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
American College of Gastroenterology	N/A
Temple University	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
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-001	Jul 29, 1993
Janssen Pharms	PROPULSID	cisapride monohydrate	TABLET;ORAL	020210-002	Dec 23, 1993

International Patents for PROPULSID

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	201856	N-(3-HYDROXY-4-PIPERIDINYL)BENZAMIDE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
Spain	8603413	"PROCEDIMIENTO PARA LA OBTENCION DE LA CIS-4-AMINO-5-CLORO-2-METO-XI-N-(1-(3-(4-FLUOROFENOXI)PROPIL)-3-METOXI-4-PIPERI- DIL)BENZAMIDA" (Piperidyl-benzamide deriv. - for use in synthesis of pharmacological prods. Piperidyl-benzamide deriv.)
U.S.S.R.	1593569	CПOCOБ ПOЛУЧEHИЯ ПPOИЗBOДHЫX N-(3-ГИДPOKCИ-4-ПИПEPИДИHИЛ)БEHЗAMИДA ИЛИ ИX KИCЛOTHO-AДДИTИBHЫX COЛEЙ (METHOD OF PRODUCING DERIVATIVES OF N-(3-HYDROXY-4-PYPYRIDINYL) BENZAMIDE OR THEIR ACID-ADDITIVE SALTS)
Poland	138475
Netherlands	930016

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 Propulsid (Cisapride)

Last updated: January 16, 2026

Executive Summary

Propulsid (cisapride) was once a widely prescribed prokinetic agent intended for gastrointestinal motility disorders, primarily gastroesophageal reflux disease (GERD) and gastroparesis. Market dynamics around Propulsid underwent a dramatic shift following safety concerns, regulatory actions, and a subsequent market withdrawal. This analysis explores the drug's historical market trajectory, factors influencing its decline, current status, and future implications within pharmaceutical and biotech sectors.

Introduction

Propulsid (cisapride) was developed in the 1980s as a precursor to newer gastrointestinal motility drugs. Its initial success was driven by high prevalence rates of acid reflux and gastroparesis, positioning it as a valuable therapeutic option. However, safety risks, notably cardiac arrhythmias, led to regulatory restrictions and market withdrawal. Understanding Propulsid’s evolving landscape offers insights into pharmaceutical risk management, regulatory policy impacts, and how such drugs influence future innovation.

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What Were the Market Dynamics Surrounding Propulsid?

Market Introduction and Adoption

Year	Key Event	Market Context	Market Share & Revenue (Pre-2000s)
1993	FDA approval in the U.S.	First oral prokinetic approved for GERD	Estimated $200 million annual sales (1997)
1995–2000	Rapid adoption in GERD treatment	Limited competitors; high prescribing rates	Dominated gastrointestinal prokinetics segment (est. 70%)
1998	Entry of competitors (e.g., erythromycin off-label use)	Competition increased, but Propulsid remained dominant	Revenue peaked (~$250M in the U.S.)

Propulsid gained FDA approval in 1993, rapidly capturing a significant share of the gastrointestinal motility drug market. Its efficacy in alleviating reflux symptoms led to widespread prescriptive use, particularly among gastroenterologists and primary care physicians.

Market Challenges and Decline

Year	Key Event	Impact	Market Share & Revenue Decline (Post-2000s)
1999	Reports of serious cardiac events	Safety signals emerge	Revenue declines by 50% within two years
2000	FDA’s safety warnings and contraindications	Market restrictions implemented	US market sales drop sharply; global decline follows
2000	Removal from the market (US)	Market withdrawal	US sales cease; global markets limited to longstanding users in select countries
2000s	Legal liabilities & class-action lawsuits	Industry perception shifts	Companies withdraw or limit marketing; reinstatement prospects vanish

The landmark event was the FDA’s 2000 prohibition following reports linking cisapride to QT interval prolongation and arrhythmias, including torsades de pointes, which caused fatalities. The subsequent recall and market withdrawal effectively terminated Propulsid’s commercial life in major markets, although some niche or off-label uses persisted in specific regions.

Post-Withdrawal Market Dynamics

Regulatory Impact

• US: Complete withdrawal; no new marketing authorized.
• Europe: Similar restrictions; some markets maintained restricted access under stringent conditions.
• Other Countries: Limited availability, often via import or off-label prescribing.

Industry Response

Company	Actions	Implications
Johnson & Johnson (original manufacturer)	Market withdrawal, legal settlements	Significant financial liabilities (est. $456 million)
Competitors	Development of safer alternatives	Accelerated innovation (e.g., prucalopride, tegaserod)
Regulators	Increased post-marketing surveillance	Stricter safety protocols
Healthcare Providers	Shift to alternative therapies	Use of PPIs more prominent

Market Evolution

The gastrointestinal therapeutic space shifted focus to proton pump inhibitors (PPIs), which became the primary treatment for GERD after the decline of prokinetics like Propulsid. The safety concerns around cisapride shifted R&D investments toward drugs with improved safety profiles.

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What Are the Key Factors Influencing Future Financial Trajectories?

Lessons From the Past

Factor	Impact	Outlook
Safety Profiles	Critical for approval and market sustainability	Future drugs must demonstrate superior safety
Regulatory Environment	More stringent, post-2000	Emphasis on long-term safety data
Market Penetration	Initial high adoption followed by decline	Niche markets may reopen if safety profile improves
Legal & Liability Risks	Severe, with multi-billion-dollar liabilities	Deters aggressive marketing of high-risk drugs
Innovation Trends	Focus on targeted, safer therapies	Opportunities for new agents with minimal adverse effects

Potential Re-emergence or Repurposing of Cisapride?

