PROPULSID QUICKSOLV Drug Patent Profile

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

Propulsid Quicksolv is a drug marketed by Janssen Pharma and is included in one NDA.

The generic ingredient in PROPULSID QUICKSOLV 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 QUICKSOLV

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Patent Applications:	6,144
DailyMed Link:	PROPULSID QUICKSOLV at DailyMed

US Patents and Regulatory Information for PROPULSID QUICKSOLV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997		DISCN	No	No

Expired US Patents for PROPULSID QUICKSOLV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997	4,962,115
Janssen Pharma	PROPULSID QUICKSOLV	cisapride monohydrate	TABLET, ORALLY DISINTEGRATING;ORAL	020767-001	Nov 7, 1997	5,648,093

International Patents for PROPULSID QUICKSOLV

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	280009	Deriváty N-(4-piperidinyl)benzamidu a způsob jejich výroby (DERIVATIVES OF N-(4-PIPERIDINYL)BENZAMIDE AND PROCESS FOR PREPARING THEREOF)
Israel	105553	SOLID DOSAGE FORM COMPRISING A POROUS NETWORK OF MATRIX FORMING MATERIAL WHICH DISPERSES RAPIDLY IN WATER
Czech Republic	8206821
Cyprus	1445	NOVEL N-(3-HYDROXY-4-PIPERIDINYL)BENZAMIDE DERIVATIVES

Supplementary Protection Certificates for PROPULSID QUICKSOLV

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 QUICKSOLV

Last updated: July 28, 2025

Introduction

Propulsid Quicksolv, also known by its active ingredient cisapride, was once regarded as a prominent prokinetic agent used predominantly for managing gastrointestinal motility disorders such as gastroesophageal reflux disease (GERD) and diabetic gastroparesis. Launched in the 1990s, Propulsid Quicksolv experienced rapid adoption due to its innovative quick-dissolving formulation, offering rapid onset of relief. However, its market presence was significantly impacted by safety concerns leading to market withdrawal, profoundly influencing the product’s financial and regulatory trajectory. This analysis explores the evolving market dynamics, the factors influencing Propulsid Quicksolv’s financial performance, and future outlook considerations.

Market Overview and Therapeutic Context

The gastrointestinal pharmacotherapy market has historically been characterized by high demand for effective prokinetics. Prior to safety revelations, cisapride (Propulsid) captured a substantial market share owing to its efficacy in enhancing gastrointestinal motility. The introduction of Propulsid Quicksolv aimed to capitalize on patient preference for rapid, oral dissolvable formulations, aligning with evolving consumer expectations for convenience.

The therapeutic landscape has shifted over the past decade, with increased regulatory scrutiny of prokinetics. The emergence of safer alternative drugs such as metoclopramide and newer classes like motilin receptor agonists has diminished cisapride’s market share. Nonetheless, the initial market was sizable, with sales peaking in the late 1990s and early 2000s.

Market Dynamics Influencing Propulsid Quicksolv

Regulatory Developments and Safety Concerns

Cisapride’s recall in 2000 stands as a pivotal moment, precipitated by reports of serious cardiac arrhythmias associated with QT prolongation. The U.S. Food and Drug Administration (FDA) issued a black box warning and ultimately withdrew approval for over-the-counter and prescription use [1]. Similar actions occurred internationally, severely constraining Propulsid’s availability.

This regulatory crackdown drastically reduced its market footprint, causing immediate revenue declines. Pharmacovigilance practices, initially robust but subsequently criticized for delays, marked a turning point influencing future drug development and post-marketing surveillance in the industry.

Market Demand and Pharmaceutical Strategies

Pre-recall, Propulsid Quicksolv captured a niche of consumers valuing rapid relief and ease of administration. The quick-dissolving formulation enhanced patient adherence, especially among pediatric and geriatric populations, representing a unique competitive advantage.

Post-recall, pharmaceutical companies faced strategic shifts. Some pursued reformulation or new delivery mechanisms; others exited the gastrointestinal space altogether. The market consolidated around drugs with better safety profiles, diminishing demand for cisapride-based therapies.

Competitive Landscape Evolution

The therapeutic area has increasingly favored drugs with established safety profiles, like proton pump inhibitors (PPIs) and newer prokinetics with less cardiotoxicity. These developments rendered Propulsid Quicksolv obsolete, replacing its market segment with safer alternatives.

Research and development delays, coupled with safety liabilities, deterred investment in cisapride derivatives. Competitors with better safety data captured larger market shares, altering market shares and diminishing Propulsid Quicksolv’s commercial viability.

