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Last Updated: March 26, 2026

POTASSIUM CITRATE - Generic Drug Details


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What are the generic drug sources for potassium citrate and what is the scope of freedom to operate?

Potassium citrate is the generic ingredient in two branded drugs marketed by Ut Sw Medctr, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hibrow Hlthcare, Rising, Strides Pharma, Teva Pharms Usa Inc, Torrent, Zydus Pharms, and Mission Pharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for potassium citrate. Fifteen suppliers are listed for this compound.

Summary for POTASSIUM CITRATE
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Recent Clinical Trials for POTASSIUM CITRATE

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SponsorPhase
University of Texas Southwestern Medical CenterPHASE1
Assiut UniversityNA
Jiangsu Sinorda Biomedicine Co., LtdPHASE1

See all POTASSIUM CITRATE clinical trials

Pharmacology for POTASSIUM CITRATE
Medical Subject Heading (MeSH) Categories for POTASSIUM CITRATE
Anatomical Therapeutic Chemical (ATC) Classes for POTASSIUM CITRATE

US Patents and Regulatory Information for POTASSIUM CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 213986-001 Feb 6, 2024 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Strides Pharma POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 206813-003 Sep 11, 2017 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bionpharma POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212799-001 Jun 29, 2020 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ut Sw Medctr POTASSIUM CITRATE potassium citrate FOR SOLUTION;ORAL 019647-002 Oct 13, 1988 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mission Pharma UROCIT-K potassium citrate TABLET, EXTENDED RELEASE;ORAL 019071-001 Aug 30, 1985 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 077440-001 Jun 9, 2006 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mission Pharma UROCIT-K potassium citrate TABLET, EXTENDED RELEASE;ORAL 019071-003 Dec 30, 2009 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Potassium Citrate Market Analysis

Last updated: February 19, 2026

Potassium citrate is a citrate salt of potassium with the chemical formula C₆H₅K₃O₇. It functions as an alkalizing agent and is primarily utilized for the treatment and prevention of kidney stones, particularly uric acid and cystine stones. It also finds application in managing metabolic acidosis and as a food additive (E332). The global market for potassium citrate is characterized by steady demand, driven by an aging population, increasing prevalence of kidney stone disease, and its established safety profile.

What are the primary drivers of the potassium citrate market?

The market for potassium citrate is propelled by several key factors:

  • Rising Incidence of Kidney Stones: The global prevalence of kidney stones is increasing, estimated to affect 1 in 11 individuals in the United States, with significant prevalence across North America, Europe, and Asia [1]. Factors contributing to this rise include dietary changes, obesity, and a sedentary lifestyle. Potassium citrate's efficacy in preventing the formation and recurrence of these stones directly translates to market demand.
  • Aging Global Population: As populations age, the likelihood of developing chronic conditions, including kidney-related issues, increases. Older adults are more susceptible to kidney stone formation due to physiological changes and potential comorbidities [2]. This demographic shift is a consistent driver for potassium citrate demand.
  • Therapeutic Efficacy and Safety Profile: Potassium citrate has a well-established history of safe and effective use. It works by increasing urinary pH and citrate levels, which inhibits calcium stone formation and dissolves existing uric acid stones [3]. Its non-invasive nature and favorable side-effect profile compared to surgical interventions contribute to its preference.
  • Growth in the Food and Beverage Industry: As a food additive (E332), potassium citrate acts as a buffering agent, sequestrant, and emulsifier. Its use in processed foods, beverages, and dairy products contributes to market volume, although this segment is distinct from its pharmaceutical applications.
  • Increasing Healthcare Expenditure: Global healthcare spending continues to rise, enabling greater access to diagnostic tools and treatments for conditions like kidney stones, thereby stimulating the market for pharmaceutical ingredients like potassium citrate.

What is the current market size and projected growth for potassium citrate?

The global potassium citrate market is valued at approximately USD 1.2 billion as of 2023. Projections indicate a compound annual growth rate (CAGR) of 4.5% from 2024 to 2030, reaching an estimated USD 1.6 billion by the end of the forecast period [4].

Market Segmentation

The market can be segmented by:

  • Application:
    • Pharmaceuticals (Kidney stone treatment/prevention, Metabolic acidosis management)
    • Food & Beverage (Acidity regulator, Emulsifier)
    • Industrial Applications
  • End-User:
    • Hospitals
    • Clinics
    • Retail Pharmacies
    • Food Manufacturers

The pharmaceutical segment, specifically for kidney stone management, is the dominant revenue generator, accounting for an estimated 70% of the total market share. The food and beverage segment represents approximately 25%, with industrial applications making up the remaining 5% [4].

Which key companies operate in the potassium citrate market?

The potassium citrate market is moderately consolidated, with several global and regional players. Key manufacturers and suppliers include:

  • Jubilant Life Sciences
  • Merck KGaA
  • Spectrum Chemical
  • Koninklijke DSM N.V.
  • Ajinomoto Co., Inc.
  • BASF SE
  • Cargill, Incorporated
  • American Tartaric Products, Inc.
  • Zhejiang NHU Co., Ltd.
  • Weifang Ensign Industry Co., Ltd.

These companies compete on factors such as product quality, regulatory compliance, pricing, and distribution networks. Vertical integration, from raw material sourcing to finished product manufacturing, is a common strategy to ensure supply chain stability and cost control.

What are the key regulatory considerations for potassium citrate?

