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Last Updated: March 19, 2026

citric acid; magnesium oxide; sodium picosulfate - Profile


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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 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.

There is one tentative approval for this compound.

Summary for citric acid; magnesium oxide; sodium picosulfate
Generic filers with tentative approvals for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Applicant Application No. Strength Dosage Form
⤷  Get Started Free⤷  Get Started Free12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR 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.

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 ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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

Country Patent Number Title Estimated Expiration
Israel 204500 תהליך לייצור הרכב או הרכב רוקחי על ידי ריסוס ציפוי של שכבת נתרן פיקוסולפאט על גרעין של אשלגן ביקרבונאט (Process for the manufacture of a composition or pharmaceutical composition comprising spray coating a layer of sodium picosulphate on a core of potassium bicarbonate) ⤷  Get Started Free
Russian Federation 2668882 Жидкая фармацевтическая композиция (LIQUID PHARMACEUTICAL COMPOSITION) ⤷  Get Started Free
Croatia P20180215 ⤷  Get Started Free
Japan 2017508815 液状医薬組成物 ⤷  Get Started Free
Mexico 366499 COMPOSICION FARMACEUTICA LIQUIDA. (LIQUID PHARMACEUTICAL COMPOSITION.) ⤷  Get Started Free
South Korea 101420315 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

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

Last updated: February 3, 2026


Summary

This report assesses the investment outlook, market dynamics, and financial forecasts for three pharmaceutical and nutraceutical compounds: citric acid, magnesium oxide, and sodium picosulfate. The evaluation considers global demand trends, supply chain factors, regulatory landscapes, and competitive positions. Historically, these compounds have stable demand due to their extensive usage in pharmaceuticals, food industry, and supplements.


1. Market Overview

Compound Primary Uses Key Industries Estimated Global Market Size (2023) CAGR (2023–2028) Major Regions
Citric Acid Food additive, pharmaceuticals, cosmetics Food, beverages, pharma, cosmetics ~$3.5 billion 4.7% Asia-Pacific, North America, Europe
Magnesium Oxide Antacid, supplement, industrial applications Healthcare, construction, pharma ~$1.2 billion 3.2% Asia-Pacific, Europe, North America
Sodium Picosulfate Laxative, pharmaceutical formulation Pharmaceuticals ~$0.4 billion 5.0% North America, Europe, Asia-Pacific

2. Investment Drivers and Market Dynamics

What are the key drivers influencing these markets?

Compound Key Drivers Underlying Factors
Citric Acid Growing food and beverage industry, pharmaceutical applications Rising demand for organic acids, food preservation, manufacturing growth
Magnesium Oxide Increasing demand for antacids, nutritional supplements Aging population, lifestyle diseases, dietary supplement trends
Sodium Picosulfate Consumer demand for OTC laxatives, pharmaceutical innovation Stringent regulations favoring established products, patent expirations

What are the supply chain and raw material considerations?

Compound Raw Materials Supply Chain Risks Price Volatility Factors
Citric Acid Corn/corn derivatives, fermentation substrates Agricultural dependency, commodity price fluctuations Climate change impacts, energy costs
Magnesium Oxide Magnesite mineral, calcination process Mining regulations, energy-intensive manufacturing Ore availability, environmental regulations
Sodium Picosulfate Chemical synthesis precursors Procurement of specialty chemicals, regulatory barriers Raw chemical prices, processing complexity

3. Financial Trajectory and Investment Outlook

Projected Revenue Growth and Profitability

Compound 2023 Estimated Revenue 2028 Forecasted Revenue CAGR (2023–2028) Major Growth Factors
Citric Acid ~$3.5 billion ~$4.5 billion 4.7% Food industry expansion, pharmaceutical niche growth
Magnesium Oxide ~$1.2 billion ~$1.55 billion 3.2% Aging populations, health supplement demand
Sodium Picosulfate ~$0.4 billion ~$0.53 billion 5.0% Patent expiration, OTC market expansion, new formulations

Profitability Margins and Investment Risks

Compound Typical Profit Margin (%) Major Risks
Citric Acid 10–15% Raw material price swings, regulatory fluctuations
Magnesium Oxide 12–18% Environmental regulations, supply constraints
Sodium Picosulfate 20–30% Patent litigation, regulatory hurdles

