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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-two countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Moviprep

Annual sales in 2021 were $646k (peak sales were $33mm in 2009).

There has been one patent litigation case 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 MOVIPREP

International Patents:	54
US Patents:	2
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
North Denmark Regional Hospital	Phase 4
Aalborg University 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

MOVIPREP 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
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			Y	Y
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			Y	Y

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	7,169,381
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006	7,658,914

International Patents for MOVIPREP

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1567193
World Intellectual Property Organization (WIPO)	2004037292
China	1705494	Colon cleansing compositions and methods
Australia	2008100865	Colon cleansing compositions

Supplementary Protection Certificates for MOVIPREP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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 Experimental

Market Dynamics and Financial Trajectory for Moviprep

Introduction to Moviprep

Moviprep is a bowel preparation drug used to cleanse the colon before procedures such as colonoscopy. It is a polyethylene glycol (PEG)-based solution, known for its effectiveness and relatively fewer side effects compared to other types of bowel preparation drugs.

Market Drivers

Increasing Incidence of Colorectal Diseases

The global market for colonoscopy bowel preparation drugs, including Moviprep, is driven by the rising incidence of colorectal diseases. Colorectal cancer is one of the most common cancers worldwide, and regular colonoscopy screenings are essential for early detection and prevention. According to the World Health Organization, there were over 1.9 million new cases of colorectal cancer and more than 930,000 deaths from the disease in 2020, with projections indicating a significant increase by 2040[4].

Preference for Effective and Less Invasive Methods

There is a growing preference for effective and less invasive bowel preparation methods. Patients and healthcare providers are increasingly opting for PEG-based solutions like Moviprep due to their efficacy and lower side effect profile compared to other types of bowel preparation drugs[3][4].

Technological Advancements

Technological advancements in drug development are also driving the market. Innovations in formulation and delivery methods, such as the development of tablet forms like Sutab, are enhancing patient compliance and comfort, thereby boosting the demand for bowel preparation drugs[4].

Market Trends

Growing Focus on Patient-Friendly Drugs

There is a growing focus on developing patient-friendly bowel preparation drugs. Manufacturers are working to improve the taste, ease of use, and overall patient experience, which is expected to increase the adoption of these drugs[3][4].

Increasing Adoption of Home-Based Preparation Methods

Home-based bowel preparation methods are becoming more popular, reducing the need for hospital visits and making the process more convenient for patients. This trend is expected to continue, driving the demand for drugs like Moviprep[3].

Financial Performance of Moviprep

Revenue Trends

Moviprep has shown consistent revenue performance over the years. For instance, in the third quarter of 2020, Moviprep generated $29 million in revenue, down from $55 million in 2020, but still indicating a stable market presence[2][5].

Market Share and Competition

Moviprep competes in a market dominated by PEG-based drugs. Major players in the market include Takeda Pharmaceutical Company Limited, Ferring Pharmaceuticals, and Salix Pharmaceuticals. These companies are focusing on product innovation, strategic collaborations, and expanding their geographical presence to strengthen their market position[3].

Regional Performance

The market for colonoscopy bowel preparation drugs, including Moviprep, is strongest in North America and Europe due to the high prevalence of colorectal diseases and robust healthcare infrastructure. These regions have favorable reimbursement policies for colonoscopy procedures, which encourages individuals to undergo screenings and boosts the demand for bowel preparation drugs[3][4].

Challenges and Restraints

High Costs and Side Effects

Despite its effectiveness, Moviprep faces challenges such as high costs and potential side effects. The drug can cause metabolic acidosis, particularly high anion gap metabolic acidosis, due to its sulfate content. These side effects can impact patient compliance and overall market growth[1].

Cross-Study Comparisons and Safety Concerns

Studies have shown varying rates of high anion gap and low serum bicarbonate levels in patients using Moviprep compared to other bowel preparation drugs. These differences highlight the need for careful monitoring and management of potential side effects[1].

Future Outlook

Market Growth Projections

The global colonoscopy bowel preparation drugs market, which includes Moviprep, is expected to exhibit a Compound Annual Growth Rate (CAGR) of 4.9% from 2023 to 2030. The market is projected to grow from US$ 2000.5 million in 2023 to US$ 2796.1 million by 2030[4].

Expansion in Emerging Economies

There are significant growth opportunities in emerging economies, where the demand for effective and less invasive bowel preparation methods is increasing. Expanding into these markets could further boost the revenue and market share of Moviprep[3][4].

Key Takeaways

• Moviprep is a PEG-based bowel preparation drug with a high success rate in colon cleansing.
• The market is driven by the increasing incidence of colorectal diseases and the preference for effective and less invasive methods.
• Technological advancements and patient-friendly formulations are key trends.
• Despite high costs and potential side effects, Moviprep remains a significant player in the market.
• The global market is expected to grow at a CAGR of 4.9% from 2023 to 2030.

FAQs

1. What is Moviprep used for?

Moviprep is used to cleanse the colon before procedures such as colonoscopy.

2. What are the key drivers of the Moviprep market?

The key drivers include the increasing incidence of colorectal diseases, preference for effective and less invasive methods, and technological advancements in drug development.

3. What are the potential side effects of Moviprep?

Moviprep can cause high anion gap metabolic acidosis and low serum bicarbonate levels due to its sulfate content.

4. How does Moviprep compare to other bowel preparation drugs?

Moviprep has a high success rate in colon cleansing and is preferred for its efficacy and fewer side effects compared to other types of bowel preparation drugs.

5. What is the projected market growth for Moviprep and similar drugs?

The global colonoscopy bowel preparation drugs market is expected to exhibit a CAGR of 4.9% from 2023 to 2030, reaching US$ 2796.1 million by 2030.

Cited Sources:

1. FDA NDA Summary: "203595Orig1s000 - accessdata.fda.gov"
2. Bausch Health Financial Results: "4Q & FY 2021 - Financial Results - Bausch Health Companies Inc."
3. Colonoscopy Bowel Preparation Drugs Market Analysis: "Colonoscopy Bowel Preparation Drugs Market Size, Forecast"
4. Global Colonoscopy Bowel Preparation Drugs Market: "Global Colonoscopy Bowel Preparation Drugs Market Size, Forecast"
5. Bausch Health Earnings Presentation: "Financial Results - Bausch Health"