Financial Trajectory

Initial Revenue Performance

Prior to its market withdrawal, Propulsid Quicksolv generated substantial revenue, peaking at approximately $1.2 billion globally in 1999. The formulation’s rapid onset and convenience contributed to high prescriptions across North America, Europe, and Asia. The drug’s sales fueled growth for its manufacturer, Janssen Pharmaceuticals, which benefited from associated licensing and distribution collaborations.

Revenue Decline Post-Recall

Following the 2000 regulatory actions, revenues plummeted. Sales halved within months, with subsequent market exit effectively ceasing commercial activity. The abrupt decline resulted in financial losses marked by inventory write-offs, legal liabilities, and termination of marketing efforts.

Legal Liabilities and Compensation

Litigation over adverse cardiac events led to significant legal liabilities. Janssen faced numerous lawsuits, resulting in settlements and compensation costs estimated in the hundreds of millions USD. These liabilities further compounded the decline in global revenues and impacted the financial health of associated entities.

Pipeline/Alternatives and Market Rebound

Post-withdrawal, the pipeline for cisapride derivatives was largely abandoned. The focus shifted to safer prokinetics, reducing R&D investments in cisapride-like molecules. Consequently, the long-term financial trajectory of Propulsid Quicksolv, in terms of direct sales, was terminal.

However, secondary effects include increased investment in pharmacovigilance systems and the development of safer GI agents, influencing the broader market landscape. The financial impact extended beyond the original product to shape strategic decisions in gastrointestinal therapeutics.

Regulatory and Market Outlook

Currently, Propulsid Quicksolv remains withdrawn from the market. However, the landscape is evolving with advances in pharmacogenomics and targeted therapies. No direct revival of cisapride formulations is anticipated due to proven safety concerns. Nonetheless, the case underscores the importance of rigorous safety assessments, which now dominate regulatory and market considerations.

Future prospects lie in the development of novel prokinetics with high efficacy and safety, driven by innovative mechanisms such as selective 5-HT4 receptor agonists and gastroparesis-specific drugs like relamorelin. These developments are reshaping the GI therapy market, but no substantive financial trajectory exists for Propulsid Quicksolv moving forward.

Key Market Insights

• Regulatory actions and safety concerns remain the principal determinants of Propulsid Quicksolv’s decline.
• Market demand shifted rapidly post-recall toward safer alternatives; no rebound anticipated.
• Legal liabilities significantly affected the financial health of the original manufacturer and industry trust.
• Innovation focus has transitioned toward safer, targeted therapies within gastrointestinal pharmacotherapy.
• Investment strategies favor risk-averse models, with regulatory caution serving as a primary screen for development pipelines.

Key Takeaways

• The Propulsid Quicksolv case exemplifies how safety concerns and regulatory responses can rapidly alter a drug’s market trajectory.
• Advanced pharmacovigilance and post-marketing surveillance are critical to mitigate legal liabilities and sustain product viability.
• The shift toward safer pharmacological options diminishes the prospects for re-entry of drugs like cisapride into the mainstream market.
• Future innovations in gastrointestinal therapy emphasize safety profiles, personalized medicine, and targeted delivery, with minimal reliance on previously controversial agents.
• Industry stakeholders should prioritize comprehensive safety assessments, regulatory compliance, and proactive risk management to optimize financial outcomes.

FAQs

1. Why was Propulsid Quicksolv withdrawn from the market?
Propulsid Quicksolv (cisapride) was withdrawn due to serious safety concerns, notably its association with life-threatening cardiac arrhythmias caused by QT prolongation, leading regulatory agencies like the FDA to issue warnings and eventual market removal.

2. Are there any ongoing legal liabilities related to Propulsid Quicksolv?
Yes, Janssen Pharmaceuticals faced numerous lawsuits alleging cardiac injuries from cisapride, resulting in substantial legal settlements and compensation expenses, impacting the company's financial stability during the early 2000s.

3. What are the primary factors influencing the decline of drugs like Propulsid Quicksolv?
The key factors include safety issues, regulatory restrictions, the emergence of safer alternatives, declining efficacy perception, and legal liabilities discouraging ongoing investment.

4. Is there any potential for repurposing cisapride or similar agents in the future?
Currently, due to safety concerns, repurposing cisapride is improbable. Advances in drug design aim to retain efficacy while eliminating cardiotoxicity, but these are experimental and face stringent regulatory hurdles.

5. How has the market for gastrointestinal prokinetic agents evolved after Propulsid's withdrawal?
Post-Propulsid, the market shifted toward safer medications such as PPIs and newer prokinetics like prucalopride, emphasizing safety and targeted mechanisms to meet patient needs while navigating tighter regulatory standards.

References

[1] U.S. Food and Drug Administration. (2000). FDA Drug Safety Communication: FDA limits use of the drug cisapride (Propulsid) to treat specific conditions.