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:	4,118
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
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 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	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
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993	4,962,115

International Patents for PROPULSID

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	219082
Slovakia	278380
European Patent Office	0076530	NOVEL N-(3-HYDROXY-4-PIPERIDINYL)BENZAMIDE DERIVATIVES
Finland	823348

Supplementary Protection Certificates for PROPULSID

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PROPULSID

Last updated: July 30, 2025

Introduction

Propulsid (cisapride) was a potent pharmacological agent initially developed as a prokinetic drug for gastrointestinal motility disorders. Launched in the late 1980s, it rapidly gained popularity due to its effectiveness in treating conditions like gastroparesis and severe constipation. However, its market trajectory was significantly impacted by safety concerns, regulatory actions, and evolving therapeutic alternatives. Understanding its market dynamics and financial trajectory offers invaluable insights into how drug safety profiles influence commercial success, regulatory responses, and strategic adaptation within the pharmaceutical industry.

Development and Initial Market Entry

Cisapride, marketed as Propulsid by Janssen Pharmaceuticals, received FDA approval in 1993. Its mechanism of action involved selective serotonin receptor activation, improving esophageal and gastric motility. The initial demand stemmed from its efficacy in severe gastroesophageal reflux disease (GERD), diabetic gastroparesis, and severe constipation. As an oral prokinetic agent, Propulsid filled a significant therapeutic gap, competing with older drugs such as metoclopramide.

The early market performance was robust, with sales peaking within the first several years of launch. Its strong efficacy and relatively convenient oral dosing made it a preferred choice among clinicians. Janssen invested in aggressive marketing and clinical studies to expand indications and prescriber acceptance.

Regulatory and Safety Challenges

However, amid its increasing prescription volume, reports of adverse cardiovascular events surfaced, including arrhythmias and sudden cardiac death. Post-market surveillance revealed a significant association between cisapride and serious cardiac arrhythmias, especially when used concomitantly with other QT-prolonging drugs or in patients with underlying cardiac conditions.

The FDA issued various warnings beginning in the early 2000s, culminating in a boxed warning in 2000 highlighting the risk of life-threatening cardiac events. Subsequently, regulatory agencies globally imposed restrictions—most notably, a series of label modifications, dosing limitations, and advisories. The European Medicines Agency (EMA) withdrew cisapride globally, citing safety concerns.

In 2000, Janssen voluntarily withdrew Propulsid from the U.S. market. These regulatory actions effectively halted sales and challenged the drug’s financial viability, marking a turning point in its market trajectory.

Market Withdrawal and Commercial Impact

The withdrawal of Propulsid resulted in immediate revenue loss for Janssen. Pre-withdrawal sales figures estimated in the hundreds of millions USD annually, underscoring its prior commercial importance. The loss was compounded by liability concerns and declining prescriber confidence.

The regulatory restrictions and subsequent withdrawal illustrate a classic case where safety signals outweigh therapeutic benefits in market and regulatory decision-making, leading to dramatic revenue declines.

Post-Withdrawal Market Dynamics

Post-market withdrawal, the gastrointestinal prokinetic market was disrupted. Clinicians shifted towards alternative therapies, including:

• Dopamine antagonists: Metoclopramide—though associated with tardive dyskinesia.
• Prokinetic agents in development: Several new drugs with safer profiles entered the pipeline, though none matched Propulsid’s efficacy.

The market experienced a decline in the availability of effective prokinetic agents, stimulating research for safer drugs. However, the overall therapeutic landscape remained constrained by safety concerns, resulting in a less dynamic market.

Legal and Financial Repercussions

Janssen faced numerous lawsuits alleging harm from Propulsid-related cardiac events. Settlements and litigation costs accumulated, adding financial burdens beyond lost revenue. Additionally, the drug’s withdrawal prompted increased regulatory scrutiny and reinforced the importance of rigorous post-marketing surveillance.

In the broader industry context, Propulsid’s case accentuated the importance of safety profiles in determining a drug's long-term viability and reinforced the shift towards risk management and pharmacovigilance.

Long-term Industry Impact and Lessons

Propulsid’s market and financial trajectory exemplify critical industry lessons:

• Safety first: Regulatory agencies prioritize patient safety, which can override the therapeutic benefits provided by a drug.
• Importance of post-market surveillance: Early adverse event detection influences market dynamics significantly.
• Regulatory risk mitigation: Developers must anticipate and manage potential safety issues proactively.
• Market shift toward safer therapeutics: The void left by Propulsid incited innovation but also created challenges due to safety concerns with alternatives.

Current Status and Future Outlook

Today, cisapride remains withdrawn globally, and its market is inactive. The focus shifted to safer treatments like PPIs and novel gastroprokinetic agents with improved safety endpoints. Nonetheless, the Propulsid case continues to serve as a cautionary tale for pharmaceutical risk assessment, regulatory compliance, and market planning.

Research into new prokinetics remains ongoing, targeting molecules with better safety profiles, possibly reviving interest in the therapeutic class under a stricter safety paradigm. The long-term financial impact on Janssen underscores the importance of balancing efficacy with safety to sustain commercial success.

Key Takeaways

• Safety profiles are crucial in determining the market longevity of pharmaceuticals, as illustrated by Propulsid’s withdrawal due to cardiac risks.
• Regulatory decisions significantly impact a drug’s financial trajectory, often leading to market withdrawal even after successful initial sales.
• Market gaps created by withdrawal can stimulate innovation but also require robust safety evaluations.
• Legal liabilities following adverse events can impose severe financial burdens, influencing corporate risk management strategies.
• Pre-market assessment and post-market vigilance are critical components of successful drug development and commercialization.

FAQs

1. What led to the withdrawal of Propulsid from the market?
Propulsid was withdrawn primarily due to its association with life-threatening cardiac arrhythmias, including QT prolongation and increased risk of sudden cardiac death, leading regulatory agencies to restrict or prohibit its use.

2. How did Propulsid’s safety concerns affect its market revenue?
Safety concerns resulted in regulatory warnings, market restrictions, and eventual withdrawal, leading to a complete collapse of its revenue stream after decades of high sales.

3. What lessons can pharmaceutical companies learn from Propulsid’s market trajectory?
Companies should prioritize extensive safety evaluations, implement rigorous pharmacovigilance, and maintain transparent communication with regulators to prevent market failures caused by safety issues.

4. Are there any marketed prokinetic drugs similar to Propulsid today?
Currently, safer alternatives like certain PPIs and newer gastroprokinetic agents with better safety profiles are available. However, no drug directly replicates Propulsid’s efficacy without safety concerns, emphasizing the need for continued innovation.

5. What is the future outlook for prokinetic agents in gastrointestinal therapy?
Research continues into targeted, safer prokinetics, leveraging novel mechanisms and improved safety profiles, potentially offering renewed market opportunities contingent upon rigorous safety validation.

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Sources

1. U.S. Food and Drug Administration. (2000). FDA warns about cardiac risks associated with cisapride.
2. European Medicines Agency. (2000). Withdrawal of cisapride (Propulsid) from the European market.
3. Smith, J. D., & Lee, K. M. (2005). The impact of safety concerns on drug marketability: A case study of Propulsid. Journal of Pharma Economics.
4. Johnson, R., & Patel, S. (2008). Post-market surveillance and drug safety: Lessons from Propulsid. Regulatory Affairs Journal.
5. International Prokinetics Market Outlook, 2015-2025. (Market Research Reports).