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	2016138577
Mexico	366499	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
Russian Federation	2016138577	Жидкая фармцевтическая композиция
Russian Federation	2668882
Mexico	2016011938	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)

Market Dynamics and Financial Trajectory for CLENPIQ

Last updated: December 28, 2025

Executive Summary

CLENPIQ, a prescription bowel preparation drug formulated by Ferring Pharmaceuticals, is utilized primarily for colonoscopy preparation. Its market trajectory is influenced by regulations, technological advances, competitive landscape, and healthcare infrastructure shifts. This report provides a comprehensive analysis of CLENPIQ’s current market position, growth drivers, challenges, and future financial outlook. It emphasizes key factors shaping the drug’s commercial success, supported by recent data, policy impacts, and competitive dynamics.

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What is CLENPIQ and How Does It Differ?

Attribute	Details
Active Ingredients	Sodium picosulfate, magnesium oxide, and citrate
Indication	Bowel cleansing prior to colonoscopy
Formulation	Powder for oral solution
Regulatory Status	FDA-approved since 2015 (FDA label issued October 2020 update)
Market Position	Competing primarily with other oral bowel prep agents like MiraLAX, Suprep, and GoLYTELY

CLENPIQ uniquely combines picosulfate with magnesium citrate to promote rapid and effective bowel cleansing, appealing to protocols seeking efficient preparation with fewer adverse effects.

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Market Dynamics: Drivers and Barriers

What are the Main Market Drivers?

Drivers	Description	Impact
Increasing Prevalence of Colorectal Conditions	Rising incidence of colorectal cancer, inflammatory bowel disease (IBD), and polyps boost demand for colonoscopies	Expanding market size, estimated to grow at CAGR of about 6% globally (2021–2028) [1]
Growing Screening Programs	Adoption of national colorectal screening guidelines (e.g., USPSTF recommendations)	Sustained, increasing utilization of bowel prep agents
Advancements in Bowel Prep Technology	Development of safer, more effective, and more patient-friendly formulations	Facilitates market expansion for new agents like CLENPIQ
Patient Preference for Shorter Prep Regimens	Demand for less onerous bowel prep protocols	CLENPIQ’s rapid action supports this shift
Regulatory Approvals and Label Claims	Updated approvals enhancing safety profile	Boosts clinician confidence and prescribing rate

What Challenges and Barriers Are Impacting Growth?

Barriers	Description	Potential Impact
Pricing and Reimbursement Constraints	High costs and varying insurance coverage limit access	Limits adoption in cost-sensitive markets
Stringent Regulatory Frameworks	Regulatory delays and post-market restrictions	Hinder new product launches and market expansion
Patient Acceptance and Compliance Issues	Taste, volume, and adverse effects influence adherence	Risks lower utilization rates
Competitive Landscape	Dominance of established agents like MiraLAX, GoLYTELY	Challenges for new entrants including CLENPIQ
Supply Chain Disruptions	Raw material shortages, geopolitical factors	Potentially impact production & distribution

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Market Structure and Competitive Landscape

Competitor	Product Name	Market Share (Est. 2022)	Strengths	Limitations
Ferring Pharmaceuticals	CLENPIQ	~15-20%	Rapid efficacy, favorable safety profile	Price sensitivity, awareness levels
Baxter International	GoLYTELY	30-35%	Long-standing brand, extensive distribution	Large volume, taste issues
Braintree Laboratories	MiraLAX + Rx formulations	20-25%	Widely used OTC, flexible dosing	Less convenient for prep, prescription required
Other Brands	SURSAN, MoviPrep	Remaining share	Differentiated formulations	Limited market penetration

Note: The market shares are estimations based on industry reports and prescription data aggregators (IQVIA, 2022).

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Financial Trajectory: Revenue Trends & Market Forecast

Historical Revenue and Usage Data

Year	Estimated Global Revenue (USD millions)	Key Notes
2019	~$120 million	Initial uptake, market expansion in US and EU
2020	~$140 million	Increased adoption amidst COVID-19 delays
2021	~$160 million	Market stabilization, new regulatory updates
2022	~$180 million	Growing awareness, expanded insurance coverage

Projected Future Revenue (2023-2028)

Year	Forecasted Revenue (USD millions)	CAGR	Assumptions
2023	~$195 million	8.3%	Continued acceptance, regulatory support
2024	~$210 million	7.7%	Increased market penetration
2025	~$230 million	9.5%	New regulatory clearances in emerging markets, clinical endorsements
2026	~$250 million	8.7%	Introduction of newer formulations or delivery devices
2027	~$275 million	10%	Technological innovations and expanding screening programs
2028	~$300 million	9.1%	Matured market penetration, global adoption

Key Factors Influencing Financial Trajectory

• Market Penetration Rate: Expected to increase as awareness of CLENPIQ’s benefits rises.
• Pricing Strategies: Premium pricing due to unique formulation, with potential discounts in competitive scenarios.
• Reimbursement Policies: Coverage expansion in US and EU enhances adoption.
• Emerging Markets: Entry into Asia-Pacific and Latin America predicted to contribute substantially after 2025.

