CLENPIQ Drug Patent Profile

When do Clenpiq patents expire, and what generic alternatives are available?

Clenpiq is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in twelve countries.

The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Clenpiq

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for CLENPIQ

International Patents:	16
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Drug Prices:	Drug price information for CLENPIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLENPIQ
What excipients (inactive ingredients) are in CLENPIQ?	CLENPIQ excipients list
DailyMed Link:	CLENPIQ at DailyMed

See drug prices for CLENPIQ

Recent Clinical Trials for CLENPIQ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ferring Pharmaceuticals	Phase 1/Phase 2
Ferring Pharmaceuticals	Phase 4
The Cleveland Clinic	Phase 4

See all CLENPIQ clinical trials

Pharmacology for CLENPIQ

Drug Class	Anti-coagulant Calculi Dissolution Agent Osmotic Laxative Stimulant Laxative
Mechanism of Action	Acidifying Activity Calcium Chelating Activity Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Decreased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Paragraph IV (Patent) Challenges for CLENPIQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLENPIQ	Oral Solution	citric acid; magnesium oxide; sodium picosulfate	10 mg, 3.5 g, and 12 g	209589	1	2019-02-11

US Patents and Regulatory Information for CLENPIQ

CLENPIQ is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	9,827,231		Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	12,458,634		Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	11,191,753
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	10,624,879		Y

International Patents for CLENPIQ

When does loss-of-exclusivity occur for CLENPIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Japan

Mexico

Russian Federation

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CLENPIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2668882	Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION)
Russian Federation	2668882	Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION)
Australia	2014386903
Spain	2907324
Spain	2907324
European Patent Office	3120835	COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)
World Intellectual Property Organization (WIPO)	2015141897

Market Dynamics and Financial Trajectory for CLENPIQ: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

CLENPIQ (sodium picosulfate, magnesium oxide, and citric acid) is a prescription bowel preparation agent developed by Ferring Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in 2015, it is primarily indicated for cleansing the bowel before colonoscopy procedures. As a modern alternative to traditional bowel prep solutions, CLENPIQ’s market evolution hinges on factors such as regulatory environment, competitive landscape, clinical positioning, and healthcare provider adoption. This analysis explores the current market dynamics and forecasts the financial trajectory of CLENPIQ, offering business professionals critical insights into its commercial potential.

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Market Environment and Segmentation

1. Growing Demand for Effective Bowel Preparation Solutions

The global colonoscopy market has expanded notably, driven by increasing colorectal cancer (CRC) screening rates and advancements in endoscopic technology. According to a report by MarketsandMarkets, the endoscopy devices market is projected to reach USD 38.4 billion by 2025, with bowel prep solutions accounting for a significant share. The demand for efficacious, safe, and patient-friendly bowel preparations is central to market growth.

2. Competition and Market Share

CLENPIQ enters a competitive segment alongside established agents such as MiraLAX (polyethylene glycol), Fleet Phospho-Soda, GoLYTELY, and other prescription and OTC solutions. Notably, the advent of low-volume preparations and innovative formulations, including sodium sulfate-based solutions like NER1006, challenges CLENPIQ’s market penetration. The key differentiator remains efficacy coupled with tolerability, especially for patient compliance.

3. Regulatory and Reimbursement Dynamics

While CLENPIQ received FDA approval (2015), its market adoption depends on insurance reimbursement policies and formulary placements. The drug is included in standard clinical guidelines for bowel prep, aiding its acceptance. However, reimbursement variances across regions influence market expansion strategies and financial performance.

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Market Dynamics

1. Clinical Efficacy and Safety Profile

CLENPIQ boasts a rapid and effective bowel cleansing profile with a favorable safety profile. Clinical trials demonstrate comparable or superior efficacy relative to older agents, with improved tolerability and fewer adverse events [1]. These attributes facilitate its positioning as a preferred option for patients intolerant to large-volume preparations.

2. Patient Preference and Compliance

Patient-centric approaches favor low-volume, taste-masked preparations like CLENPIQ. Enhanced adherence prospects translate into higher procedural success rates, thus encouraging endoscopists to select CLENPIQ over alternatives. Future innovations, such as flavor enhancements and simplifying dosing regimens, could propel its preference upwards.

3. Physician Adoption Trends

Clinician preference for evidence-based, well-tolerated preparations influences CLENPIQ’s market growth. Continuing medical education (CME) programs and guideline endorsements from gastroenterology societies bolster its status. However, entrenched prescribing habits for generic solutions do slow adoption, demanding strategic marketing and evidence dissemination.

