Citric acid; magnesium oxide; sodium picosulfate - Generic Drug Details

What are the generic sources for citric acid; magnesium oxide; sodium picosulfate and what is the scope of freedom to operate?

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
North Denmark Regional Hospital	Phase 4
Norgine	Phase 4
Aalborg University 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
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	9,827,231		Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	11,191,753
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,450,338		Y
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	10,624,879		Y

International Patents for citric acid; magnesium oxide; sodium picosulfate

Country	Patent Number	Title	Estimated Expiration
Mexico	366499	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)
Taiwan	I418352
Portugal	2207526
Slovenia	2207526
Mexico	2016011938	COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.)

Citric acid; magnesium oxide; sodium picosulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Introduction

The combination of citric acid, magnesium oxide, and sodium picosulfate is a potent formulation used for colon cleansing prior to colonoscopy. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting its approval, usage, and economic impact.

Approval and Regulatory Landscape

The drug combination, marketed under names such as Prepopik and Clenpiq, was approved by the FDA in 2012 for adults and later extended to pediatric patients aged 9 years and older[2][3].

• Prepopik: Approved in 2012 for adults, it is a powder for oral solution containing sodium picosulfate, magnesium oxide, and anhydrous citric acid. It has since been approved for pediatric use as well[2].
• Clenpiq: A pre-mixed, ready-to-drink oral solution with the same active ingredients, approved in 2017 based on the safety and efficacy data of Prepopik[3].

Market Indication and Usage

This drug combination is specifically indicated for the cleansing of the colon as a preparation for colonoscopy.

• Mechanism of Action: Sodium picosulfate acts as a stimulant laxative by inhibiting water absorption in the colon, while magnesium citrate, formed by the combination of magnesium oxide and citric acid, acts as an osmotic laxative, retaining fluids in the colon[1][3].
• Dosing Regimens: The preferred dosing regimen is the split-dose method, where two doses are taken at separate times, which has been shown to enhance efficacy compared to traditional dosing[5].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of this drug combination.

• Split-Dose Regimen: Studies have shown that the split-dose regimen significantly improves bowel cleansing efficacy, particularly in the right-sided colon, without compromising tolerability and safety[5].
• Pediatric Use: Clinical trials in pediatric patients aged 9-16 years have shown that Prepopik is effective and well-tolerated, performing similarly to polyethylene glycol (PEG) solutions[2].

Market Demand and Growth

The demand for effective colon cleansing agents is driven by the increasing need for colonoscopies due to rising incidence of colorectal cancer and other gastrointestinal disorders.

• Global Market: The drug is marketed in over 38 countries, including the United States, the United Kingdom, Ireland, and Canada, indicating a broad market reach[1].
• Competitive Landscape: The market for colon cleansing agents is competitive, with other products like PEG solutions. However, the convenience and efficacy of the split-dose regimen of Prepopik and Clenpiq have helped these products gain a significant market share[5].

Financial Performance

The financial performance of these drugs is influenced by several factors, including market demand, pricing strategies, and competition.

• Revenue Growth: The approval and subsequent marketing of Prepopik and Clenpiq have contributed to significant revenue growth for Ferring Pharmaceuticals. The extension of the indication to pediatric patients has further expanded the market potential[2][3].
• Pricing Strategies: The pricing of these drugs is competitive with other colon cleansing agents. The convenience of the pre-mixed Clenpiq solution may justify a premium pricing strategy, contributing to higher revenue per unit[3].

Challenges and Opportunities

Despite the successes, there are challenges and opportunities in the market.

• Compliance and Adherence: Ensuring patient compliance with the dosing regimen is crucial. Educational programs and patient support materials can help improve adherence and thus the overall efficacy of the treatment[5].
• Innovation and Expansion: Continuous innovation, such as the development of new formulations or dosing regimens, can help maintain market leadership. Expanding indications to other gastrointestinal procedures could also increase market share[3].

Key Players and Partnerships

Ferring Pharmaceuticals is the primary player in the market for this drug combination.

• Ferring Pharmaceuticals: As the manufacturer and marketer of Prepopik and Clenpiq, Ferring Pharmaceuticals has a strong presence in the gastrointestinal health market. Partnerships with healthcare providers and patient advocacy groups can further strengthen their market position[2][3].

Future Outlook

The future outlook for this drug combination is positive, driven by increasing demand for effective and convenient colon cleansing solutions.

• Technological Advancements: Advances in formulation technology could lead to more patient-friendly products, further enhancing market demand.
• Regulatory Environment: Continued regulatory approvals and extensions of indications will be crucial for maintaining and expanding market share[3].

Key Takeaways

• The combination of citric acid, magnesium oxide, and sodium picosulfate is a highly effective and well-tolerated colon cleansing agent.
• Approved for both adults and pediatric patients, it offers a broad market potential.
• The split-dose regimen enhances efficacy and patient compliance.
• Ferring Pharmaceuticals is a key player, with significant revenue growth potential.
• Continuous innovation and strategic partnerships are essential for maintaining market leadership.

Frequently Asked Questions

Q: What is the primary indication for the drug combination of citric acid, magnesium oxide, and sodium picosulfate?

A: The primary indication is for the cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients aged 9 years and older.

Q: What is the mechanism of action of this drug combination?

A: Sodium picosulfate acts as a stimulant laxative, while magnesium citrate, formed by magnesium oxide and citric acid, acts as an osmotic laxative.

Q: What is the preferred dosing regimen for this drug combination?

A: The split-dose regimen is preferred, where two doses are taken at separate times, which enhances efficacy.

Q: Is this drug combination safe and effective in pediatric patients?

A: Yes, clinical trials have shown that it is safe and effective in pediatric patients aged 9-16 years.

Q: Who is the primary manufacturer and marketer of this drug combination?

A: Ferring Pharmaceuticals is the primary manufacturer and marketer of Prepopik and Clenpiq.

Cited Sources:

1. FDA Memorandum: PrepoPik (sodium picosulfate, magnesium oxide and anhydrous citric acid) powder for oral solution[1].
2. FDA Clinical Review: Prepopik™ (Citric Acid, Magnesium Oxide, and Sodium Picosulfate) Powder for Oral Solution[2].
3. FDA Clinical Review: Clenpiq™ (sodium picosulfate, magnesium oxide and citric acid) pre-mixed oral solution[3].
4. DrugBank: Magnesium oxide: Uses, Interactions, Mechanism of Action[4].
5. PubMed: Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy[5].