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Last Updated: October 7, 2024

PLENVU Drug Patent Profile


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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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-nine 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 three 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

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Summary for PLENVU
Drug patent expirations by year for PLENVU
Drug Prices for PLENVU

See drug prices for PLENVU

Recent Clinical Trials for PLENVU

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

SponsorPhase
Lund UniversityPhase 3
Region SkanePhase 3
Odense University HospitalPhase 3

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 ten US patents.

Patents protecting PLENVU

Compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Colonoscopy-preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Colonoscopy--preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Colon cleansing compositions and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Colonoscopy--preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 2500
Patent: SOLUCION DE LIMPIEZA DE COLON
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 13314442
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷  Sign Up

Patent: 15228962
Patent: Method of cleansing the colon
Estimated Expiration: ⤷  Sign Up

Patent: 18204694
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015005270
Patent: composições compreendendo peg e ascorbato
Estimated Expiration: ⤷  Sign Up

Patent: 2016019914
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 84472
Patent: COMPOSITIONS (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Patent: 42089
Patent: METHODE DE NETTOYAGE DU COLON (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

Patent: 16204
Patent: COMPOSITION POUR NETTOYAGE DU COLON COMPRENANT DE L'ASCORBATE ET DU POLYETHYLENEGLYCOL (PEG) (COLON CLEANSING COMPOSITION COMPRISING ASCORBATE AND PEG)
Estimated Expiration: ⤷  Sign Up

China

Patent: 5007915
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷  Sign Up

Patent: 6102738
Patent: 清洗结肠的方法 (Method of cleansing the colon)
Estimated Expiration: ⤷  Sign Up

Patent: 5154464
Patent: 清洗结肠的方法 (Method of cleaning colon)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191007
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 21668
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 95163
Estimated Expiration: ⤷  Sign Up

Patent: 73248
Estimated Expiration: ⤷  Sign Up

Patent: 77850
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8866
Patent: КОМПОЗИЦИЯ И РАСТВОР ДЛЯ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ, ЛЕКАРСТВЕННОЕ СРЕДСТВО (ВАРИАНТЫ), НАБОР И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (COLON CLEANSING COMPOSITION AND SOLUTION, MEDICAMENT (EMBODIMENTS), KIT AND METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

Patent: 7891
Patent: СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

Patent: 1500320
Patent: КОМПОЗИЦИЯ (ВАРИАНТЫ) И РАСТВОР ДЛЯ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ, ЛЕКАРСТВЕННОЕ СРЕДСТВО, НАБОР И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ)
Estimated Expiration: ⤷  Sign Up

Patent: 1600639
Patent: СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 95163
Patent: COMPOSITIONS COMPRENANT DU PEG ET DE L'ASCORBATE (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Patent: 16494
Patent: MÉTHODE DE NETTOYAGE DU CÔLON (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

Patent: 73248
Patent: COMPOSITIONS COMPRENANT DU POLYÉTHYLÈNE GLYCOL ET UN MÉTAL ALCALIN OU DES SULFATES MÉTALLIQUES ALCALINOTERREUX DESTINÉS À ÊTRE UTILISÉS EN TANT QUE COMPOSITIONS DE NETTOYAGE DU CÔLON (COMPOSITIONS COMPRISING POLYETHYLENE GLYCOL AND ALKALI METAL OR ALKALINE EARTH METAL SULPHATES FOR USE AS COLON CLEANSING COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 77850
Patent: PROCÉDÉ DE NETTOYAGE DU COLON (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 06604
Patent: 含聚乙二醇和抗壞血酸鹽的組合物 (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 43605
Estimated Expiration: ⤷  Sign Up

India

Patent: 04DEN2015
Estimated Expiration: ⤷  Sign Up

Ireland

Patent: 0130273
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷  Sign Up

Patent: 6410
Patent: Compositions comprising PEG and ascorbate
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7377
Patent: הרכבות המכילות peg ו-ascorbate (Compositions comprising peg and ascorbate)
Estimated Expiration: ⤷  Sign Up

Patent: 7170
Patent: שיטה לשטיפת מעי הגס (Method of cleansing the colon)
Estimated Expiration: ⤷  Sign Up

Patent: 9024
Patent: הרכבות המכילות peg ו-ascorbate (Compositions comprising peg and ascorbate)
Estimated Expiration: ⤷  Sign Up

Patent: 4374
Patent: תמיסה לניקוי של מעי הגס (A colon cleansing solution)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 57675
Estimated Expiration: ⤷  Sign Up

