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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in ten countries.

The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are 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:	13
US Patents:	3
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 three 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	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
Mexico	366499	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
Mexico	2016011938	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
South Korea	101420315

CLENPIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLENPIQ

Introduction

CLENPIQ, a prescription medication developed by Ferring Pharmaceuticals, is designed for colonoscopy preparation. It is a ready-to-drink, cranberry-flavored solution containing sodium picosulfate, magnesium oxide, and anhydrous citric acid. Here, we delve into the market dynamics and financial trajectory of CLENPIQ.

Market Drivers

The market for colonoscopy bowel preparation drugs, including CLENPIQ, is driven by several key factors:

Rising Incidences of Colorectal Diseases

The increasing prevalence of colorectal diseases, which are the third most common cancer and the second leading cause of cancer death in the United States, drives the demand for effective bowel preparation medications[1][3].

Preference for Effective and Less Invasive Methods

There is a growing preference for bowel preparation methods that are effective, less invasive, and more patient-friendly. CLENPIQ, being a ready-to-drink solution, aligns with this trend[3].

Technological Advancements

Continuous technological advancements in drug development contribute to the market growth by offering better, safer, and more convenient options for patients[3].

Market Trends

Several trends are shaping the market for CLENPIQ and similar drugs:

Growing Focus on Patient-Friendly Products

There is an increasing focus on developing bowel preparation drugs that are easier for patients to use, such as ready-to-drink solutions like CLENPIQ. This trend enhances patient compliance and satisfaction[3].

Home-Based Bowel Preparation

The adoption of home-based bowel preparation methods is on the rise, making products like CLENPIQ more appealing as they can be administered at home, reducing the need for hospital visits[3].

Market Segmentation

The colonoscopy bowel preparation drugs market is segmented based on drug types and applications:

Drug Types

The market is segmented into PEG-based, Sodium Picosulfate-based, and other types of drugs. PEG-based drugs currently dominate the market due to their effectiveness and fewer side effects, but Sodium Picosulfate-based drugs like CLENPIQ are gaining traction[3].

Applications

The market is segmented into hospitals, clinics, and ambulatory surgical centers. CLENPIQ is used across these settings, particularly in outpatient procedures where its ready-to-drink format is advantageous[3].

Regional Analysis

The market for colonoscopy bowel preparation drugs, including CLENPIQ, varies by region:

North America and Europe

These regions are the largest markets due to the high prevalence of colorectal diseases and robust healthcare infrastructure. CLENPIQ has been approved by the FDA and is available in these markets[1][3].

Emerging Economies

There is potential for market expansion in emerging economies, where the demand for effective and affordable bowel preparation drugs is increasing[3].

Financial Trajectory

The financial trajectory of CLENPIQ is influenced by several factors:

Cost Without Insurance

CLENPIQ is priced at around $229 for a full retail prescription, which includes two 160 ml doses. This cost can be a barrier for some patients, but discount programs and insurance coverage can reduce the expense[2][5].

Discounts and Insurance Coverage

Discount cards, such as those offered by SingleCare, can lower the cost of CLENPIQ to as low as $150. Some insurance plans and Medicare Part D may also cover CLENPIQ, making it more accessible to patients[2][5].

Market Size and Growth

The overall market for colonoscopy bowel preparation drugs is expected to grow, driven by the increasing incidence of colorectal diseases and the preference for effective and less invasive methods. While specific financial projections for CLENPIQ are not detailed, the market's overall growth trajectory suggests a positive outlook for the drug[3].

Competitive Landscape

CLENPIQ operates in a competitive market with other notable players:

Major Competitors

Companies like Takeda Pharmaceutical Company Limited, Salix Pharmaceuticals, and others are key competitors in the market. These companies are focusing on product innovation, strategic collaborations, and expanding their geographical presence to strengthen their market position[3].

Alternative Products

Alternatives to CLENPIQ, such as GoLytely and combinations of MiraLax with Dulcolax, are available and may be more cost-effective. However, these alternatives may have different side effects and drug interactions, making CLENPIQ a preferred choice for some patients[2].

Safety and Efficacy

The safety and efficacy of CLENPIQ have been established through clinical trials:

High Osmolality

CLENPIQ has a higher osmolality compared to other products like Prepopik, which can lead to more diarrhea and a greater risk of dehydration if not managed properly. However, this has been deemed acceptable by regulatory bodies[4].

Pediatric Use

CLENPIQ is approved for use in adults, and there are ongoing studies to expand its indication to pediatric patients. The drug's safety and efficacy in children are being evaluated through post-marketing requirements under the Pediatric Research Equity Act (PREA)[4].

Key Takeaways

• Market Drivers: Increasing incidence of colorectal diseases, preference for effective and less invasive methods, and technological advancements.
• Market Trends: Growing focus on patient-friendly products, increasing adoption of home-based bowel preparation.
• Financial Trajectory: Priced at $229 without insurance, but discounts and insurance coverage can reduce the cost.
• Competitive Landscape: Competes with other bowel preparation drugs, with a unique ready-to-drink format.
• Safety and Efficacy: Established through clinical trials, with ongoing studies for pediatric use.

FAQs

1. What is CLENPIQ used for? CLENPIQ is used for the cleansing of the colon in adults undergoing a colonoscopy.

2. How much does CLENPIQ cost without insurance? CLENPIQ costs around $229 for a full retail prescription without insurance.

3. Are there any discounts available for CLENPIQ? Yes, discount cards and some insurance plans can reduce the cost of CLENPIQ.

4. What are the main ingredients of CLENPIQ? CLENPIQ contains sodium picosulfate, magnesium oxide, and anhydrous citric acid.

5. Is CLENPIQ available for pediatric use? Currently, CLENPIQ is approved for adult use, but there are ongoing studies to expand its indication to pediatric patients.

Cited Sources

1. FDA Approves Ferring's CLENPIQ™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy. PR Newswire.
2. How much is Clenpiq without insurance? SingleCare.
3. Colonoscopy Bowel Preparation Drugs 2024-2028 Market Overview. Technavio.
4. CDTL/Signatory Summary Review of sNDA 209589 Clenpiq. FDA.
5. Clenpiq Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com.