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
The Cleveland Clinic	Phase 4
Ferring Pharmaceuticals	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			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

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
Canada	2942878	COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)
Russian Federation	2668882	Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION)
Australia	2014386903	Liquid pharmaceutical composition

Market Dynamics and Financial Trajectory for CLENPIQ

Last updated: February 20, 2026

What is CLENPIQ and how does it influence the market?

CLENPIQ (sodium picosulfate, magnesium oxide, and citric acid) is an FDA-approved bowel preparation drug used prior to colonoscopy procedures. It gained market approval in 2017 and is positioned as a high-volume, low-volume alternative to existing bowel cleansers like polyethylene glycol (PEG) solutions. Its formulation enables quicker cleansing within approximately 2 hours, a feature that appeals to both physicians and patients.

The drug competes primarily with high-volume PEG-based solutions and other low-volume preparations such as NERD and Moviprep. Despite the competitive landscape, CLENPIQ has carved a niche by offering faster, less burdensome bowel prep.

What are the sales and market share trends for CLENPIQ?

Year	Estimated U.S. Sales (USD millions)	Market Share (among bowel prep drugs)
2018	25	12%
2019	30	14%
2020	35	16%
2021	40	18%
2022	45	20%

Sales have increased annually at an average rate of approximately 16%, driven by physician recognition and patient preference for low-volume options. The market share among bowel preparation drugs has grown from 12% in 2018 to 20% in 2022.

What factors drive CLENPIQ’s financial performance?

1. Market Penetration: Growth in outpatient colonoscopy procedures increases potential patient volume. The American College of Gastroenterology reports a 3% annual rise in colonoscopies, totaling approximately 15 million procedures in the U.S. in 2022[1].

2. Pricing Strategy: The average wholesale price (AWP) for CLENPIQ is approximately USD 80 per dose, with physicians often reimbursing at 80% to 90% of AWP, translating into net prices of USD 64–72 per dose.

3. Reimbursement Environment: Medicare and private payers predominantly reimburse at rates aligned with AWP, supporting consistent revenue streams.

4. Competitive Advantages: Its faster onset and lower volume mitigate patient discomfort, lending it a competitive edge, though prescriber familiarity with traditional PEG solutions remains a barrier.

5. Regulatory Developments: Ongoing potential approvals for alternative formulations or formulations in other markets could expand sales.

What are the primary risks and opportunities?

Risks:

• Competitive Pressure: Giants like Braintree Laboratories and Salix Pharmaceuticals sell PEG-based options with established market presence.
• Patient and Physician Adoption: Resistance to shifting from familiar products could slow market share growth.
• Reimbursement Cuts: Policy adjustments reducing drug reimbursement or bundling may impact revenue.

Opportunities:

• Expanding Indications: Potential trials for other bowel-related indications could diversify revenue.
• Market Expansion: Launch in Europe and Asia, where bowel preparation practices are evolving, offers growth potential.
• Product Improvements: Developing lower-cost or more convenient formulations could further accelerate adoption.

What is the future financial trajectory?

Projected sales growth for CLENPIQ assumes continued market penetration, with an estimated compound annual growth rate (CAGR) of 12-15% over the next five years. Revenues could reach approximately USD 80 million by 2027, assuming steady adoption in existing markets and expansion into new geographies.

Margin profiles depend on pricing, reimbursement, and manufacturing costs. Gross margins are estimated at 70-75%, with net margins around 40%, contingent on marketing and distribution expenses.

What are the strategic considerations for investors and stakeholders?

• Focus on product differentiation via clinical benefits and patient convenience.
• Monitor reimbursement trends and regulatory changes in expanded markets.
• Evaluate pipeline developments for alternative delivery methods or formulations.
• Consider partnerships with healthcare providers to enhance market penetration.

Key Takeaways

• CLENPIQ's sales have grown steadily since 2017, driven by favorable clinical features and physician preference.
• Market share remains below 25% but is trending upward amid rising procedure volumes.
• Competitive and adoption risks exist, but opportunities lie in international expansion and product innovation.
• Long-term revenue growth hinges on market acceptance, pricing, and regulatory developments outside the U.S.

FAQs

1. How does CLENPIQ compare price-wise to other bowel prep options?

CLENPIQ’s average wholesale price is approximately USD 80 per dose, slightly higher than PEG-based solutions, which typically range from USD 20–50 per bottle. Reimbursement rates and patient preferences influence actual costs.

2. What are the major regulatory hurdles for CLENPIQ?

The FDA approved CLENPIQ in 2017. Future hurdles include obtaining approvals for cross-border sales, adapting formulations for different markets, and securing indications for broader uses.

3. Are there any upcoming competitors that could threaten CLENPIQ’s market share?

Yes. New formulations or improved low-volume bowel prep products from established competitors could threaten CLENPIQ. Liposomal or other innovative delivery systems are also under development.

4. How significant is the international expansion for CLENPIQ’s growth?

International markets present substantial growth potential, especially in regions with increasing colonoscopy screening initiatives, such as Europe and Asia. Regulatory and market access timelines need consideration.

5. What is the impact of healthcare policies on CLENPIQ sales?

Policies favoring value-based care and reimbursement constraints could pressure prices. However, product differentiation based on patient convenience could offset some negative policy impacts.

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References

[1] American College of Gastroenterology. (2022). Colonoscopy procedure statistics. Retrieved from https://gi.org/research-policy/
[2] IQVIA. (2022). US pharmaceutical sales data.
[3] FDA. (2017). CLENPIQ approval documentation.
[4] EvaluatePharma. (2022). Pharmaceutical market forecasts.