MOVIPREP Drug Patent Profile

Which patents cover Moviprep, and what generic alternatives are available?

Moviprep is a drug marketed by Salix Pharms and is included in one NDA.

The generic ingredient in MOVIPREP 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.

Summary for MOVIPREP

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVIPREP

Paragraph IV (Patent) Challenges for MOVIPREP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVIPREP	For Oral Solution	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch	021881	1	2007-11-27

US Patents and Regulatory Information for MOVIPREP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006	AA	RX	Yes	Yes

International Patents for MOVIPREP

See the table below for patents covering MOVIPREP around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	393711	Sucha kompozycja, dawka jednostkowa, roztwór, sposób przygotowania roztworu do oczyszczania okrężnicy, zestaw i kompozycja oraz sposób oczyszczania okrężnicy ssaka (Dry composition, unit dose, solution, method for the preparation of a solution for colon cleansing, set, and the composition and method for the mammalian colon cleansing)
Australia	2009227838	Colon cleansing compositions
Japan	5660320
Hong Kong	1126678	COLON CLEANSING COMPOSITIONS
Russian Federation	2009105770	СУХАЯ КОМПОЗИЦИЯ ДЛЯ СМЕШИВАНИЯ С ВОДОЙ (ВАРИАНТЫ), ОЧИСТИТЕЛЬНЫЙ ПРЕПАРАТ И НАБОР КОМПОНЕНТОВ ДЛЯ ОЧИСТКИ ТОЛСТОЙ КИШКИ И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ)
Spain	2319093
Germany	08014286

Supplementary Protection Certificates for MOVIPREP

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

Investment Scenario, Market Dynamics, and Financial Trajectory for MOVIPREP

Last updated: February 3, 2026

Summary

MOVIPREP, a bowel preparation medication developed by Fujifilm Holdings Corporation, is used primarily for colonoscopy procedures. Given its niche but essential role in gastrointestinal diagnostics, the product exhibits specific market characteristics influenced by regulatory, technological, and healthcare trends. This analysis explores current investment opportunities, market dynamics, and financial outlook over the next five years, supported by data, competitive positioning, and strategic factors influencing growth.

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Overview of MOVIPREP

Attribute	Details
Active Ingredient(s)	Oral sodium sulfate, magnesium oxide, and other osmotic laxatives
Indication	Bowel cleansing prior to colonoscopy
Regulatory Status	FDA-approved, EMA-approved, granted various market authorizations worldwide
Manufacturing	Fujifilm, with regional manufacturing facilities for supply chain optimization

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Market Landscape and Dynamics

Global Market Size and Segmentation

Region	Market Size (2022, USD billion)	CAGR (2022-2027)	Key Drivers
North America	1.2	4.8%	High prevalence of colorectal cancer, advanced healthcare infrastructure
Europe	0.9	4.3%	Aging population, reimbursement coverage
Asia-Pacific	0.6	7.0%	Rising healthcare expenditure, increasing screening programs
Rest of World	0.3	5.0%	Developing healthcare systems

Total global market value in 2022: approximately USD 3 billion with projections exceeding USD 4 billion by 2027.

Key Market Drivers

• Rising aging populations leading to increased colorectal screening.
• Advances in minimally invasive diagnostic procedures.
• Adoption of digital health and patient management tools.
• Growing public awareness about colorectal health.

Market Challenges and Opportunities

Challenges	Opportunities
Stringent regulatory pathways	New formulation innovations to improve tolerability
Competition from other bowel prep agents	Entry into emerging markets with unmet needs
Patient compliance issues due to taste or tolerability	Digital adherence solutions

Competitive Landscape

Competitors	Key Products	Market Share (estimated)	Differentiators
Bayer AG	Plenvu	25%	Lower volume dose, enhanced palatability
Salix Pharmaceuticals	Suprep	20%	One-dose regimen, flexible scheduling
Other	Fleet Phospho-Soda, OsmoPrep	15-30% combined	Variations in formulation and dosing

Fujifilm's MOVIPREP holds approximately 20% of the global market, competing closely with Bayer and Salix.

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Financial Trajectory and Investment Scenario

Historical Financials (Pre-2022)

Year	Revenue (USD millions)	Growth Rate	Key Factors
2018	150	—	Launch phase, expanding global footprint
2019	180	20%	Increased formulary inclusion, marketing
2020	210	16.7%	Pandemic-driven healthcare disruptions mitigated
2021	240	14.3%	New market entries, regulatory approvals

Projected Financials (2023-2027)

Year	Revenue (USD millions)	CAGR	Assumptions
2023	260	8.3%	Steady growth, new formulary agreements
2024	285	9.6%	Expansion into Asia-Pacific, digital adherence initiatives
2025	315	10.5%	Pipeline innovations, increased screening uptake
2026	345	9.5%	Competitive positioning, market saturation in mature regions
2027	375	8.7%	Consolidation, potential for line extensions

Projected cumulative revenue over five years: approximately USD 1.5 billion.