Patent: 55391
Estimated Expiration: ⤷  Sign Up

Patent: 77396
Estimated Expiration: ⤷  Sign Up

Patent: 15527385
Patent: PEGとアスコルビン酸塩とを含む組成物
Estimated Expiration: ⤷  Sign Up

Patent: 17507965
Patent: 結腸を洗浄する方法
Estimated Expiration: ⤷  Sign Up

Patent: 20073579
Patent: PEGとアスコルビン酸塩とを含む組成物 (COMPOSITIONS COMPRISING ASCORBATE AND PEG)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 95163
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 4758
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Patent: 8550
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷  Sign Up

Patent: 3378
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 9318
Patent: COMPOSICIONES QUE COMPRENDEN POLIETILENGLICOL Y ASCORBATO. (COMPOSITIONS COMPRISING PEG AND ASCORBATE.)
Estimated Expiration: ⤷  Sign Up

Patent: 15003031
Patent: COMPOSICIONES QUE COMPRENDEN POLIETILENGLICOL Y ASCORBATO. (COMPOSITIONS COMPRISING PEG AND ASCORBATE.)
Estimated Expiration: ⤷  Sign Up

Patent: 16011256
Patent: METODO PARA EL LAVADO DEL COLON. (METHOD OF CLEANSING THE COLON.)
Estimated Expiration: ⤷  Sign Up

Patent: 21005225
Patent: MÉTODO PARA EL LAVADO DEL COLON. (METHOD OF CLEANSING THE COLON.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 413
Patent: KOMPOZICIJE КОЈЕ SADRŽE PEG I ASKORBAT (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 11424
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5499
Patent: Compositions comprising peg and ascorbate
Estimated Expiration: ⤷  Sign Up

Patent: 3017
Patent: Method of cleansing the colon
Estimated Expiration: ⤷  Sign Up

Patent: 3984
Patent: Compositions comprising polyethylene glycol, alkali metal or alkaline earth metal sulphates and electrolytes for use as colon cleansing compositions
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 95163
Estimated Expiration: ⤷  Sign Up

Patent: 73248
Estimated Expiration: ⤷  Sign Up

Patent: 77850
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 95163
Estimated Expiration: ⤷  Sign Up

Patent: 73248
Estimated Expiration: ⤷  Sign Up

Patent: 77850
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 979
Patent: KOMPOZICIJE KOJE SADRŽE PEG I ASKORBAT (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201702005V
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Patent: 201807427R
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷  Sign Up

Patent: 202112138Q
Patent: COMPOSITIONS COMPRISING PEG AND SULPHATE
Estimated Expiration: ⤷  Sign Up

Patent: 201501713X
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Patent: 201606834Q
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 95163
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1501415
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Patent: 1603747
Patent: COMPOSITIONS COMPRISING PEG AND ASCORBATE
Estimated Expiration: ⤷  Sign Up

Patent: 1605592
Patent: METHOD OF CLEANSING THE COLON
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1771586
Estimated Expiration: ⤷  Sign Up

Patent: 2234803
Estimated Expiration: ⤷  Sign Up

Patent: 2257207
Estimated Expiration: ⤷  Sign Up

Patent: 150054990
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Patent: 160130488
Patent: 대장 세척 방법 (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

Patent: 170098980
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Patent: 190137925
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Patent: 210063445
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Patent: 230010844
Patent: PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 28459
Estimated Expiration: ⤷  Sign Up

Patent: 31412
Estimated Expiration: ⤷  Sign Up

Patent: 09386
Estimated Expiration: ⤷  Sign Up

Patent: 28719
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 87238
Estimated Expiration: ⤷  Sign Up

Patent: 56623
Estimated Expiration: ⤷  Sign Up

Patent: 1416092
Patent: Compositions
Estimated Expiration: ⤷  Sign Up

Patent: 2017562
Patent: Compositions, solutions, kits and uses for colon cleansing
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 6546
Patent: РОЗЧИН ДЛЯ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ, КОМПОЗИЦІЯ, НАБІР, ЗАСТОСУВАННЯ КОМПОЗИЦІЇ ДЛЯ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ, ЗАСТОСУВАННЯ РОЗЧИНУ ДЛЯ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ (SB-ACTIN TERMINATOR SEQUENCE FOR GENE EXPRESSION IN PLANTS)
Estimated Expiration: ⤷  Sign Up

Patent: 3659
Patent: СПОСІБ ОЧИЩЕННЯ ТОВСТОЇ КИШКИ (METHOD OF CLEANSING THE COLON)
Estimated Expiration: ⤷  Sign Up

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
Israel 227582 תכשיר לקולונוסקופיה (Colonoscopy-preparation) ⤷  Sign Up
Brazil 112016019914 ⤷  Sign Up
Montenegro 03413 KOMPOZICIJE КОЈЕ SADRŽE PEG I ASKORBAT (COMPOSITIONS COMPRISING PEG AND ASCORBATE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PLENVU

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3141251 C202130017 Spain ⤷  Sign Up 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 122021000018 Germany ⤷  Sign Up 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 301099 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.