You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic and what is the scope of patent protection?

Amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic is the generic ingredient in three branded drugs marketed by Icu Medical Inc and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC
Recent Clinical Trials for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC

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

SponsorPhase
Nextrast, Inc.PHASE1
National Institutes of Health (NIH)EARLY_PHASE1
University of ChicagoEARLY_PHASE1

See all AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC

US Patents and Regulatory Information for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Icu Medical Inc AMINOSYN II 8.5% W/ELECTROLYTES amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic INJECTABLE;INJECTION 019437-008 Oct 25, 2002 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Icu Medical Inc AMINOSYN II 3.5% M amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate INJECTABLE;INJECTION 019437-007 Apr 3, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Icu Medical Inc AMINOSYN 8.5% W/ELECTROLYTES amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic INJECTABLE;INJECTION 017673-009 Oct 25, 2002 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  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

Market Dynamics and Financial Trajectory for Pharmaceutical Amino Acids and Salts: A Focus on Magnesium Chloride, Potassium Chloride, Sodium Chloride, and Sodium Phosphate Dibasic

Last updated: August 1, 2025


Introduction

The pharmaceutical industry’s reliance on amino acids and mineral salts such as magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic underscores their critical role across therapeutic, nutritional, and diagnostic applications. As global healthcare demands evolve amid technological innovations and regulatory shifts, understanding current market dynamics and financial trajectories becomes vital for stakeholders ranging from manufacturers to investors.


Market Overview

The global market for pharmaceutical amino acids and mineral salts is characterized by expanding therapeutic applications, rising nutritional supplementation, and continuous innovation. The combination of established demand and emerging trends positions this sector as a lucrative segment within the broader pharmaceutical landscape.

Key Segments and Applications

  • Amino Acids: Primarily utilized in parenteral nutrition, drug formulations, and as precursors for bioactive compounds. Methionine, glutamine, and arginine dominate the amino acid product spectrum, with growth driven by clinical nutrition needs and novel drug delivery systems [[1]].

  • Magnesium Chloride: Valued for its essential mineral properties, used to treat magnesium deficiency, manage arrhythmias, and act as a component in osmotic laxatives.

  • Potassium Chloride: Frequently used to correct hypokalemia, electrolyte management during ICU care, and as an additive in intravenous fluids.

  • Sodium Chloride: The most commonly used saline solution for hydration, drug solubilization, and as a stabilizer in pharmaceutical formulations.

  • Sodium Phosphate Dibasic: Employed in bowel preparation solutions, parenteral nutrition, and phosphate supplementation, benefiting from its high bioavailability [[2]].


Market Dynamics

Drivers

  1. Growing Global Healthcare Expenditure

Rising healthcare spending, especially in Asia-Pacific and Latin America, enhances access to advanced therapies combining these amino acids and salts. For example, Asia-Pacific's pharmaceutical expenditure is projected to grow at a CAGR of approximately 7% through 2028, fueling demand [[3]].

  1. Increased Use in Clinical Nutrition

The aging population and the prevalence of critical illnesses heighten the need for nutrition support, elevating amino acids and mineral salts as essential components. The global clinical nutrition market is anticipated to reach USD 23 billion by 2025, expanding demand for these ingredients [[4]].

  1. Technological Innovations

Advances in drug delivery and formulation science, such as liposomal amino acids and sustained-release mineral salts, improve therapeutic outcomes, thus driving market expansion.

  1. Regulatory Approvals and Patent Expirations

Patent expiries for some amino acids and salts open avenues for generic manufacturers, increasing supply while maintaining regulatory compliance encourages competition.

Challenges

  • Regulatory Barriers

Varying regulatory standards across regions (e.g., FDA, EMA, DRA) complicate global market access, requiring significant compliance investments.

  • Supply Chain Disruptions

COVID-19's impact on raw material availability, especially for amino acids synthesized via complex fermentation processes, increases costs and delays.

  • Price Fluctuations

Raw material price volatility, driven by agricultural inputs (for amino acids) and energy costs (for salt production), impacts profit margins.


Financial Trajectory

Revenue Trends

The combined market value of amino acids and mineral salts in pharmaceuticals exceeds USD 4 billion, with a projected CAGR of 6% between 2023 and 2030. Growth is driven predominantly by expanding applications in injectable and oral nutritional products.

Segment-Specific Outlook

  • Amino Acids: Expected to lead growth with a CAGR of ~7%, driven by increasing utilization in parenteral nutrition and emerging applications like sports medicine and cosmeceuticals.

  • Magnesium and Potassium Chloride: Anticipate steady growth (~5-6%) as electrolyte management maintains clinical indispensability.

  • Sodium Chloride: Mature but resilient, with incremental growth due to its ubiquity and essentiality.

  • Sodium Phosphate Dibasic: Moderate growth (~4-5%) aligning with its niche uses in bowel prep and phosphate deficiency treatments.

Profitability and Market Share

Leading players such as Ajinomoto, ingrained in amino acid production, and Baxter International dominate markets through diversified portfolios, robust supply chains, and strategic regional presence. The increasing entry of generic producers has exerted downward pressure on prices, necessitating efficiency in manufacturing and economies of scale.


Emerging Trends and Future Outlook

  1. Biotechnological Production

Recombinant and synthetic biology approaches are streamlining amino acid synthesis, reducing costs, and enhancing purity, supporting market growth.

  1. Customization and Precision Administration

Personalized nutrition and targeted therapeutics usher in demand for tailored amino acid mixes and mineral formulations, expanding market scope.

  1. Sustainable and Green Chemistry

Environmental concerns drive innovations in sustainable raw material sourcing and manufacturing processes, aligning profitability with eco-friendly practices.

  1. Regulatory Harmonization

International efforts toward standardization could simplify global market entry, reducing barriers and fostering competitive dynamics.


Conclusion

The pharmaceutical market for amino acids and mineral salts remains resilient, with a positive financial trajectory bolstered by expanding healthcare needs, technological advances, and strategic innovations. While challenges like regulatory complexity and raw material volatility persist, industry players investing in innovation and supply chain resilience will capitalize on long-term growth opportunities.


Key Takeaways

  • The market is growing at a compound annual rate of approximately 6-7%, driven by clinical nutrition, technological advances, and expanding healthcare infrastructure globally.
  • Amino acids command the highest growth potential due to their diverse applications, including emerging areas like personalized medicine.
  • Mineral salts such as magnesium, potassium, and sodium salts maintain steady demand, integral to electrolyte management and formulation stability.
  • Supply chain robustness and regulatory compliance are critical for sustaining profitability amid price pressures.
  • Synthetic biology and green manufacturing are pivotal trends shaping future innovation and sustainability.

FAQs

**1. What are the primary

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

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.