CITRIC ACID; UREA C-13 - Generic Drug Details

What are the generic sources for citric acid; urea c-13 and what is the scope of patent protection?

Citric acid; urea c-13 is the generic ingredient in one branded drug marketed by Meridian Bioscience and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for CITRIC ACID; UREA C-13

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	76
DailyMed Link:	CITRIC ACID; UREA C-13 at DailyMed

Recent Clinical Trials for CITRIC ACID; UREA C-13

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

Sponsor	Phase
Institute of Hematology & Blood Diseases Hospital, China	PHASE1
University of Melbourne	PHASE2
University of Colorado, Denver	PHASE2

See all CITRIC ACID; UREA C-13 clinical trials

Pharmacology for CITRIC ACID; UREA C-13

Drug Class	Anti-coagulant Calculi Dissolution Agent Helicobacter pylori Diagnostic
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Anatomical Therapeutic Chemical (ATC) Classes for CITRIC ACID; UREA C-13

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

US Patents and Regulatory Information for CITRIC ACID; UREA C-13

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meridian Bioscience	IDKIT:HP	citric acid; urea c-13	FOR SOLUTION, TABLET, FOR SOLUTION;ORAL	021314-001	Dec 17, 2002		RX	Yes	Yes

Market Dynamics and Financial Trajectory for CITRIC ACID; UREA C-13

Last updated: February 20, 2026

What are the current market drivers for CITRIC ACID and UREA C-13?

CITRIC ACID: The global demand for citric acid reached approximately 2.4 million metric tons in 2022, with a compound annual growth rate (CAGR) of 4.2% over the past five years. Key drivers include its application in food and beverages (acidulant and preservative), pharmaceuticals, and personal care products. The expansion of plant-based diets enhances demand in the food sector. The Asia-Pacific region, led by China and India, dominates production and consumption, accounting for about 58% of global consumption.

UREA C-13: Urea labeled with carbon-13 (Urea C-13) is primarily utilized in medical imaging, metabolic studies, and pharmaceutical research. The market size was valued at approximately USD 150 million in 2022, with an expected CAGR of 5.1%. Growth stems from increased investment in diagnostic imaging and personalized medicine. North America and Europe represent the largest markets, with rising adoption of C-13 labeled compounds in clinical research.

How do regulatory policies influence these markets?

CITRIC ACID: Regulatory standards by the U.S. Food and Drug Administration (FDA) and European Food Safety Authority (EFSA) classify citric acid as Generally Recognized As Safe (GRAS). Ongoing regulations on food additive concentrations and safety testing influence manufacturing and import-export policies. The Global Food Safety Initiative (GFSI) standards impact supply chain compliance.

UREA C-13: Its use in research and diagnostics is governed by strict regulations, including Good Manufacturing Practices (GMP) and in some cases, Drug Enforcement Agency (DEA) controls, due to its potential use in controlled substances. The U.S. FDA's Investigational New Drug (IND) applications and European Medicines Agency (EMA) regulations shape commercialization pathways.

What is the competitive landscape and major players?

CITRIC ACID: Major producers include Archer Daniels Midland Company, Cargill, and Jungbunzlauer. The market features significant capacity concentration in China, with local producers supplying approximately 70% of global demand.

UREA C-13: Few suppliers manufacture Urea C-13 due to specialized equipment and regulatory hurdles. Companies such as Cambridge Isotope Laboratories, Sigma-Aldrich (a division of Merck KGaA), and Cambridge Isotope Laboratories dominate the market. Large pharmaceutical and research institutions also produce Urea C-13 in-house.

What are the technological developments impacting these products?

CITRIC ACID: Advances focus on bio-based and fermentation technologies aimed at increasing yield and reducing production costs. Innovations in genetically engineered fungi have improved fermentation efficiency. Investment in sustainable production aligns with clean-label food trends.

UREA C-13: Technologies emphasize efficient isotope labeling, scalable synthesis of labeled compounds, and increased purity standards. Improved synthesis pathways enable higher isotope enrichment levels with lower production costs and fewer byproducts.

How does the pricing trajectory look?

CITRIC ACID: Prices ranged between USD 2,500 and USD 3,000 per metric ton in 2022. Prices are influenced by raw material costs, particularly sugar and molasses, and energy prices. Supply chain disruptions, such as those caused by the COVID-19 pandemic, caused temporary price fluctuations.

UREA C-13: The cost of Urea C-13 ranges from USD 1,500 to USD 3,000 per gram, depending on purity and isotope enrichment levels. Cost drivers include raw material costs, synthesis complexity, and regulatory compliance expenses. Market prices remain relatively stable but are sensitive to advances reducing synthesis costs.

What does the future outlook suggest?

CITRIC ACID: The market is expected to grow steadily, reaching approximately 3.2 million metric tons by 2027. Rising demand for plant-based products and clean-label foods supports growth. Investments in fermentation technology and sustainable production may lower costs further.

UREA C-13: Projected to expand at a CAGR of over 5% through 2027, driven by increased application in personalized medicine, imaging, and metabolomics. Technological improvements in isotope synthesis are expected to decrease costs, broadening access for clinical research.

Key Takeaways

• The citric acid market benefits from its broad application base, notably in food and pharmaceuticals, with growth driven by consumer trends toward natural and plant-based products. Asia-Pacific remains dominant in production and consumption.

• Urea C-13 remains a niche but expanding market, propelled by advancing diagnostic techniques and personalized medicine. North America and Europe lead adoption, with supply limited to specialized producers.

• Regulatory regimes for both products influence manufacturing, sourcing, and commercialization pathways. Environmental and safety standards shape investment and innovation.

• Technological innovations, particularly in fermentation for citric acid and isotope synthesis for Urea C-13, are critical for cost reduction and market expansion.

• Price trends are moderately increasing with raw material costs and supply chain variables; future cost improvements could catalyze broader adoption.

FAQs

1. How does environmental regulation impact citric acid manufacturing?
   Environmental restrictions on emissions and energy use influence production processes, often driving companies toward more sustainable fermentation methods.

2. What are the main barriers to entry for new producers of Urea C-13?
   High capital costs for specialized synthesis equipment, regulatory compliance burdens, and limited scale economies serve as significant barriers.

3. Will supply chain disruptions persist beyond 2023 for citric acid?
   Supply chain resilience improvements are ongoing, but weather effects and geopolitical risks could cause intermittent disruptions into 2024.

4. Are there emerging substitutes for Urea C-13 in clinical research?
   Alternatives like deuterium-labeled compounds exist but currently do not match Urea C-13’s sensitivity and specificity for certain imaging applications.

5. How do raw material prices affect citric acid prices?
   Fluctuations in sugar and molasses prices directly influence production costs, leading to price volatility in the final product.

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References
[1] Markets and Markets. (2022). Citric Acid Market Global Forecast [Report].
[2] Grand View Research. (2022). Urea C-13 Market Size, Share & Trends.
[3] U.S. Food and Drug Administration. (2023). Food Additive Regulations.
[4] European Food Safety Authority. (2022). Review of Food Additive Regulations.
[5] International Federation of Clinical Chemistry and Laboratory Medicine. (2021). Isotope labeled compounds in diagnostics.