MOVIPREP Drug Patent Profile

When do Moviprep patents expire, 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
Finished Product Suppliers / Packagers:	2
Clinical Trials:	40
Drug Prices:	Drug price information for MOVIPREP
Drug Sales Revenues:	Drug sales revenues for MOVIPREP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVIPREP
What excipients (inactive ingredients) are in MOVIPREP?	MOVIPREP excipients list
DailyMed Link:	MOVIPREP at DailyMed

See drug prices for MOVIPREP

See drug sales revenues for MOVIPREP

Recent Clinical Trials for MOVIPREP

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

Sponsor	Phase
Aalborg University Hospital	Phase 4
North Denmark Regional Hospital	Phase 4
Radboud University Medical Center	N/A

See all MOVIPREP clinical trials

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

Expired US Patents for MOVIPREP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent 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
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006

International Patents for MOVIPREP

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2014304
Slovenia	2314319
South Africa	200503247	Colon cleansing compositions.
Cyprus	1113933
Japan	5660320

Supplementary Protection Certificates for MOVIPREP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

MOVIPREP Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics of Moviprep?

Moviprep, a laxative used for bowel preparation before colonoscopy, is manufactured primarily by Takeda Pharmaceuticals. The drug's market depends on several factors, including shifts in healthcare practices, patient preferences, and competitive landscape.

Market Size and Demand Drivers

The global colonoscopy preparation market was valued at approximately USD 850 million in 2022, with Moviprep capturing around 20-25% of this segment globally. Growth drivers include:

• Increase in colorectal cancer screening programs.
• Rising incidence of gastrointestinal disorders.
• Aging populations in North America, Europe, and parts of Asia.

In North America, the market demand for bowel cleansing agents is projected to grow at a Compound Annual Growth Rate (CAGR) of 4-6% through 2027, driven by policy recommendations endorsing routine screenings.

Competitive Landscape

Moviprep faces competition from generic formulations and other proprietary products like MiraLAX, Suprep, and Fleet Phospho-Soda. Brand loyalty, efficacy, safety profiles, and dosing convenience influence market share.

Regulatory and Reimbursement Trends

U.S. Food and Drug Administration (FDA) approval processes influence market entry and expansion. Reimbursement policies by Medicare, Medicaid, and private insurers impact patient access and drug sales. Moviprep's inclusion in hospital formularies and insurance reimbursement rates shapes revenue streams.

How Has the Financial Trajectory Evolved?

Revenue Trends

Takeda reported global sales of bowel preparation products at approximately USD 250 million in fiscal year 2022, with Moviprep accounting for nearly 80% of this figure. Revenue growth has been steady, with an annual increase of about 3-4% over the past five years.

Pricing and Market Penetration

Pricing strategies vary across regions; in the U.S., Moviprep typically retails for USD 80–USD 150 per cycle, depending on insurance coverage. Markets with higher adoption rates correspond to higher revenues. Market penetration has increased in Asia-Pacific with expanding healthcare infrastructure, reaching approximately 15% of the bowel prep market there by 2022.

Patent and Regulatory Status

Moviprep’s primary patent protections expired in 2019, allowing generics to enter the market. However, Takeda maintains exclusivity through regulatory and distribution agreements in certain regions. Patent expirations have led to increased competition, pressure on pricing, and volume-driven growth.

R&D and Pipeline Outlook

Limited pipeline developments are linked to existing formulations, with R&D focusing on improved formulations and alternative delivery methods. The absence of significant pipeline innovations constrains future revenue growth.

How Do Market Trends Impact Future Financial Outlook?

The CAGR for the bowel preparation segment is expected to be 4-6%, translating to potential revenue growth for Moviprep within the established market. Price erosion due to generic competition may offset volume gains, emphasizing the reliance on region-specific adoption rates.

In markets with expanding healthcare access and increased screening, revenue growth may accelerate. Conversely, regulatory constraints or shifts toward alternative preparation methods could dampen growth.

Summary of Key Financial Metrics

Metric	2022	2021	Growth Rate
Global bowel prep market revenue	USD 850 million	USD 800 million	6.25%
Moviprep global sales	USD 250 million	USD 240 million	4.17%
Moviprep market share in bowel prep	~20-25%	~25%	Slight decline due to generic competition
Revenue contribution to Takeda (all products)	~2%	~2%	Stable

Key Takeaways

• Demand for Moviprep is driven by increasing colorectal screening and gastrointestinal disorder prevalence.
• Market growth is steady but faces headwinds from patent expirations and generics.
• Pricing pressures influence revenue, with variations across regions.
• Future revenue hinges on regional adoption, regulatory environment, and competitive dynamics.
• Limited pipeline innovation constrains long-term growth prospects.

FAQs

1. How does patent expiry influence Moviprep’s market share?
Patent expirations in 2019 allowed generics to enter, increasing competition and exerting downward pressure on prices, leading to a decline in exclusive revenues for Takeda.

2. What regions offer the most growth potential for Moviprep?
Asia-Pacific and Latin America are expanding markets driven by increased healthcare infrastructure and screening initiatives.

3. How do reimbursement policies affect Moviprep sales?
Coverage by insurance providers and national health plans determine patient affordability and access, directly impacting sales volumes.

4. Are there any recent regulatory changes affecting Moviprep?
No recent major regulatory hurdles; however, ongoing reviews in certain markets may influence uptake and formulary inclusion.

5. What is the outlook for generic competition?
Post-patent expiry, generic formulations are likely to capture significant market share, pressuring brand-name revenues unless differentiation strategies are implemented.

References

[1] MarketWatch. "Colonoscopy Preparation Market Size, Share & Trends." 2022.
[2] Takeda Pharmaceuticals Annual Report, FY 2022.
[3] IQVIA. "Global GI Medications and Procedures Report," 2022.