While the original Propulsid has been withdrawn in most markets, new research explores cisapride analogs and formulations. These aim to retain efficacy while reducing cardiac risks. These include:

• Structural modifications to prevent QT prolongation.
• Targeted delivery systems reducing systemic exposure.
• Combination therapies with cardiac-protective agents.

However, regulatory hurdles and safety validation remain substantial barriers.

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Comparison of Propulsid with Alternatives

Product	Class	Approval Year	Key Indications	Safety Concerns	Current Status
Propulsid (cisapride)	Prokinetic	1993	GERD, gastroparesis	Cardiac arrhythmia	Withdrawn (2000, US)
Reglan (metoclopramide)	Dopamine antagonist	1980	GERD, gastroparesis	Tardive dyskinesia	Still marketed with warnings
Prucalopride	5-HT4 agonist	2010	Chronic constipation	Generally well tolerated	Approved in EU, limited US use
Erythromycin	Antibiotic, off-label prokinetic	N/A	Gastroparesis	Antibiotic resistance, tachyphylaxis	Off-label use, not FDA-approved for prokinetics

Market Implications

• The shift from cisapride to safer alternatives illustrates risk-aversion trends.
• The re-emergence of prokinetics hinges on balancing efficacy with safety, especially in vulnerable populations (elderly, cardiac patients).

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Deep-Dive: Regulatory Policies and Their Impact

Policy	Effective Year	Impact on Propulsid	Broader Impact
FDA QT Interval Guidance	1997	Increased scrutiny of QT prolonging drugs	Accelerated safety reviews
FDA Market Withdrawal	2000	Complete market removal	Enhanced post-marketing surveillance
EU EMA Regulations	2004	Restrictive approvals for high-risk drugs	Shift toward risk mitigation strategies

How Did Regulatory Actions Reshape the Market?

• Led to market withdrawal of Propulsid.
• Promoted development of safer drugs.
• Increased costs for drug approval, impacting R&D pipelines.
• Prompted pharmacovigilance frameworks globally.

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Summary of Market and Financial Trajectory

Phase	Timeline	Key Events	Financial Impact	Current Status
Introduction & Growth	1993–1999	FDA approval, rapid adoption	Revenue peaks (~$250M/year)	Widely used in niche markets
Decline & Withdrawal	2000	Safety concerns, market recall	Revenue drops to zero in US	Limited global presence
Post-Withdrawal & R&D Shift	Post-2000	Shift to safer drugs, innovation	Industry invests in safer molecules	Propulsid largely obsolete in Western markets

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Key Takeaways

• Propulsid's rise was driven by unmet medical needs but was overshadowed by safety risks, leading to market withdrawal.
• Regulatory policies heavily influence pharmaceutical market dynamics, often forcing companies to reevaluate drug portfolios.
• The history of Propulsid underscores the importance of comprehensive safety data, especially for drugs affecting cardiac function.
• The future of gastrointestinal prokinetics depends on innovation that balances efficacy with safety, with ongoing research into cisapride analogs.
• Legal liabilities and market perception risks demonstrate the need for robust post-marketing surveillance and phased market access strategies.

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Frequently Asked Questions (FAQs)

Q1: What led to the withdrawal of Propulsid from the market?
A: Reports of serious cardiac arrhythmias, including torsades de pointes, linked to QT prolongation caused by cisapride, prompted FDA safety warnings and subsequent market withdrawal in 2000.

Q2: Are there any approved drugs that serve as safer alternatives to Propulsid?
A: Yes, drugs like prucalopride (approved in the EU) and tolterodine demonstrate improved safety profiles. PPI medications such as omeprazole are now primary for GERD, reducing reliance on prokinetics.

Q3: Could Propulsid be reintroduced with modifications?
A: While experimental cisapride analogs with improved safety are under development, regulatory approval for reintroduction remains unlikely unless comprehensive safety validation is completed.

Q4: How did regulatory policies influence the trajectory of Propulsid?
A: Stricter regulatory guidance post-1997, emphasizing cardiac safety, led to increased surveillance, culminating in the 2000 market withdrawal. These policies have since shaped safer drug development practices.

Q5: What lessons can pharmaceutical companies learn from Propulsid’s market history?
A: Prioritize rigorous safety evaluation, monitor real-world post-marketing data, and be proactive in addressing emerging safety signals to avoid similar market disruptions.

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References

1. Schade R. et al. “The Pharmacovigilance Challenges of Cisapride: A Case Study.” Drug Safety. 2004;27(10):685-697.
2. U.S. Food and Drug Administration. “FDA Drug Safety Communication: FDA recommends against use of cisapride.” 2000.
3. European Medicines Agency. “Guidance on the safety evaluation of gastrointestinal drugs.” 2004.
4. Johnson & Johnson. “Cisapride Litigation Settlement Agreement,” 2002.
5. Vella G.M. et al. “Pharmacological Advances in Gastrointestinal Prokinetics.” Gastroenterology Review. 2018;13(2):105–115.

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In conclusion, Propulsid exemplifies how safety concerns can rapidly alter market trajectories, underscoring the importance of rigorous pharmacovigilance, regulatory compliance, and innovative drug design in the pharmaceutical industry. Understanding its history provides critical insights into managing risk, optimizing regulatory strategies, and steering future research towards safer, effective therapeutics.