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 2019 were $1mm indicating the motivation for generic entry (peak sales were $33mm in 2009).

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for MOVIPREP

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	39
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MOVIPREP
Drug Sales Revenues:	Drug sales revenues 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
Radboud University Medical Center	N/A
Yale University	Phase 4
Assistance Publique - Hôpitaux de Paris	Phase 2

See all MOVIPREP clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MOVIPREP

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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.

Patents protecting 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			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

International Patents for MOVIPREP

When does loss-of-exclusivity occur for MOVIPREP?

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

Australia

Austria

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Africa

Spain

Turkey

United Kingdom

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 MOVIPREP around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	374822	Kompozycje do oczyszczania okrężnicy (COLON CLEANSING COMPOSITIONS)
Cyprus	1113933
Russian Federation	2353412	СУХАЯ КОМПОЗИЦИЯ ДЛЯ СМЕШИВАНИЯ С ВОДОЙ, ОЧИСТИТЕЛЬНЫЙ ПРЕПАРАТ (ВАРИАНТЫ), НАБОР КОМПОНЕНТОВ ДЛЯ ОЧИСТКИ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ), ПОЛИЭТИЛЕНГЛИКОЛЬ В КАЧЕСТВЕ СРЕДСТВА ДЛЯ ОЧИСТКИ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ) И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ) (POWDER/WATER MIXTURE, CLEANING AGENT (VERSIONS), COMPONENT SET FOR LARGE INTESTINE DEPLETION (VERSIONS), POLYETHYLENE GLYCOL AS LARGE INTESTINE DEPLETION AGENT (VERSIONS) AND METHOD OF LARGE INTESTINE DEPLETION (VERSIONS))
China	1705494	Colon cleansing compositions and methods
Japan	2006507281
European Patent Office	1567193	COMPOSITIONS DE NETTOYAGE DU COLON (COLON CLEANSING COMPOSITIONS)
United Kingdom	0224909

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	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	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