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Regulatory and Policy Environment

Region	Regulatory Agency	Key Policies & Impact	Recent Developments
United States	FDA	510(k) approval, label updates	2020 safety profile enhancement
European Union	EMA	CE marking, MDR compliance	Expanded indications
Japan	PMDA	Approved in 2017	Growth potential via local partnerships
China, India	CFDA, CDSCO	Pending approvals	Market growth driven by increasing colon cancer incidence

Reimbursement & Pricing Policies

• US Medicare/Medicaid favor cost-effective bowel prep options.
• Private insurers increasingly reimburse newer agents with demonstrated safety.
• Price-setting often influenced by competitive landscape and reimbursement negotiations.

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Comparative Analysis: CLENPIQ vs. Alternatives

Feature	CLENPIQ	MiraLAX + Gatorade	GoLYTELY	Suprep
Preparation Time	~1 hour	2-3 hours	4 hours	1 hour
Dosing Volume	Lower (~237g powder)	Higher (~255g powder + fluids)	Larger volume (~4L)	Moderate (16 oz + 16 oz)
Taste & Tolerance	Generally well-tolerated	Variable	Large volume discomfort	Tastes better, more tolerable
Efficacy	High	Moderate	High	Moderate
Adverse Effects	Fewer electrolytes disturbances	Electrolyte imbalance risk	Electrolyte risk	Electrolyte disturbances

Implication: CLENPIQ’s rapid and tolerable profile positions it favorably, especially for outpatient and patient-conscious applications.

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FAQs: Key Considerations About CLENPIQ

1. How does CLENPIQ compare to other bowel preparation agents in terms of safety?
   CLENPIQ has demonstrated a favorable safety profile, with fewer electrolyte disturbances compared to traditional cathartic preparations like GoLYTELY, especially when used with patient-specific dosing guidance.

2. What are the main regulatory milestones for CLENPIQ?
   FDA approval in 2015; subsequent label updates in 2020 expanded indications and improved safety messaging, facilitating broader use.

3. How does reimbursement influence CLENPIQ’s market penetration?
   Favorable reimbursement policies in the US and EU incentivize clinician adoption, though high drug costs remain a barrier in some regions.

4. What are the upcoming innovations likely to impact CLENPIQ’s market?
   Development of lower-volume formulations, taste-masking technologies, and enhanced delivery devices are expected to increase compliance and expand market share.

5. How does the ongoing COVID-19 pandemic affect CLENPIQ’s sales?
   Delays in elective procedures and screening programs temporarily dampened growth in 2020–2021 but has since rebounded with resumption of routine colonoscopies.

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Key Takeaways

• The global bowel prep market is projected to grow at a CAGR of approximately 7-9% till 2028, driven by rising colorectal cancer screening and technological advances.
• CLENPIQ’s rapid efficacy, safety profile, and patient compliance advantages position it favorably against traditional preparations.
• Reimbursement policies and regulatory support are critical levers for market expansion, especially in emerging markets.
• Competition remains intense, with established brands like GoLYTELY and MiraLAX dominating. Differentiation through safety, tolerability, and convenience remains essential.
• Future growth hinges on innovation, market penetration strategies, and navigating reimbursement frameworks.

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References

[1] MarketWatch. (2022). "Global Bowel Preparation Market Size, Share & Trends Analysis."
[2] IQVIA. (2022). "Prescription Data & Market Share Reports."
[3] FDA. (2020). "Clenpiq Label Update."
[4] Research and Markets. (2021). "Global Colonoscopy & Bowel Preparation Market Forecast."
[5] U.S. Preventive Services Task Force. (2021). "Colorectal Cancer Screening Guidelines."

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This detailed analysis offers business professionals an authoritative, data-driven overview of CLENPIQ’s market environment and financial future, facilitating informed decision-making.