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 six 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-eight patent family members in twenty-six countries.

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:	48
US Patents:	6
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
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
Hitit University	PHASE4
Fu Jen Catholic University Hospital	NA
Norgine	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	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No			Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes			Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes
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

International Patents for citric acid; magnesium oxide; sodium picosulfate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2668882	Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION)
Russian Federation	2010112483	СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ
Denmark	2207526
Taiwan	I418352

Market Dynamics and Financial Trajectory for Citric Acid, Magnesium Oxide, and Sodium Picosulfate

Last updated: July 27, 2025

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Introduction

The global pharmaceutical and nutraceutical sectors continue to evolve driven by increasing healthcare awareness, regulatory shifts, and technological advancements. Within this landscape, key compounds such as citric acid, magnesium oxide, and sodium picosulfate play essential roles, spanning applications from pharmaceuticals and dietary supplements to industrial uses. This analysis elucidates current market dynamics and projects the financial trajectories for these compounds, providing strategic insights for stakeholders aiming to navigate this complex environment.

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Market Overview

Citric Acid

Citric acid remains one of the most widely used organic acids in pharmaceutical formulations, food and beverage industries, and industrial cleaning agents. Its natural origin, safety profile, and multifunctionality position it favorably amidst rising health-conscious consumer trends.

The global market for citric acid is projected to reach approximately USD 4.2 billion by 2027, growing at a CAGR of 5.1% from 2022 to 2027 (Allied Market Research, 2022). Key drivers include increased demand from the food and beverage segment—especially in functional foods and non-dairy beverages—and rising adoption in pharmaceuticals to improve stability and taste.

Magnesium Oxide

Magnesium oxide’s primary applications encompass pharmaceutical supplements, antacids, refractory materials, and environmental remediation. The increasing prevalence of magnesium deficiency-related health conditions, particularly in aging populations, sustains demand growth.

Projected to expand at a CAGR of 4.3% through 2027, the magnesium oxide market is expected to approach USD 2.8 billion (Research and Markets, 2022). A surge in demand from the nutraceutical sector, combined with expanding industrial applications in steel manufacturing and environmental applications, underpins this trajectory.

Sodium Picosulfate

Sodium picosulfate serves as a stimulant laxative, widely used in bowel cleansing preparations for medical procedures and at-home constipation management. The increasing incidence of gastrointestinal disorders and the healthcare shift towards outpatient and minimally invasive procedures fuel demand.

The global sodium picosulfate market is anticipated to grow at a CAGR of 4.8%, reaching USD 240 million by 2027 (Fortune Business Insights, 2022). Growing aging populations and the demand for OTC laxatives in emerging markets notably influence this growth.

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Market Dynamics

Drivers

• Rising Healthcare Awareness: Increasing prevalence of chronic and gastrointestinal disorders propels demand for products containing sodium picosulfate, magnesium oxide, and citric acid.

• Aging Population: Older demographics worldwide are contributing to higher consumption of pharmaceutical and dietary supplement products requiring these compounds.

• Technological Innovations: Advances in extraction, biosynthesis, and manufacturing processes enhance purity, reduce costs, and open new application avenues.

• Regulatory Environment: Regulatory approvals and standards (e.g., FDA, EMA) for pharmaceuticals and food-grade applications bolster market confidence, though they also pose compliance challenges.

• Consumer Shift to Natural and Clean-label Products: Growing preference for natural acids like citric acid aligns with trends toward organic and clean-label formulations.

Challenges

• Supply Chain Disruptions: Fluctuations in raw material availability, geopolitical tensions, and pandemic-driven supply chain issues impact production stability.

• Regulatory Hurdles: Stringent standards for pharmaceutical-grade compounds necessitate significant investment in compliance.

• Price Volatility: Raw material price fluctuations, especially in citric acid derived from fermentation, influence profitability.

• Environmental Concerns: Production processes, particularly for magnesium oxide and citric acid, face scrutiny regarding sustainability and waste management.

