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Last Updated: January 27, 2023

CLENPIQ Drug Patent Profile


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When do Clenpiq patents expire, and what generic alternatives are available?

Clenpiq is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in ten countries.

The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Clenpiq

There have been two 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.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for CLENPIQ
Drug Prices for CLENPIQ

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Paragraph IV (Patent) Challenges for CLENPIQ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CLENPIQ Oral Solution citric acid; magnesium oxide; sodium picosulfate 10 mg, 3.5 g, and 12 g 209589 1 2019-02-11

US Patents and Regulatory Information for CLENPIQ

CLENPIQ is protected by three US patents.

Patents protecting CLENPIQ

Liquid pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY

Liquid pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CLEANSING THE LARGE INTESTINE AS A PREPARATION FOR COLONOSCOPY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 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 CLENPIQ

When does loss-of-exclusivity occur for CLENPIQ?

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

Australia

Patent: 14386903
Estimated Expiration: See Plans and Pricing

Canada

Patent: 42878
Estimated Expiration: See Plans and Pricing

China

Patent: 6456534
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 20835
Estimated Expiration: See Plans and Pricing

Japan

Patent: 47891
Estimated Expiration: See Plans and Pricing

Patent: 17508815
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6499
Estimated Expiration: See Plans and Pricing

Patent: 16011938
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 68882
Estimated Expiration: See Plans and Pricing

Patent: 16138577
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1420315
Estimated Expiration: See Plans and Pricing

Spain

Patent: 07324
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 CLENPIQ around the world.

Country Patent Number Title Estimated Expiration
Japan 6347891 See Plans and Pricing
Mexico 366499 COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2015141897 See Plans and Pricing
South Korea 101420315 See Plans and Pricing
Japan 2017508815 液状医薬組成物 See Plans and Pricing
Mexico 2016011938 COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.) See Plans and Pricing
European Patent Office 3120835 COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Dow
Colorcon
McKinsey
Express Scripts

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.