Investment Opportunities and Challenges

Opportunities Challenges
Expansion into emerging markets, bio-fermentation innovations Commodity price volatility, supply chain disruptions
R&D for novel formulations, eco-friendly synthesis methods Regulatory compliance, patent expirations
Vertical integration for raw material control Environmental compliance costs

4. Competitive Landscape

Key Players Market Share (%) Strategic Moves Recent Innovations
Archer Daniels Midland (ADM) 20% Diversification into bio-fermentation platforms Eco-friendly citric acid production
Sigma-Aldrich (Merck) 15% Focus on pharmaceutical-grade excipients Customized formulations for pharma markets
Prayon Group 10% Strengthening food additive and pharmaceutical segments Bio-fermentation processes
Others 55% Fragmented sector with regional niche players M&A activity, sustainable production methods

5. Regulatory and Policy Factors

  • FDA and EMA Regulations: Stringent quality and safety standards impact production costs and market entry.
  • Environmental Policies: Growing emphasis on sustainability influences manufacturing practices.
  • Patent & Exclusivity Periods: Patent expirations create opportunities for generics and biosimilar entrants.
  • Import/Export Tariffs: Affect global supply chains, particularly in Asia-Pacific and Europe.

6. Comparative Analysis

Metric Citric Acid Magnesium Oxide Sodium Picosulfate
Market Size (2023) ~$3.5 billion ~$1.2 billion ~$0.4 billion
CAGR (2023–2028) 4.7% 3.2% 5.0%
Profit Margin Range 10–15% 12–18% 20–30%
Market Key Regions Asia-Pacific, NA, EU Asia-Pacific, EU, NA North America, EU, Asia-Pac
R&D Intensity Moderate Moderate High

7. Market Outlook and Investment Strategy

Timeline Market Trends & Strategic Focus Recommendations
Short-term (1–2 years) Regulatory stabilization, supply chain optimization Invest in established manufacturers, focus on quality control
Mid-term (3–5 years) Innovation in sustainable processes, regional expansion R&D efforts, consider vertical integration
Long-term (5+ years) Growing global demand, health and wellness trends Diversification into derivatives, bio-based approaches

8. Key Takeaways

  • The market for citric acid, magnesium oxide, and sodium picosulfate is characterized by moderate growth, driven by food, pharmaceutical, and nutraceutical demand.
  • Investment opportunities arise from regional expansion, R&D innovation, and sustainable manufacturing practices.
  • Risks include raw material price volatility, regulatory hurdles, and supply chain disruptions.
  • Profit margins remain attractive in sodium picosulfate due to high medicinal value and patent protection, while citric acid's margins are more sensitive to commodity prices.
  • The long-term outlook favors companies focusing on eco-friendly production, bio-based innovations, and strategic diversification.

References

  1. MarketsandMarkets, “Citric Acid Market by Application and Region,” 2023.
  2. Grand View Research, “Magnesium Oxide Market Size & Share,” 2023.
  3. Research and Markets, “Sodium Picosulfate Market Analysis,” 2023.
  4. U.S. Food and Drug Administration (FDA), “Regulatory Guidelines,” 2023.
  5. European Medicines Agency (EMA), “Pharmaceutical Regulations,” 2023.

FAQs

Q1: What factors most influence the raw material prices for these compounds?
Raw material prices are mainly affected by agricultural yields (for citric acid), mineral ore availability (magnesium oxide), and chemical precursor costs (sodium picosulfate). Climate change, mining regulations, and energy costs are major drivers.

Q2: How do patent expirations impact sodium picosulfate’s market?
Patent expirations open markets to generic manufacturers, increasing competition but also creating opportunities for more affordable formulations, which can stimulate market growth.

Q3: Which geographic region offers the most promising investment opportunities?
Asia-Pacific presents significant growth potential due to expanding manufacturing capacity, increasing demand in food and pharma sectors, and favorable regulatory environments.

Q4: Are sustainability trends affecting the industry?
Yes. Companies investing in bio-based and environmentally sustainable production methods gain competitive advantage as regulations tighten and consumer preferences shift toward eco-friendly products.

Q5: What are the main competitive advantages for market leaders?
Leading firms leverage economies of scale, R&D capabilities, diversified product portfolios, and compliance with strict safety standards to maintain market share and profitability.


End of Report

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.