CLENPIQ Drug Patent Profile

When do Clenpiq patents expire, and when can generic versions of Clenpiq launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLENPIQ

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			Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes			Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes			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)
Japan	2017508815	液状医薬組成物
Mexico	366499	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
South Korea	101420315

Investment Scenario and Fundamentals Analysis for CLENPIQ

Last updated: February 19, 2026

What is CLENPIQ and what is its target indication?

CLENPIQ (NaCl, KCl, and polyethylene glycol solution) is a bowel prep product approved by the FDA for colonoscopy preparation. It is used in adults to clear the bowel before procedures. The drug is marketed by Ferring Pharmaceuticals, reflecting a focus on the gastrointestinal (GI) market.

What is the market size and growth trajectory for bowel prep products?

The global bowel preparation market was valued at approximately $940 million in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2022 to 2027, driven primarily by increasing colonoscopy procedures linked to colorectal cancer screening programs.

Year	Market Size (USD billion)	CAGR	Notes
2022	0.98	4.2%	Based on current estimates
2027	1.20	—	Projected

Major competitors include MiraLAX, Golytely, and new formulations with enhanced tolerability and efficacy.

What are the key product features and positioning?

CLENPIQ offers a high-volume, osmotic laxative solution that requires split dosing. It emphasizes improved palatability and adherence, targeting patients who prefer fewer side effects and better tolerability. Differentiators include its proprietary formulation and strong branding within the Ferring portfolio.

What are the sales and revenue trends?

Ferring reported that CLENPIQ generated approximately $120 million globally in 2022, with over 60% of sales in North America. Market penetration remains moderate due to competition and procedural volume fluctuations but has shown steady growth over the past three years.

What are the regulatory and patent considerations?

CLENPIQ’s patent protection extends into the late 2020s, with the original patent expiring in 2027. Regulatory pathways in Europe mirror the US approval process, and approval in emerging markets is ongoing or planned, offering potential revenue expansion.

What are the key risk factors affecting investment?

• Market Competition: New formulations with superior tolerability or efficacy could threaten CLENPIQ's market share.
• Regulatory Risks: Potential labeling restrictions or series of adverse event reports could impact sales.
• Procedural Volume Variance: Declines in colonoscopy procedures due to alternative screening methods reduce demand.
• Patent Expiry: The approaching expiration risks generic competition unless extended or related patents are secured.

What are the growth opportunities?

• Line Extensions: Development of reduced-volume or lower-volume formulations could enhance compliance.
• Geographical Expansion: Penetrating emerging markets with high colorectal cancer prevalence.
• Combination Regimens: Positioning as part of combination therapies for bowel cleansing or related GI procedures.

What is the broader investment outlook?

While CLENPIQ operates within a stable but competitive GI prep market, its future growth depends on market penetration, expanding indications, and mitigating patent expiration risks. Given its current revenue profile and evolving landscape, it offers moderate upside with substantial competition present.

Key Takeaways

• The product addresses a sizable, stable market with modest growth.
• Revenue peaked at around $120 million globally in 2022.
• Competition from established and new bowel prep formulations remains intense.
• Patent protections last until 2027; generic threat increases thereafter.
• Opportunities exist in product line extensions and growth in emerging markets.

Frequently Asked Questions

How does CLENPIQ compare to other bowel prep products?

It offers a split-dose, higher-volume solution designed for better tolerability. Competitors may offer lower-volume or flavored options, influencing patient adherence and satisfaction.

What is the main driver for growth in the bowel prep market?

An increase in colorectal cancer screening initiatives and procedural volumes, particularly in North America and Europe.

How significant are patent expirations for CLENPIQ?

Patents are set to expire in 2027, raising the risk of generic entrants that could erode sales unless new patents or formulations are secured.

Are there regulatory hurdles for expanding CLENPIQ’s indications?

Yes, additional approvals or label expansions would require demonstrating safety and efficacy for alternative uses, involving costly clinical trials.

What is the potential for international growth?

High in emerging regions with rising healthcare infrastructure and colorectal screening programs, but regulatory and reimbursement considerations vary.

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Sources

[1] MarketsandMarkets. (2022). Bowel Preparation Market - Global Forecast to 2027.
[2] Ferring Pharmaceuticals. (2022). Annual Report.
[3] U.S. Food and Drug Administration. (2022). CLENPIQ NDA.
[4] Grand View Research. (2022). Gastrointestinal Diagnostics Market Analysis.