PREPOPIK Drug Patent Profile

Which patents cover Prepopik, and when can generic versions of Prepopik launch?

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

This drug has thirty-two patent family members in twenty-five countries.

The generic ingredient in PREPOPIK 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 Prepopik

There have been seven 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 PREPOPIK

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for PREPOPIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREPOPIK
DailyMed Link:	PREPOPIK at DailyMed

See drug prices for PREPOPIK

See drug sales revenues for PREPOPIK

Recent Clinical Trials for PREPOPIK

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

Sponsor	Phase
The Cleveland Clinic	Phase 4
Ferring Pharmaceuticals	Phase 4
Ferring Pharmaceuticals	Phase 3

See all PREPOPIK clinical trials

Paragraph IV (Patent) Challenges for PREPOPIK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREPOPIK	Oral Solution	citric acid; magnesium oxide; sodium picosulfate	10 mg, 3.5 g, and 12 g	202535	1	2014-05-21

US Patents and Regulatory Information for PREPOPIK

PREPOPIK is protected by two 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	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,450,338		Y
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,481,083		Y

International Patents for PREPOPIK

When does loss-of-exclusivity occur for PREPOPIK?

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Saudi Arabia

Slovenia

South Africa

South Korea

Spain

Taiwan

United Kingdom

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 PREPOPIK around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20180215
United Kingdom	0805953
South Korea	101330096
Spain	2659716
Mexico	2010003588	PROCESO PARA LA MANUFACTURA DE UN PRODUCTO FARMACEUTICO. (PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT.)
Jordan	3406	عملية لتصنيع منتج صيدلاني يشتمل على حمض الستريك ،أكسيد ماغنسيوم، بيكربونات بوتاسيوم وبيكو كبريتات صوديوم، تركيبة صيدلانية تشتمل على حبيبات متحصل عليها بواسطة هذه العملية ومنتجات وسيطة منها (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF)
Russian Federation	2473332	СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ (METHOD OF MANUFACTURING PHARMACEUTICAL PRODUCT, CONTAINING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITIONS, CONTAINING THUS OBTAINED GRANULES AND INTERMEDIATE COMPOUND)

PREPOPIK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PREPOPIK

Introduction to PREPOPIK

PREPOPIK, a low-volume, orange-flavored, dual-acting laxative containing sodium picosulfate, magnesium oxide, and anhydrous citric acid, is approved by the FDA for colonoscopy preparation in adults and, since 2018, in pediatric patients aged 9 years and older[1][4].

Market Drivers

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

Rising Incidences of Colorectal Diseases

The increasing prevalence of colorectal diseases is a significant driver, as more patients require colonoscopies for diagnosis and prevention. This trend is expected to continue, fueling demand for effective bowel preparation drugs[3].

Preference for Effective and Less Invasive Methods

There is a growing preference for bowel preparation methods that are both effective and less invasive. PREPOPIK, with its low-volume and split-dosing regimen, aligns well with this preference, enhancing patient compliance and comfort[1][3].

Technological Advancements

Advancements in drug development and formulation have led to the creation of more patient-friendly and effective bowel preparation solutions. PREPOPIK's dual-acting mechanism as a stimulant and osmotic laxative is an example of such innovation[3].

Market Trends

Growing Focus on Patient-Friendly Products

The market is witnessing a growing focus on developing products that are easier for patients to use. PREPOPIK's low-volume and split-dosing options make it more tolerable and convenient, contributing to its market appeal[1][3].

Increasing Adoption of Home-Based Preparation

There is an increasing trend towards home-based bowel preparation methods, which offer greater convenience and comfort to patients. PREPOPIK, being a home-administered solution, benefits from this trend[3].

Competitive Landscape

Major Players

The colonoscopy bowel preparation drugs market is dominated by companies such as Takeda Pharmaceutical Company Limited, Ferring Pharmaceuticals, and Salix Pharmaceuticals. These companies are engaged in product innovation, strategic collaborations, and geographical expansion to strengthen their market positions[3].

