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Last Updated: August 11, 2022

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in thirty-six 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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Drug patent expirations by year for PLENVU
Drug Prices for PLENVU

See drug prices for PLENVU

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 nine US patents.

Patents protecting PLENVU

Compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Colonoscopy-preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Colonoscopy--preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Colon cleansing compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Colonoscopy--preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13314442
Estimated Expiration: See Plans and Pricing

Patent: 15228962
Estimated Expiration: See Plans and Pricing

Patent: 18204694
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015005270
Estimated Expiration: See Plans and Pricing

Patent: 2016019914
Estimated Expiration: See Plans and Pricing

Canada

Patent: 84472
Estimated Expiration: See Plans and Pricing

Patent: 42089
Estimated Expiration: See Plans and Pricing

Patent: 16204
Estimated Expiration: See Plans and Pricing

China

Patent: 5007915
Estimated Expiration: See Plans and Pricing

Patent: 6102738
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0191007
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 95163
Estimated Expiration: See Plans and Pricing

Patent: 73248
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8866
Estimated Expiration: See Plans and Pricing

Patent: 7891
Estimated Expiration: See Plans and Pricing

Patent: 1500320
Estimated Expiration: See Plans and Pricing

Patent: 1600639
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 95163
Estimated Expiration: See Plans and Pricing

Patent: 16494
Estimated Expiration: See Plans and Pricing

Patent: 73248
Estimated Expiration: See Plans and Pricing

Patent: 77850
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 06604
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 43605
Estimated Expiration: See Plans and Pricing

India

Patent: 04DEN2015
Estimated Expiration: See Plans and Pricing

Ireland

Patent: 0130273
Estimated Expiration: See Plans and Pricing

Patent: 6410
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7377
Estimated Expiration: See Plans and Pricing

Patent: 7170
Estimated Expiration: See Plans and Pricing

Patent: 9024
Estimated Expiration: See Plans and Pricing

Patent: 4374
Estimated Expiration: See Plans and Pricing

Japan

Patent: 57675
Estimated Expiration: See Plans and Pricing

Patent: 55391
Estimated Expiration: See Plans and Pricing

Patent: 15527385
Estimated Expiration: See Plans and Pricing

Patent: 17507965
Estimated Expiration: See Plans and Pricing

Patent: 20073579
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 95163
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4758
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9318
Estimated Expiration: See Plans and Pricing

Patent: 15003031
Estimated Expiration: See Plans and Pricing

Patent: 16011256
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 413
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 11424
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5499
Estimated Expiration: See Plans and Pricing

Patent: 3984
Estimated Expiration: See Plans and Pricing

Poland

Patent: 95163
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 95163
Estimated Expiration: See Plans and Pricing

Patent: 73248
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 979
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201702005V
Estimated Expiration: See Plans and Pricing

Patent: 201807427R
Estimated Expiration: See Plans and Pricing

Patent: 202112138Q
Estimated Expiration: See Plans and Pricing

Patent: 201501713X
Estimated Expiration: See Plans and Pricing

Patent: 201606834Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 95163
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1501415
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1771586
Estimated Expiration: See Plans and Pricing

Patent: 2234803
Estimated Expiration: See Plans and Pricing

Patent: 2257207
Estimated Expiration: See Plans and Pricing

Patent: 150054990
Estimated Expiration: See Plans and Pricing

Patent: 160130488
Estimated Expiration: See Plans and Pricing

Patent: 170098980
Estimated Expiration: See Plans and Pricing

Patent: 190137925
Estimated Expiration: See Plans and Pricing

Patent: 210063445
Estimated Expiration: See Plans and Pricing

Spain

Patent: 28459
Estimated Expiration: See Plans and Pricing

Patent: 31412
Estimated Expiration: See Plans and Pricing

Patent: 09386
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 87238
Estimated Expiration: See Plans and Pricing

Patent: 56623
Estimated Expiration: See Plans and Pricing

Patent: 1416092
Estimated Expiration: See Plans and Pricing

Patent: 2017562
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 6546
Estimated Expiration: See Plans and Pricing

Patent: 3659
Estimated Expiration: See Plans and Pricing

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
Australia 2015228962 Method of cleansing the colon See Plans and Pricing
South Korea 20190137925 PEG 및 아스코르베이트를 포함하는 조성물 (PEG COMPOSITIONS COMPRISING PEG AND ASCORBATE) See Plans and Pricing
Japan 2017507965 結腸を洗浄する方法 See Plans and Pricing
Hong Kong 1188115 結腸清洗組合物 (COLON CLEANSING COMPOSITIONS) See Plans and Pricing
European Patent Office 2895163 COMPOSITIONS COMPRENANT DU PEG ET DE L'ASCORBATE (COMPOSITIONS COMPRISING PEG AND ASCORBATE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PLENVU

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3141251 132021000000044 Italy See Plans and Pricing 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 See Plans and Pricing 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 122021000018 Germany See Plans and Pricing 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 C202130017 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Express Scripts
Mallinckrodt
Merck
McKesson

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.