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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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Summary for CLENPIQ

International Patents:	13
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CLENPIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLENPIQ
What excipients (inactive ingredients) are in CLENPIQ?	CLENPIQ excipients list
DailyMed Link:	CLENPIQ at DailyMed

Drug patent expirations by year for CLENPIQ

Recent Clinical Trials for CLENPIQ

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

Sponsor	Phase
Ferring Pharmaceuticals	Phase 1/Phase 2
The Cleveland Clinic	Phase 4
Ferring Pharmaceuticals	Phase 4

See all CLENPIQ clinical trials

Pharmacology for CLENPIQ

Drug Class	Anti-coagulant Calculi Dissolution Agent Osmotic Laxative Stimulant Laxative
Mechanism of Action	Acidifying Activity Calcium Chelating Activity Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Decreased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Liquid pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY

Liquid pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CLEANSING THE LARGE INTESTINE AS A PREPARATION FOR COLONOSCOPY

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		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 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
Patent: Liquid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 42878
Patent: COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up

China

Patent: 6456534
Patent: 液体药物组合物 (Liquid pharmaceutical composition)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 20835
Patent: COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 47891
Estimated Expiration: ⤷ Sign Up

Patent: 17508815
Patent: 液状医薬組成物
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 6499
Patent: COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up

Patent: 16011938
Patent: COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 68882
Patent: Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up

Patent: 16138577
Patent: Жидкая фармцевтическая композиция
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1420315
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 07324
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 CLENPIQ around the world.

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Country	Patent Number	Title	Estimated Expiration
China	106456534	液体药物组合物 (Liquid pharmaceutical composition)	⤷ Sign Up
Japan	2017508815	液状医薬組成物	⤷ Sign Up
Spain	2907324		⤷ Sign Up
Russian Federation	2668882	Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION)	⤷ Sign Up
Australia	2014386903	Liquid pharmaceutical composition	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration