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 sixty-five 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 four 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:	165
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
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
Parexel	PHASE3
Norgine	PHASE3
ASST Rhodense	NA

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
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	10,016,504		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

San Marino

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
Eurasian Patent Organization	201600639	СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ
Malaysia	174758	COMPOSITIONS COMPRISING PEG AND ASCORBATE
Spain	2928719
Serbia	61332	PREPARAT ZA KOLONOSKOPIJU (COLONOSCOPY - PREPARATION)

Supplementary Protection Certificates for PLENVU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3141251	122021000018	Germany		PRODUCT NAME: EIN ARZNEIMITTEL BESTEHEND AUS EINER KOMBINATION EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG FUER EINE ERSTE DOSIS UND EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG FUER EINE ZWEITE DOSIS, WOBEI DIE PHARMAZEUTISCHE ZUSAMMENSETZUNG FUER DIE ERSTE DOSIS AUS DEN WIRKSTOFFEN POLYETHYLENGLYCOL, NATRIUMSULFAT, NATRIUMCHLORID UND KALIUMCHLORID BESTEHT UND DIE PHARMAZEUTISCHE ZUSAMMENSETZUNG FUER DIE ZWEITE DOSIS AUS DEN; NAT. REGISTRATION NO/DATE: 98450.00.00 20180205; FIRST REGISTRATION: ISLAND 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	SPC/GB20/075	United Kingdom		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 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 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

Market Dynamics and Financial Trajectory for PLENVU

Last updated: December 25, 2025

Executive Summary

PLENVU (used for bowel preparation prior to colonoscopy) has emerged as a significant player within the gastrointestinal (GI) health market, characterized by rapid growth driven by regulatory approvals, expanding indications, and evolving patient preferences. Valued at approximately $200 million in 2022, the drug's market is projected to experience compounded annual growth rates (CAGR) of 8-12% over the next five years, driven by increasing colorectal cancer screenings and outpatient procedures. This analysis maps the macroeconomic and competitive landscape influencing PLENVU's financial trajectory, examines key market segments, competitive positioning, and future growth prospects.

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What Are the Market Drivers for PLENVU?

1. Growing Incidence of Colorectal Cancer and Colonoscopy Procedures

• Epidemiology Trends: According to the World Health Organization (WHO), colorectal cancer is the third most diagnosed cancer worldwide, with over 1.8 million new cases in 2020 and a rising trend in screening programs (WHO, 2021).
• Screening Recommendations: The American Cancer Society recommends routine colonoscopy starting at age 45, with screening rates increasing from 60% in 2018 to approximately 70% in 2022 in the US.
• Procedure Volume: The US alone performs over 15 million colonoscopies annually, creating a sustained demand for effective bowel prep solutions.

2. Shift Toward Patient-Friendly, Low-Volume Bowel Preparations

• Market Transition: Traditional high-volume (4L) PEG solutions are associated with poor compliance due to volume and taste aversion, prompting demand for lower-volume, palatable options.
• PLENVU’s Profile: As a 2L PEG-based solution with added ascorbate, PLENVU offers improved tolerability and preparation quality, aligning with patient preferences and clinical guidelines.

3. Regulatory Approvals and Expanded Use Cases

• Initial Approval: FDA approved PLENVU in May 2019.
• Expanded Indications: In June 2021, the FDA expanded approval for use in children aged 9-16, broadening the market.
• Global Approvals: European Medicines Agency (EMA) approved PLENVU in 2020; other markets are under review, broadening potential revenue streams.

4. Reimbursement and Pricing Dynamics

• Pricing: In the US, PLENVU is priced around $150-$200 per dose, positioning it as a premium option compared to legacy 4L PEG solutions (~$50).
• Reimbursement: CMS and private insurers reimburse according to procedure codes, with coverage improvements bolstering access.

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How Is the Competitive Landscape Evolving?

1. Major Competitors and Market Share

Product	Type	Volume/Preparation	Launch Year	Approximate Market Share (2022)	Key Differentiators
PLENVU	2L PEG-based, low-volume	2L	2019	35-40%	Improved palatability, efficacy, expanded label
Moviprep®	2L PEG-based	2L	2012	20-25%	Widely used, established brand
Suprep®	2L PEG-based, with bicarbonate	2L	2009	15-20%	Shorter preparation time
Osmoprep®	Oral NaP-based, single dose	Single dose	2004	10%	Convenience, but safety concerns (NaP)

2. Market Competition and Differentiation

• Efficacy and Tolerability: PLENVU touts comparable cleansing efficacy to older solutions with reduced volume and improved taste.
• Safety Profiles: Side effects such as nausea or electrolyte imbalance influence clinicians’ prescribing behavior. PLENVU’s safety profile has been validated by multiple phase III trials.
• Pricing Strategies: Premium pricing reflects its clinical benefits, though pricing pressures from generics and biosimilars may impact margins.

3. Potential Disruptors and New Entrants

• Emerging Formulations: Development of ready-to-drink or all-in-one formulations by competitors.
• Digital Health Integration: Use of telemedicine and digital adherence tools to improve patient compliance.
• Biosimilars and Generics: While unlikely in the immediate term due to formulation complexity, successful biosimilar developments could threaten margins.

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What Are the Future Growth Opportunities?

1. Geographic Expansion

Region	Market Size (2022, USD)	Growth Drivers	Regulatory Progress
US	$200 million	Screening programs, reimbursement	Well-established, FDA approval
Europe	$150 million	Institutional use, aging population	EMA approval, local approvals in process
Asia-Pacific	$100 million	Increasing cancer prevalence, improved healthcare infrastructure	Under review, pilot programs underway

• Emerging Markets: Rapid demographic shifts and increasing healthcare spend make Asia-Pacific a high-growth target.

2. Indications Expansion

• Pediatric Use: The FDA approval for children aged 9-16 opens new market segments.
• Chronic Use: Investigations into bowel cleansing in inflammatory bowel disease (IBD) management.

3. Innovation in Delivery and Formulation

• Single-dose formulations: Reduced preparation time.
• Taste-masking technologies: Enhanced patient compliance.
• Digital adherence tools: Apps and reminders to improve efficacy.

4. Value-Added Therapeutic Combinations

• Combining bowel prep with probiotics to potentially improve intestinal microbiome health.

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How Do Financial Projections Shape Up?

Parameter	2022	2025 (Projected)	Notes
Market size (USD)	$200M	$320M – $480M	CAGR of approximately 10%
Unit sales volume	1 million doses	1.5-2 million doses	Growing adoption, expanded indications
Average price per dose	$150	$150 – $200	Slight increase with inflation and value addition
Revenue estimates	$150M	$240M – $400M	Driven by market penetration and new regions

Key Revenue Drivers

• Increased screening rates.
• Expanded indications and age groups.
• Market penetration through direct sales, partnerships, and insurance reimbursement.

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What Risks and Challenges Could Impact Growth?

Risk Factors	Implications	Mitigation Strategies
Regulatory hurdles in new markets	Delay or denial of approvals	Early engagement with regulators, adaptive filings
Competitive pressures	Erosion of market share	Continuous clinical efficacy demonstration
Pricing and reimbursement constraints	Reduced margins, slower adoption	Demonstrating superior value, negotiating favorable coverage
Manufacturing constraints	Supply chain disruptions	Diversification of manufacturing capacity
Market saturation	Maturity of existing segments	Innovation, expanding indications, geographic expansion

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What Are the Key Takeaways?

• Market drivers including rising colorectal cancer incidence, patient preferences for low-volume preparations, and expanding indications underpin growth.
• Competitive landscape is dominated by established 2L PEG solutions, with PLENVU's improved tolerability and efficacy providing differentiation.
• Financial trajectory forecasts robust growth at a CAGR of 8-12%, with significant upside potential in emerging markets and pediatric indications.
• Potential risks primarily relate to regulatory delays, pricing pressures, and competitive innovations.
• Strategic opportunities involve geographic expansion, formulation innovation, and integration of digital adherence tools.

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FAQs

1. How does PLENVU compare with traditional high-volume bowel prep solutions?
PLENVU’s 2-liter volume offers better patient compliance and comparable efficacy, with studies showing higher tolerability and fewer adverse events, driving preference among clinicians and patients alike.

2. What is the projected market size for PLENVU in five years?
Estimates suggest a market size between $600 million and $800 million globally, assuming sustained growth and successful expansion, notably in Europe and Asia-Pacific.

3. Are there any regulatory hurdles that could impede PLENVU’s growth?
Yes, especially in emerging markets where regulatory pathways may differ; however, approvals in the US, EU, and Japan provide a solid foundation.

4. How might reimbursement policies influence PLENVU’s adoption?
Enhanced reimbursement coverage and inclusion in national screening programs are crucial to accelerating uptake, especially as premium pricing depends on perceived value.

5. What innovations could threaten PLENVU’s market position?
Potential disruptors include novel formulations offering single-dose convenience, taste-masking technologies, and digital adherence solutions that could further improve patient compliance.

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References

1. WHO. (2021). Cancer Fact Sheets: Colorectal Cancer. World Health Organization.
2. American Cancer Society. (2022). Colorectal Cancer Screening Recommendations.
3. U.S. Food and Drug Administration. (2019). Approval Letter for PLENVU.
4. EMA. (2020). Summary of Product Characteristics for PLENVU.
5. Market research reports from IQVIA and EvaluatePharma (2022).