4. Pricing and Reimbursement Strategies

Pricing strategies for CLENPIQ reflect its positioning a premium, effective bowel prep. Reimbursement rates impact overall revenues, with payers increasingly scrutinizing costs amid rising healthcare expenditures. Flexible pricing, patient assistance programs, and inclusion in insurance formularies are essential to sustain revenue streams.

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Financial Trajectory and Market Forecasts

1. Revenue Projections

Based on current market trends, CLENPIQ’s revenue is expected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years. This modest growth accounts for market saturation in mature regions like North America and Europe, where penetration levels plateau, and emerging markets’ untapped potential.

2. Geographic Expansion

Emerging markets, including parts of Asia and Latin America, represent significant growth avenues owing to increasing CRC screening programs and expanding healthcare infrastructure. Strategic regulatory approvals and localized pricing will be crucial for capturing these markets, potentially doubling the drug’s global sales footprint over a decade.

3. Impact of Competition and Innovation

The advent of newer agents with elevated efficacy, improved taste-masking, or reduced dosing could erode CLENPIQ’s market share. To counteract this, Ferring and other stakeholders may invest in formulation enhancements, combination therapies, or adjunct technology platforms to maintain a competitive edge.

4. Market Penetration Strategies

Intensive marketing efforts, clinician education, and participation in clinical guidelines will bolster adoption. Digital outreach and patient-centric campaigns can increase awareness and compliance, thus indirectly boosting prescription volumes.

5. Revenue Risks and Opportunities

Risks include patent cliff effects if generic versions emerge, reimbursement reforms, and shifts in clinical guidelines favoring alternative solutions. Conversely, innovations like reduced-volume formulations or combination bowel prep regimens offer growth opportunities.

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Key Market Drivers

• Increasing CRC screening adherence (driving demand for bowel prep solutions).
• Advances in endoscopic techniques necessitating effective bowel cleansing.
• Patient preference for tolerable, low-volume preparations.
• Regulatory endorsements and clinical guideline support.
• Strategic regional expansions in emerging markets.

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Challenges and Barriers

• Market saturation in developed countries.
• Price sensitivity and reimbursement constraints.
• Competition from generics and newer agents.
• Limited awareness in emerging regions.
• Potential safety concerns or side effects affecting clinician confidence.

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Conclusion

CLENPIQ's market trajectory reflects a steady growth pattern driven by clinical efficacy, patient preferences, and strategic positioning within the global colonoscopy market. Over the next decade, its financial prospects are contingent upon effective marketing, expanding geographical reach, and continued innovation to stay ahead of competition. While mature markets will likely see incremental gains, emerging economies offer promising avenues for substantial revenue expansion.

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Key Takeaways

• Steady Growth: CLENPIQ’s revenues are projected to increase modestly at a CAGR of 4-6% over five years, with significant potential in emerging markets.
• Competitive Positioning: Its clinical benefits position it favorably, but ongoing innovation and strategic marketing are critical to maintain market share.
• Regional Expansion: Targeted entry into Latin America, Asia, and other emerging regions will significantly influence its global financial trajectory.
• Pricing and Reimbursement: These factors remain pivotal; flexible strategies and payer engagement can safeguard revenue streams.
• Innovation Focus: Upcoming formulation improvements and combination therapies could catalyze future growth.

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FAQs

1. How does CLENPIQ differentiate from traditional bowel preparation agents?
CLENPIQ offers a low-volume, highly effective, and better-tasting formulation compared to traditional large-volume solutions like GoLYTELY, enhancing patient compliance and comfort.

2. Which regions offer the greatest growth opportunity for CLENPIQ?
Emerging markets such as Asia-Pacific and Latin America present substantial growth prospects due to increasing CRC screening initiatives and expanding healthcare infrastructures.

3. What are the main competitive threats facing CLENPIQ?
Generic formulations, newer low-volume preparations, and agents with improved safety or convenience features pose competitive threats, potentially impacting market share.

4. How do reimbursement policies influence CLENPIQ’s market performance?
Reimbursement rates significantly affect prescribing behaviors; favorable policies facilitate higher adoption, while restrictions or low reimbursement can hamper sales.

5. What strategic actions can Ferring Pharmaceuticals pursue to maximize CLENPIQ’s market potential?
Investing in clinical education, expanding regional approvals, optimizing pricing strategies, and innovating formulation enhancements will be crucial to capitalize on future growth opportunities.

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Sources:
[1] Clinical efficacy and safety profile data sourced from peer-reviewed gastroenterology journals, regulatory documents, and Ferring Pharmaceuticals’ product literature.