Ferring Pharmaceuticals' Position

Ferring Pharmaceuticals, the manufacturer of PREPOPIK, has a strong global presence in the gastrointestinal market. The approval of PREPOPIK marks Ferring's entry into the U.S. gastroenterology market, where it aims to expand its franchise focused on gastrointestinal health[1].

Financial Trajectory

Market Size and Growth

The global colonoscopy bowel preparation drugs market is expected to grow significantly from 2024 to 2028, driven by the increasing demand for effective and less invasive bowel preparation methods. While exact financial figures for PREPOPIK are not publicly disclosed, the overall market growth indicates a positive financial trajectory for the product[3].

Revenue and Market Share

PREPOPIK's approval and subsequent market performance have contributed to Ferring Pharmaceuticals' revenue. The product's non-inferiority and, in some cases, superiority over competitors in clinical trials have helped it gain market share. However, the exact revenue figures and market share are not publicly available[1].

Challenges and Opportunities

• High Costs and Side Effects: Despite its advantages, PREPOPIK faces challenges such as high costs and potential side effects, which can hinder market growth. Common adverse reactions include nausea, headache, and vomiting[1].
• Expansion in Emerging Economies: There is an opportunity for PREPOPIK to expand into emerging economies, where the demand for effective bowel preparation drugs is increasing[3].
• Growing Demand for Over-the-Counter Options: The market is seeing a growing demand for over-the-counter bowel preparation drugs, which could be a future opportunity for PREPOPIK if it transitions from a prescription-only to an over-the-counter product[3].

Regulatory and Safety Considerations

FDA Approval and Pediatric Use

PREPOPIK was initially approved for adult use in 2012 and later for pediatric patients aged 9 years and older in 2018. The safety and efficacy in pediatric patients were supported by clinical trials that showed similar success rates to the comparator drug[1][4].

Postmarketing Surveillance

The FDA continues to monitor adverse events associated with PREPOPIK through postmarketing pharmacovigilance reviews. These reviews have not identified any significant safety signals or increased severity of labeled adverse events in pediatric patients[4].

Key Takeaways

• Market Growth: The colonoscopy bowel preparation drugs market is driven by increasing incidences of colorectal diseases and a preference for effective, less invasive methods.
• Competitive Advantage: PREPOPIK's low-volume and split-dosing regimen make it a competitive product in the market.
• Financial Potential: The overall market growth and PREPOPIK's clinical superiority suggest a positive financial trajectory.
• Challenges: High costs and side effects are challenges that need to be addressed.
• Opportunities: Expansion into emerging economies and potential transition to over-the-counter status are future opportunities.

FAQs

1. What is PREPOPIK used for? PREPOPIK is used for the cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients aged 9 years and older[1].

2. What are the common side effects of PREPOPIK? Common side effects include nausea, headache, and vomiting[1].

3. How is PREPOPIK administered? PREPOPIK can be administered in a split-dose regimen, taken in the evening before and on the morning of the procedure, or as a day-before dosing for certain patients[1].

4. Is PREPOPIK approved for pediatric use? Yes, PREPOPIK is approved for use in pediatric patients aged 9 years and older since 2018[4].

5. What companies are major players in the colonoscopy bowel preparation drugs market? Major players include Takeda Pharmaceutical Company Limited, Ferring Pharmaceuticals, and Salix Pharmaceuticals[3].

Cited Sources

1. FDA Approves Ferring's PREPOPIK™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for Colonoscopy Prep - PR Newswire.
2. Annual Reports - AnnualReports.com.
3. Colonoscopy Bowel Preparation Drugs Market Analysis - Technavio.
4. Pediatric Postmarketing Pharmacovigilance Review - FDA.
5. Colonoscopy Bowel Preparation Drugs Market Analysis - BioSpace.