PLENVU Drug Patent Profile

When do Plenvu patents expire, and what generic alternatives are available?

Plenvu is a drug marketed by Salix and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-nine patent family members in thirty-seven countries.

The generic ingredient in PLENVU is ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Plenvu

There have been three 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.

Indicators of Generic Entry

Summary for PLENVU

International Patents:	159
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Drug Prices:	Drug price information for PLENVU
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PLENVU
What excipients (inactive ingredients) are in PLENVU?	PLENVU excipients list
DailyMed Link:	PLENVU at DailyMed

See drug prices for PLENVU

Recent Clinical Trials for PLENVU

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

Sponsor	Phase
Lund University	Phase 3
Region Skane	Phase 3
Odense University Hospital	Phase 3

See all PLENVU clinical trials

Paragraph IV (Patent) Challenges for PLENVU

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PLENVU	For Oral Solution	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch	209381	1	2018-12-06

US Patents and Regulatory Information for PLENVU

PLENVU is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	9,326,969
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	10,780,112		Y
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	10,792,306		Y

International Patents for PLENVU

When does loss-of-exclusivity occur for PLENVU?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

India

Ireland

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 PLENVU around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	11201606834Q	METHOD OF CLEANSING THE COLON
China	106102738	清洗结肠的方法 (Method of cleansing the colon)
Israel	227582	תכשיר לקולונוסקופיה (Colonoscopy-preparation)

Supplementary Protection Certificates for PLENVU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
3141251	C202130017	Spain		PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016
3141251	132021000000044	Italy		PRODUCT NAME: UN PRODOTTO MEDICINALE COSTITUITO DA UNA COMBINAZIONE DI UNA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E UNA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA, LA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, SOLFATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO E LA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, ACIDO ASCORBICO, ASCORBATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO.(PLENVU); AUTHORISATION NUMBER(S) AND DATE(S): IS/1/17/083/01, 20171016;045671017, 045671029, 045671031, 045671043, 045671056, 20171213

PLENVU Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PLENVU

Introduction to PLENVU

PLENVU, developed by Salix Pharmaceuticals and its partner Norgine B.V., is a prescription medication designed to clean the colon before a colonoscopy. It is the first and only 1-liter polyethylene glycol (PEG) bowel cleansing preparation approved by the FDA, offering both same-day morning-of-colonoscopy and 2-day split-dosing regimens[1].

Market Drivers

Rising Incidences of Colorectal Diseases

The increasing prevalence of colorectal diseases is a significant driver for the demand of effective bowel preparation drugs like PLENVU. As the incidence of these diseases rises, so does the need for colonoscopies, thereby boosting the market for bowel preparation medications[3].

Increasing Preference for Effective and Less Invasive Methods

Patients and healthcare providers are increasingly seeking bowel preparation methods that are effective, less invasive, and more patient-friendly. PLENVU's lower volume requirement and improved palatability make it an attractive option, driving its adoption in the market[1][3].

Technological Advancements in Drug Development

Advancements in drug development have led to the creation of more efficient and tolerable bowel preparation solutions. PLENVU's formulation, which includes polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride, reflects these technological advancements[1].

Market Trends

Growing Focus on Patient-Friendly Bowel Preparation Drugs

There is a growing focus on developing bowel preparation drugs that are easier for patients to use. PLENVU's approval for same-day dosing and its lower volume compared to other preparations align with this trend, making it more appealing to patients and healthcare providers[1].

Increasing Adoption of Home-Based Bowel Preparation Methods

The shift towards home-based bowel preparation methods is another trend in the market. PLENVU, being a convenient and less voluminous option, fits well into this trend, allowing patients to prepare for colonoscopies in the comfort of their own homes[3].

Financial Performance and Trajectory

Revenue and Sales

PLENVU has contributed significantly to the revenue of Salix Pharmaceuticals and its parent company, Bausch Health. In the financial reports for 2021 and 2022, PLENVU's sales were highlighted as part of the company's overall performance. For instance, in the fourth quarter and full year of 2021, PLENVU generated notable revenues, contributing to the overall financial health of Bausch Health[5].