Competitive Landscape

The market features key players like Cargill, Archer Daniels Midland Company, and Jungbunzlauer. Innovations such as bio-based production methods and specialty formulations provide competitive edges. Vertical integration and strategic partnerships are common strategies for market expansion.

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Financial Trajectory and Investment Outlook

Revenue Projections

• Citric Acid: Anticipated to grow from approximately USD 3.4 billion in 2022 to USD 4.2 billion in 2027, driven chiefly by food industry expansion and pharmaceutical utilization. Emerging markets are expected to contribute disproportionately to growth.

• Magnesium Oxide: Expected to increase from USD 2 billion in 2022 to USD 2.8 billion in 2027, with significant gains stemming from nutraceutical segment growth and industrial applications.

• Sodium Picosulfate: Predicted to rise from USD 160 million in 2022 to USD 240 million in 2027, reflecting rising demand for OTC and prescription gastrointestinal medications.

Profitability and Investment Opportunities

• R&D Focus: Investment in sustainable, bio-based production techniques for citric acid and magnesium oxide offers margins expansion potential.

• Regulatory Certification: Achieving compliance with international standards (e.g., GMP, ISO) enhances global market access and premium pricing.

• Emerging Markets: Expanding healthcare infrastructure and increasing health awareness in Asia-Pacific and Latin America present lucrative opportunities.

Risks and Mitigation

• Raw Material Dependence: Diversifying sourcing and investing in vertical integration mitigate raw material risks.

• Regulatory Changes: Proactive adaptation to evolving standards prevents market access disruptions.

• Market Saturation: Continuous innovation and lifecycle extension strategies are vital to sustain competitive advantage.

Conclusion

The markets for citric acid, magnesium oxide, and sodium picosulfate exhibit robust growth trajectories driven by demographic shifts, technological advancements, and evolving consumer preferences. Strategic investments in sustainability, compliance, and product differentiation will be critical to capitalizing on emerging opportunities.

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Key Takeaways

• The cumulative growth of these compounds aligns with broader healthcare and industrial trends, with the combined market size reaching over USD 7 billion by 2027.
• Innovation in green manufacturing processes will serve as a key differentiator and profitability enhancer.
• Asia-Pacific emerges as a central growth hub, driven by increasing healthcare infrastructure and consumer demand.
• Policymakers and industry stakeholders should monitor regulatory developments closely to align product offerings with international standards.
• Diversification of supply chains and investment in R&D will mitigate risks associated with raw material volatility and regulatory hurdles.

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FAQs

1. What are the primary applications of citric acid in pharmaceuticals?
Citric acid is used as an excipient for pH regulation, stabilizer, and flavor enhancer in oral and injectable medications, alongside applications in lyophilized formulations and effervescent tablets.

2. How is magnesium oxide typically produced for pharmaceutical use?
Manufacturers often produce magnesium oxide via calcination of magnesium carbonate or magnesium hydroxide derived from natural mineral sources or seawater, emphasizing purity and particle size control tailored for bioavailability.

3. What factors influence the pricing of sodium picosulfate?
Pricing is affected by raw material costs, manufacturing scale, regulatory compliance, and competition. Patent status and market demand for gastrointestinal products also impact price stability.

4. Which geographical markets are emerging as significant for these compounds?
Emerging markets in Asia-Pacific, Latin America, and Africa are experiencing rapid demand growth due to expanding healthcare infrastructure and rising consumer health awareness.

5. What sustainable practices are adopted in the production of these chemicals?
Adoption of bio-based fermentation for citric acid, waste minimization strategies, energy-efficient calcination processes, and wastewater treatment are key sustainable practices gaining industry traction.

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References

[1] Allied Market Research, "Citric Acid Market to Reach USD 4.2 Billion by 2027," 2022.
[2] Research and Markets, "Magnesium Oxide Market Forecast to 2027," 2022.
[3] Fortune Business Insights, "Sodium Picosulfate Market Growth," 2022.