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Last Updated: December 15, 2019

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CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - Generic Drug Details

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What are the generic sources for citric acid; magnesium oxide; sodium picosulfate and what is the scope of patent protection?

Citric acid; magnesium oxide; sodium picosulfate is the generic ingredient in two branded drugs marketed by Ferring Pharms Inc and is included in two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Citric acid; magnesium oxide; sodium picosulfate has forty-two patent family members in twenty-four countries.

There are five drug master file entries for citric acid; magnesium oxide; sodium picosulfate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

International Patents:	42
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	5
Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
DailyMed Link:	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE at DailyMed

Recent Clinical Trials for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

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Sponsor	Phase
The Cleveland Clinic	Phase 4
Ferring Pharmaceuticals	Phase 4
Ferring Pharmaceuticals	Phase 3

See all CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE clinical trials

Recent Litigation for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Ferring Pharmaceuticals Inc. v. Novel Laboratories, Inc.	2017-07-05
Ferring Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2017-04-19
Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc.	2015-02-20

See all CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE litigation

Generic filers with tentative approvals for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

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

Paragraph IV (Patent) Challenges for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
CLENPIQ	SOLUTION;ORAL	citric acid; magnesium oxide; sodium picosulfate	209589	2019-02-11
PREPOPIK	FOR SOLUTION;ORAL	citric acid; magnesium oxide; sodium picosulfate	202535	2014-05-21

US Patents and Regulatory Information for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

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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	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	Start Trial	Start Trial	Y			Start Trial
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	Start Trial	Start Trial	Y			Start Trial
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
>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 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

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Country	Patent Number	Estimated Expiration
Croatia	P20180215	Start Trial
Israel	204500	Start Trial
New Zealand	583899	Start Trial
Spain	2659716	Start Trial
World Intellectual Property Organization (WIPO)	2015141897	Start Trial
Portugal	2207526	Start Trial
European Patent Office	3120835	Start Trial
>Country	>Patent Number	>Estimated Expiration

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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 verifification 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.

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