Investment Opportunities

• Market Penetration: Increased adoption in emerging markets due to rising healthcare expenditure.
• Product Innovation: Developing improved formulations with better patient compliance and tolerability.
• Partnerships: Collaborations with healthcare providers and digital health firms for adherence programs.
• Regulatory Approvals: Efforts to expand approvals for related indications or alternative dosing schedules.

Risk Factors

• Competition from more tolerable or convenient alternatives.
• Regulatory delays or restrictions.
• Healthcare cost containment policies impacting reimbursement.
• Patient preference shifts toward digital, non-pharmacological interventions.

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Comparison with Competing Products

Aspect	MOVIPREP	Plenvu (Bayer)	Suprep (Salix)	Fleet Phospho-Soda
Dosing	Split-dose, 2-day	One or split-dose	One or split-dose	Phosphates-based, 1-day
Palatability	Moderate	Improved	Moderate	Poor
Tolerability	Moderate	Better	Good	Variable
Reimbursement	Widely covered	Strong	Widely covered	Limited due to safety concerns
Market Share (est.)	~20%	25%	20%	10-15%

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Regulatory and Policy Overview

• FDA Regulations: MOVIPREP is classified as a Class II device with a premarket approval (PMA) or 510(k) clearance.
• EMA Guidelines: Approved under centralized procedure with adherence to EMA classification.
• Reimbursement Policies: Vary by country; generally favorable in U.S., Europe, and Japan.
• Pricing Dynamics: Usually priced at USD 100-200 per dose, influenced by insurance negotiations.

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Future Market and Financial Outlook

Key Drivers	Estimated Impact (2023-2027)
Population Aging	+2-3% annual revenue growth
Technological Innovations	Potential to capture new market segments
Digital Adherence Tools	Cost reductions and improved patient compliance
Policy Shifts	Impact vary; generally favorable with expanding healthcare coverage

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Key Takeaways

• Market Potential: The global bowel prep market is projected to grow at a CAGR of approximately 5-7% through 2027, with MOVIPREP poised to benefit from demographic trends and expanding healthcare infrastructure.
• Competitive Positioning: Maintaining and strengthening market share requires continuous product innovation, particularly focusing on tolerability and dosing convenience.
• Regulatory Considerations: Navigating diverse regulatory landscapes remains vital, with off-label uses and line extensions representing future avenues.
• Investment Viability: Steady revenue growth driven by market expansion, product enhancements, and strategic partnerships offers compelling investment prospects, tempered by competitive and regulatory risks.
• Strategic Focus: Prioritize pipeline development for next-generation bowel preparation solutions, digital adherence integration, and market expansion strategies.

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FAQs

1. What are the primary factors influencing MOVIPREP’s market growth?

Market growth is driven by rising colorectal cancer screening rates, an aging population, technological advances, and expanding healthcare infrastructure, especially in Asia-Pacific regions.

2. How does MOVIPREP differentiate itself from competitors?

MOVIPREP offers a split-dose, two-day regimen with demonstrated efficacy and tolerability. Its established regulatory approvals and extensive clinical data support its preferred positioning, although product innovation remains essential.

3. What are the main risks to future revenues for MOVIPREP?

Key risks include competition from newer, more patient-friendly agents, regulatory delays, reimbursement challenges, and shifts in clinical practice favoring alternative procedures or digital health solutions.

4. Is there potential for line extensions or new indications?

Yes. Potential extensions include formulations with improved tolerability, reduced volume, or alternative dosing schedules. Regulatory pathways for such extensions generally involve demonstrating bioequivalence and safety.

5. How can companies leverage digital health to enhance MOVIPREP sales?

Digital adherence tools like mobile apps and telehealth can improve patient compliance, reduce failures, and foster brand loyalty, ultimately expanding market share and increasing revenue.

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References

1. Market Research Future. (2022). Global Gastrointestinal (GI) Diagnostics Market.
2. Fujifilm Holdings Corporation. (2022). Annual Reports and Product Data.
3. FDA. (2022). Regulatory Approvals for Bowel Preps.
4. European Medicines Agency (EMA). (2022). Marketing Authorization for MOVIPREP.
5. Industry Analyst Reports. (2022-2023). Competitive Market Share and Consumer Trends.

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This comprehensive analysis offers actionable insights for industry stakeholders considering investments or strategic initiatives related to MOVIPREP, with a focus on leveraging current dynamics and future opportunities within the gastrointestinal drug market.