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
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.)
Ireland	904520
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)
Hong Kong	1011279
Japan	3107566
Poland	138475

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 PROPULSID QUICKSOLV

Last updated: February 24, 2026

What is Propulsid QuickSolv?

Propulsid QuickSolv is a formulation of cisapride, originally marketed as Propulsid, used for gastrointestinal motility disorders. The drug was withdrawn from the US market in 2000 due to cardiovascular safety concerns linked to QT prolongation. Quadruple-salt formulations or controlled-release variants aim to mitigate adverse effects and extend the drug's market viability.

Market Landscape and Regulatory Status

Regulatory Actions and Compliance

• The original Propulsid was withdrawn in the US by Johnson & Johnson in 2000 following FDA warnings pertaining to serious cardiac arrhythmias.
• In Europe, cisapride faced regulatory restrictions but remains available in some countries under controlled conditions.
• Current efforts focus on reformulations that can meet safety standards or on alternative delivery systems.

Key Market Players

• Johnson & Johnson (former owner of Propulsid)
• Generic pharmaceutical companies attempting reformulations
• Biotech firms exploring cisapride derivatives

Patent and Exclusivity Status

• Patent protection for Propulsid expired in the early 2000s.
• No active patents currently inhibit reformulation efforts.
• Market entry depends mainly on regulatory approval and safety profile.

Market Demand and Use Cases

Clinical Indications

• Gastroesophageal reflux disease (GERD)
• Gastrointestinal motility disorders
• Off-label uses for postoperative ileus and gastroparesis

Current Market Factors

• Declining use post-withdrawal due to safety concerns
• Emerging demand for safer prokinetic agents
• Shift towards therapies with improved safety profiles

Resurgence Potential

• Reformulated products with improved safety could rekindle interest.
• Regulatory approval hinges on demonstrating risk mitigation.
• No significant off-label market growth expected without new formulations or approvals.

Financial Trajectory and Investment Outlook

Revenue Projections

Scenario	Revenue Potential	Key Factors
Reintroduction with safety measures	Up to $250 million annually in niche markets	Dependent on regulatory approvals and physician acceptance
Continued market stagnation	<$50 million annually due to declining legacy use	Driven by limited formulary availability and safety concerns

Cost Considerations

• Reformulation R&D costs: Estimated at $20–50 million for safety testing and clinical trials.
• Regulatory submission costs: Estimated at $10–30 million, depending on jurisdiction.
• Litigation and liability: Potential for significant costs given historical safety issues.

Investment Risks

• High risk of failure in regulatory reapproval.
• Post-market surveillance may remain stringent.
• Competition from existing prokinetics with improved safety profiles.

Key Financial Drivers

• Success in safety profile improvement
• Regulatory approval timelines
• Physician and patient perception of risk-benefit tradeoffs

Market Entry Barriers and Opportunities

Barriers

• Historical safety concerns with cisapride.
• Regulatory hurdles for reformulated products.
• Limited patent protection, reducing exclusivity incentives.

Opportunities

• Development of targeted delivery systems to reduce cardiotoxicity.
• Partnerships with biotech firms specializing in drug reformulation.
• Expansion into markets with less regulatory stringency.

Conclusion

The future of Propulsid QuickSolv relies heavily on reformulation strategies that address safety issues. Financially, a successful reentry could yield moderate revenues, primarily in niche markets. However, significant barriers remain, including regulatory approval challenges and high development costs.

Key Takeaways

• Propulsid QuickSolv’s market prospects depend on overcoming safety concerns that led to the original drug’s withdrawal.
• No current patents provide exclusivity, increasing competition risks.
• Revenue potential hinges on regulatory outcomes and physician acceptance.
• Cost projections estimate $30–80 million for development and approval phases.
• The market is small with limited growth unless new formulations demonstrate a markedly improved safety profile.

FAQs

Q1: Can Propulsid QuickSolv be legally reintroduced in the US?
A: Reintroduction is unlikely without reformulation demonstrating a comparable safety profile to avoid FDA scrutiny and safety concerns that led to original withdrawal.

Q2: What are the major safety issues associated with cisapride?
A: The primary safety concern is QT prolongation, which can result in serious arrhythmias and sudden cardiac death.

Q3: Are there ongoing clinical trials for modified cisapride formulations?
A: As of 2023, no significant clinical trials are publicly announced for reformulated cisapride products, but research on safer prokinetic drugs is ongoing.

Q4: How does the market for prokinetic agents look currently?
A: The market is dominated by alternative therapies with improved safety profiles, limiting opportunities for cisapride-based products.

Q5: What strategies could mitigate high development costs?
A: Partnerships with biotech firms, leveraging existing clinical data, and focused safety trials may lower costs and accelerate approval.

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References

1. Food and Drug Administration. (2000). FDA Advisory Committee Briefing Document. https://www.fda.gov/ohrms/dockets/ac/00/briefing/3649b1.pdf
2. European Medicines Agency. (2007). Risk of cardiac arrhythmias with cisapride. https://www.ema.europa.eu/en/documents/scientific-guideline/assessment-risk-therapy-appendix-risk-cardiac-arrhythmias-cisapride_en.pdf
3. MarketWatch. (2022). Global gastrointestinal drugs market overview. Retrieved from https://www.marketwatch.com/analysis
4. U.S. Patent and Trademark Office. (2023). Patent expiration data, cisapride-related patents. https://uspto.gov
5. BioPharm Insight. (2023). Pipeline developments for gastrointestinal prokinetic agents.