with constrained prescribing typically faces:

• Lower volume from reduced patient eligibility
• Higher commercial friction (prior approvals, special access, restricted dispensing rules)
• Pricing pressure relative to alternatives with broader formulary coverage

Even without full public revenue time series here, the category economics are consistent with the observed regulatory arc:

• When the label narrows, volume declines faster than unit economics can be offset by higher pricing.
• Substitution by PPIs and broader-coverage antiemetics/prokinetics shifts volume away from the constrained brand.

How did payer and formulary behavior likely change?

Safety-related restrictions typically propagate into payer policies:

• Coverage becomes more restrictive or requires documentation of risk criteria
• Step therapy increases as acid-suppression and guideline-standard regimens become prerequisite
• Formularies de-list or limit nonpreferred prokinetics once safer options are available without comparable restrictions

For PROPULSID, the safety signal and subsequent regulatory actions created a payer environment in which “routine prokinetic choice” shifted away from cisapride. That formulary shift compounds the demand shock beyond prescriber perception alone.

What is the investment-grade view: why the trajectory was hard to reverse?

Cisapride’s market fate reflects a product-level constraint: a safety liability profile that is difficult to manage purely through education after wide adoption. Once torsades risk and QT prolongation become central regulatory topics, the limiting factor becomes not just brand awareness but risk controls and eligibility rules across clinicians, pharmacies, and payers. That tends to lock in a durable volume decline.

The FDA materials describe regulatory concern around QT prolongation and significant drug interaction risks that drove restrictive action and ultimately a cessation of routine US availability. That regulatory end state is difficult to overcome by marketing alone. (FDA record [1]-[3].)

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Timeline of key market-determining events

When did regulators alter availability?

• 2000s safety scrutiny period: FDA issued or supported safety communications tied to QT prolongation and torsades risk (context for restrictions) (FDA citations [1]-[3]).
• FDA withdrawal of broader US availability framework: The drug is no longer marketed in the US for routine prescribing; access is constrained or ended depending on product status. (FDA record [2].)

(These citations document the regulatory stance that drove the commercial break.)

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Financial trajectory: what the pattern implies in plain market terms

Volume

• Sharp reduction after restriction milestones
• Persistent low-volume profile thereafter due to substitution and access constraints

Price

• Short-term price support is possible during transition periods but typically erodes as:
  • formulary restrictions harden
  • competitors gain share via guideline-driven standardization

Operating economics

• Fixed costs (safety monitoring, compliance, commercial organization) remain, while sales volume falls
• Reduced scale weakens the brand’s ability to fund ongoing risk mitigation and competitive promotion

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Key takeaways

• PROPULSID’s commercial arc is dominated by safety-driven regulatory tightening tied to QT prolongation and torsades risk, which structurally reduced eligible patient demand. (FDA record [1]-[3].)
• The market shifted away from cisapride as acid-suppression-first pathways and safer or broader-coverage options took share, locking in long-run volume erosion.
• The resulting financial trajectory is a post-regulatory step-down followed by durable contraction rather than a recoverable decline.

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FAQs

1) Was PROPULSID’s decline primarily clinical or competitive?

It was primarily regulatory and clinical, with competitive substitution amplifying the demand shock once access tightened.

2) Did PROPULSID face major drug interaction constraints?

Yes. The FDA record centers torsades risk in the context of QT prolongation and interaction-related vulnerability, which drove restrictive access and prescribing controls. [1]-[3]

3) Why could the brand not regain scale after restrictions?

Because restrictions change the addressable population and increase payer and dispensing friction, while GI treatment pathways increasingly favored competing regimens.

4) Are historical sales figures publicly coherent across all geographies?

Not in a single, uninterrupted dataset suitable for a unified financial trajectory without stitching multiple sources. The FDA record provides the definitive market-breaking milestones, but not a complete sales time series in one place. [1]-[3]

5) What does the PROPULSID case imply for other prokinetics?

In this class, risk profile and regulatory latitude can determine commercial survivability more than differentiation or prior brand equity.

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References (APA)

[1] U.S. Food and Drug Administration. (2000). Cisapride (Propulsid) safety communications and QT prolongation risk information (FDA resources). U.S. FDA. https://www.fda.gov

[2] U.S. Food and Drug Administration. (n.d.). Drug withdrawals and current marketed status references for cisapride/Propulsid. U.S. FDA. https://www.fda.gov

[3] U.S. Food and Drug Administration. (n.d.). Cisapride (Propulsid) information on safety and restricted use related to QT prolongation and drug interactions. U.S. FDA. https://www.fda.gov