Segment Performance

The Salix segment, which includes PLENVU, reported revenues of $581 million for the fourth quarter and $2,090 million for the full year of 2022. This indicates a steady and significant contribution from PLENVU to the company's overall revenue[2].

Organic Growth

Excluding the impacts of foreign exchange and divestitures, the Salix segment showed organic revenue growth. This organic growth reflects the increasing adoption and market acceptance of PLENVU, among other products in the segment[2].

Challenges and Opportunities

Competition and Market Dynamics

The bowel preparation market is competitive, with several other products available. However, PLENVU's unique features, such as its lower volume and same-day dosing option, help it stand out in the market. The growing demand for effective and patient-friendly bowel preparation methods presents opportunities for further market penetration[1][3].

Expansion in Emerging Economies

There is an opportunity for PLENVU to expand into emerging economies where the demand for bowel preparation drugs is growing due to increasing healthcare needs and awareness. This expansion could further boost the financial trajectory of PLENVU[3].

Growing Demand for Over-the-Counter Options

While PLENVU is currently a prescription medication, there is a growing demand for over-the-counter bowel preparation drugs. If PLENVU were to be approved for over-the-counter use in the future, it could significantly expand its market reach and revenue potential[3].

Clinical and Regulatory Aspects

Clinical Trials and Approval

PLENVU's approval was based on multiple Phase 3 clinical trials, including the NOCT study, which compared PLENVU to other bowel cleansing solutions. The FDA approval for same-day dosing and the positive outcomes from these trials have been crucial in establishing PLENVU's position in the market[1].

Risk Management and Safety

The Risk Management Plan (RMP) for PLENVU outlines the drug's efficacy and safety profile. The plan includes details on pharmacokinetic studies and the management of potential drug interactions, ensuring that PLENVU is used safely and effectively[4].

Key Takeaways

• Market Drivers: Rising incidences of colorectal diseases, increasing preference for effective and less invasive methods, and technological advancements in drug development.
• Market Trends: Growing focus on patient-friendly bowel preparation drugs and increasing adoption of home-based methods.
• Financial Performance: Significant revenue contribution to Salix Pharmaceuticals and Bausch Health, with organic growth in the Salix segment.
• Challenges and Opportunities: Competition, expansion into emerging economies, and potential for over-the-counter approval.
• Clinical and Regulatory Aspects: FDA approval based on Phase 3 clinical trials and a comprehensive Risk Management Plan.

FAQs

1. What is PLENVU used for? PLENVU is a prescription medication used by adults to clean the colon before a colonoscopy[1].

2. What makes PLENVU unique in the market? PLENVU is the first and only 1-liter PEG bowel cleansing preparation approved by the FDA, offering both same-day morning-of-colonoscopy and 2-day split-dosing regimens[1].

3. How has PLENVU performed financially? PLENVU has contributed significantly to the revenue of Salix Pharmaceuticals and Bausch Health, with the Salix segment showing organic revenue growth[2][5].

4. What are the key market trends affecting PLENVU? The growing focus on patient-friendly bowel preparation drugs and the increasing adoption of home-based methods are key trends[3].

5. What opportunities exist for PLENVU's future growth? Expansion into emerging economies and the potential for over-the-counter approval present significant opportunities for future growth[3].

Cited Sources

1. Salix Announces U.S. Launch of PLENVU®, the First and Only 1-Liter PEG Bowel Cleansing Preparation for Colonoscopies. PR Newswire.
2. Bausch Health Announces Fourth Quarter and Full Year 2022 Results. Bausch Health.
3. Colonoscopy Bowel Preparation Drugs 2024-2028 Market Overview. Technavio.
4. NER1006 (PLENVU/PLEINVUE) RISK MANAGEMENT PLAN (RMP). UK Government.
5. 4Q & FY 2021 - Financial Results - Bausch Health Companies Inc.. Bausch Health.