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:	17
Patent Applications:	146
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
European Patent Office	0076530	NOVEL N-(3-HYDROXY-4-PIPERIDINYL)BENZAMIDE DERIVATIVES
Ireland	904520
Spain	2131049
Canada	2046310	PREPARATION D'UN PRODUIT PHARMACEUTIQUE ET AUTRES SYSTEMES MATRICIELS PAR DISSOLUTION EN PHASE SOLIDE (PREPARATION OF PHARMACEUTICAL AND OTHER MATRIX SYSTEMS BY SOLID-STATE DISSOLUTION)

Supplementary Protection Certificates for PROPULSID QUICKSOLV

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

PROPULSID QUICKSOLV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Propulsid Quicksolv

Introduction

Propulsid Quicksolv, the fast-dissolving formulation of the prokinetic agent cisapride, was once a significant player in the gastrointestinal (GI) drug market. However, its rise and fall offer valuable insights into market dynamics, regulatory impacts, and financial trajectories.

Development and Initial Success

Cisapride, the active ingredient in Propulsid, was developed based on its serotonergic properties, which showed promise in treating various motility disorders. Clinical trials and initial market reception were positive, with cisapride becoming a preferred treatment for GI motility issues due to its efficacy and relatively comfortable side-effect profile[3].

Market Penetration and User Base

Propulsid Quicksolv, with its fast-dissolving technology, was particularly appealing due to its ease of administration and rapid disintegration, making it suitable for patients who had difficulty swallowing conventional tablets. This formulation was part of a broader trend in pharmaceuticals towards more patient-friendly drug delivery systems[4].

Regulatory Challenges and Safety Concerns

The success of Propulsid Quicksolv was short-lived due to emerging safety concerns. Reports of serious cardiac events associated with cisapride therapy led to a significant shift in its market dynamics. Regulatory bodies, including the FDA, began to scrutinize the drug closely, and eventually, the manufacturer announced its intent to cease production and withdraw the drug from the market[1][3].

Impact of Market Withdrawal

The withdrawal of cisapride had a direct impact on its utilization and the broader GI drug market. A study analyzing prescription data showed that the use of cisapride decreased precipitously even before the formal withdrawal, indicating a rapid loss of market confidence. This decline led to an increase in the use of other GI agents, particularly metoclopramide, although this increase was not proportional to the decline in cisapride use[1].

Financial Implications

The financial trajectory of Propulsid Quicksolv was severely impacted by its withdrawal. The drug's revenue plummeted as it was removed from the market, and this had a ripple effect on the overall financial performance of the company. While the total GI expenditures within the affected patient cohort declined, this change had little impact on the overall program-wide costs for GI drugs, suggesting that other medications quickly filled the gap left by cisapride[1].

Shift in Market Share

The withdrawal of Propulsid Quicksolv led to a redistribution of market share among other GI agents. Metoclopramide, in particular, saw an increase in usage, although it has a more serious adverse effect profile compared to cisapride. This shift highlights the dynamic nature of the pharmaceutical market, where changes in one product can significantly impact the usage and market share of others[1].

Lessons Learned

The story of Propulsid Quicksolv offers several lessons for the pharmaceutical industry. It underscores the importance of rigorous safety monitoring and the need for continuous evaluation of a drug's risk-benefit profile. The rapid rise and fall of cisapride also highlight the critical role of regulatory bodies in ensuring drug safety and the potential for significant market and financial impacts when safety concerns arise[3].

Impact on Patient Care

The withdrawal of Propulsid Quicksolv had direct implications for patient care. Patients who were dependent on cisapride for their GI motility issues had to be transitioned to other medications, which could have different efficacy and safety profiles. This transition required careful management by healthcare providers to minimize adverse effects and ensure continued effective treatment[1].

Technological Innovations

Despite the withdrawal of Propulsid Quicksolv, the technology behind its fast-dissolving formulation remains relevant. Fast-dissolving drug delivery systems continue to be developed and used in various other medications, offering benefits such as improved patient compliance and ease of administration[4].

Financial Recovery and Diversification

Companies affected by the withdrawal of a major product like Propulsid Quicksolv often need to diversify their product portfolios to recover financially. This can involve investing in research and development to launch new products, as seen in the case of companies like Pfizer, which have successfully navigated similar challenges by advancing their pipelines and launching new products and indications[2].

Key Takeaways

• Regulatory Impact: Safety concerns and regulatory actions can significantly impact a drug's market dynamics and financial trajectory.
• Market Adaptation: The pharmaceutical market is highly dynamic, with changes in one product affecting the usage and market share of others.
• Patient Care: Drug withdrawals require careful management to ensure continued effective treatment for patients.
• Technological Relevance: Innovations in drug delivery systems, such as fast-dissolving formulations, continue to be valuable despite the withdrawal of specific products.
• Financial Diversification: Companies must diversify their product portfolios to recover from the financial impacts of a major product withdrawal.

FAQs

What was the primary reason for the withdrawal of Propulsid Quicksolv from the market?

The primary reason for the withdrawal of Propulsid Quicksolv was the emergence of serious cardiac events associated with cisapride therapy.

How did the withdrawal of Propulsid Quicksolv affect the use of other GI agents?

The withdrawal led to an increase in the use of other GI agents, particularly metoclopramide, although this increase was not proportional to the decline in cisapride use.

What were the financial implications of the withdrawal of Propulsid Quicksolv?

The withdrawal led to a significant decline in revenue from the drug, but it had little impact on overall program-wide costs for GI drugs.

What lessons can be learned from the story of Propulsid Quicksolv?

The story highlights the importance of rigorous safety monitoring, continuous evaluation of a drug's risk-benefit profile, and the critical role of regulatory bodies in ensuring drug safety.

How do companies recover financially from the withdrawal of a major product like Propulsid Quicksolv?

Companies often recover by diversifying their product portfolios, investing in research and development, and launching new products and indications.

Sources

1. Changes in related drug class utilization after market withdrawal of cisapride (Propulsid) - PubMed
2. Pfizer's Second Quarter: Solid Financial Performance and Several Pipeline Advances - Pfizer Insights
3. Cisapride: what can we learn from the rise and fall of a prokinetic? - PubMed
4. A Recent Approach on Fast Dissolving Tablets - Research Journal of Pharmaceutical, Biological and Chemical Sciences