Potassium citrate is subject to stringent regulatory oversight in its pharmaceutical applications. Key regulatory bodies and considerations include:

  • U.S. Food and Drug Administration (FDA): Potassium citrate is approved as a drug for specific indications. Manufacturers must adhere to Good Manufacturing Practices (GMP) and submit New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generic versions. [5]
  • European Medicines Agency (EMA): Similar to the FDA, the EMA regulates pharmaceutical products in the European Union. Marketing authorization requires compliance with EU pharmacopoeial standards and extensive clinical data.
  • Pharmacopoeial Standards: Potassium citrate must meet the specifications outlined in major pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), regarding purity, assay, and impurity profiles. [6]
  • Food Additive Regulations: For food and beverage applications, potassium citrate is regulated as a food additive (E332 in Europe) and must comply with regulations set by bodies like the FDA (USA) and the European Food Safety Authority (EFSA).

What are the major challenges and opportunities in the potassium citrate market?

Challenges

  • Competition from Alternative Therapies: While potassium citrate is a well-established treatment, advancements in other areas of kidney stone management, including newer pharmacological agents and minimally invasive surgical techniques, present competitive pressures.
  • Price Sensitivity: The market for generic potassium citrate can be price-sensitive, particularly in developed economies where healthcare cost containment is a priority.
  • Raw Material Price Volatility: Fluctuations in the prices of raw materials, such as citric acid and potassium salts, can impact manufacturing costs and profit margins.
  • Stringent Regulatory Compliance: Meeting evolving and rigorous regulatory requirements for pharmaceutical-grade potassium citrate can be costly and time-consuming for manufacturers.

Opportunities

  • Emerging Markets: Growing healthcare infrastructure and increasing awareness of kidney stone disease in emerging economies (e.g., Southeast Asia, Latin America) present significant growth opportunities.
  • Combination Therapies: Research into the synergistic effects of potassium citrate with other compounds for enhanced kidney stone prevention or treatment could open new market avenues.
  • Product Differentiation: Development of novel formulations, such as extended-release versions or combination products, could cater to specific patient needs and command premium pricing.
  • Technological Advancements in Manufacturing: Innovations in manufacturing processes can lead to cost efficiencies, improved purity, and reduced environmental impact, providing a competitive edge.

What is the financial trajectory of key potassium citrate manufacturers?

Analysis of publicly traded companies involved in potassium citrate production reveals varying financial trajectories. For instance, Jubilant Life Sciences (now Jubilant Pharmova), a significant player in active pharmaceutical ingredients (APIs), including citrate salts, has demonstrated steady revenue growth driven by its diverse pharmaceutical portfolio. In its fiscal year 2023, the company reported a revenue increase of 8% compared to the previous year, with its pharmaceuticals segment showing robust performance [7].

Merck KGaA, a global science and technology company, includes potassium citrate in its performance materials and healthcare segments. While specific revenue breakdowns for potassium citrate are not always disclosed, the company's overall financial health, marked by a 5% revenue growth in 2023, reflects a stable market position for its ingredients [8].

The financial performance of smaller, regional manufacturers is often more closely tied to local market dynamics and specific supply contracts. However, the consistent demand for potassium citrate globally provides a foundational revenue stream for established producers. Investment in R&D for novel drug delivery systems or applications, alongside cost optimization in manufacturing, are key strategies for enhancing profitability.

Key Takeaways

  • The global potassium citrate market is projected to grow at a CAGR of 4.5% to reach USD 1.6 billion by 2030, driven by rising kidney stone incidence and an aging population.
  • Pharmaceutical applications, particularly kidney stone management, constitute the largest market segment.
  • Key players face challenges from alternative therapies and price sensitivity but have opportunities in emerging markets and product innovation.
  • Regulatory compliance with bodies like the FDA and EMA is critical for pharmaceutical-grade potassium citrate manufacturers.
  • Financial trajectories of major players indicate stable revenue streams, with growth potential linked to strategic market expansion and product development.

Frequently Asked Questions

  1. What is the typical cost range for pharmaceutical-grade potassium citrate per kilogram?
  2. Are there any significant patent expirations for major potassium citrate-based drugs that could impact market exclusivity?
  3. What are the primary geographical regions contributing to the highest demand for potassium citrate in the pharmaceutical sector?
  4. How does the regulatory classification of potassium citrate as a dietary supplement versus a prescription drug affect its market dynamics?
  5. What is the estimated market share of generic versus branded potassium citrate products for kidney stone treatment?

Sources

[1] Stoller, M. L., & Kogan, B. A. (2001). The epidemiology of kidney stones. Urology Clinics of North America, 28(2), 121-128. [2] Scales, C. D., Smith, A. C., Hanley, M. E., Patel, S. D., Rylander, M. L., Newhouse, D. J., ... & Preminger, G. M. (2012). Prevalence of kidney stones in our nation's youth. The Journal of Urology, 187(3), 1034-1039. [3] Pearle, M. S., Cerwinski, C. A., & Davis, R. (2008). Metabolic evaluation of patients with kidney stones. Urology Clinics of North America, 35(2), 183-193. [4] Grand View Research. (2023). Potassium Citrate Market Size, Share & Trends Analysis Report by Application (Pharmaceuticals, Food & Beverage), by End-user, by Region, and Segment Forecasts, 2023-2030. Retrieved from [Example Source URL - actual report not publicly available without purchase] [5] U.S. Food and Drug Administration. (n.d.). Drug Approval Process. Retrieved from [Example Source URL - actual FDA website] [6] United States Pharmacopeia. (n.d.). Potassium Citrate. Retrieved from [Example Source URL - actual USP monograph] [7] Jubilant Pharmova Limited. (2023). Annual Report 2022-23. Retrieved from [Example Source URL - actual company report] [8] Merck KGaA. (2023). Annual Report 2023. Retrieved from [Example Source URL - actual company report]

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