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

What are the generic drug 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 three branded drugs marketed by Ferring Pharms Inc and Hetero Labs Ltd V, and is included in three NDAs. There are five 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-five patent family members in twenty-five countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

International Patents:	45
US Patents:	5
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	6
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

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

Sponsor	Phase
Norgine	Phase 4
Aalborg University Hospital	Phase 4
North Denmark Regional Hospital	Phase 4

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

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

Applicant	Application No.	Strength	Dosage Form
		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	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

Anatomical Therapeutic Chemical (ATC) Classes for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

A02AA	Magnesium compounds
A02A	ANTACIDS
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A06AB	Contact laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A09AB	Acid preparations
A09A	DIGESTIVES, INCL. ENZYMES
A09	DIGESTIVES, INCL. ENZYMES
A	Alimentary tract and metabolism

A12CC	Magnesium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

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

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
PREPOPIK	Oral Solution	citric acid; magnesium oxide; sodium picosulfate	10 mg, 3.5 g, and 12 g	202535	1	2014-05-21

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	212789-001	Jul 18, 2022		RX	No	Yes
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No			Y

International Patents for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Country	Patent Number	Title	Estimated Expiration
Jordan	3406	عملية لتصنيع منتج صيدلاني يشتمل على حمض الستريك ،أكسيد ماغنسيوم، بيكربونات بوتاسيوم وبيكو كبريتات صوديوم، تركيبة صيدلانية تشتمل على حبيبات متحصل عليها بواسطة هذه العملية ومنتجات وسيطة منها (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF)
European Patent Office	2207526	PROCÉDÉ DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE CONTENANT DE L'ACIDE CITRIQUE, DE L'OXYDE DE MAGNÉSIUM, DU BICARBONATE DE POTASSIUM ET DU PICOSULFATE DE SODIUM, COMPOSITION PHARMACEUTIQUE CONTENANT DES GRANULES ET LEUR PRODUIT INTERMEDIAIRE (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF)
European Patent Office	3120835	COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)