You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

AMINO ACIDS; DEXTROSE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for amino acids; dextrose and what is the scope of patent protection?

Amino acids; dextrose is the generic ingredient in forty-seven branded drugs marketed by Abbott, Hospira, Baxter Hlthcare, and Hospira Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for AMINO ACIDS; DEXTROSE
US Patents:0
Tradenames:47
Applicants:4
NDAs:15
Finished Product Suppliers / Packagers: 1
DailyMed Link:AMINO ACIDS; DEXTROSE at DailyMed
Pharmacology for AMINO ACIDS; DEXTROSE
Drug ClassAmino Acid

US Patents and Regulatory Information for AMINO ACIDS; DEXTROSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate INJECTABLE;INJECTION 019682-002 Nov 1, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER amino acids; dextrose INJECTABLE;INJECTION 019681-001 Nov 1, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER amino acids; dextrose INJECTABLE;INJECTION 020734-008 Sep 29, 1997 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abbott AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER amino acids; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride INJECTABLE;INJECTION 019564-004 Dec 16, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020147-005 Oct 23, 1995 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 the Pharmaceutical Drug: Amino Acids; Dextrose

Last updated: July 29, 2025


Introduction

Amino acids and dextrose constitute a foundational component of pharmaceutical and medical nutrition therapy, commonly utilized in intravenous (IV) solutions for rehydration, nutritional support, and specific therapeutic indications. The global market for amino acids and dextrose-based pharmaceutical preparations is experiencing robust growth driven by expanding clinical applications, aging populations, and rising prevalence of malnutrition and chronic diseases. This comprehensive analysis explores the market dynamics shaping this sector and projects its financial trajectory, emphasizing key drivers, challenges, competitive landscape, and future prospects.


Market Overview

The combined amino acids and dextrose pharmaceutical segment is integral to medical nutrition, critical care, and specialty medication formulations. The segment predominantly caters to hospitals, clinics, long-term care facilities, and home healthcare. According to recent industry reports, the global medical nutrition market, which includes amino acids and dextrose solutions, is valued at approximately USD 13 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 6-8% through 2030 [1].

Product Segmentation:

  • Amino Acids: Essential and non-essential amino acids used in parenteral nutrition (PN) formulations.
  • Dextrose: Glucose solutions, often combined with amino acids and electrolytes for comprehensive nutritional support.

Market Drivers

1. Rising Prevalence of Chronic Diseases
Chronic conditions such as cancer, HIV/AIDS, renal failure, and gastrointestinal disorders necessitate parenteral nutritional support. The increasing survival rates of critically ill patients, especially in intensive care units (ICUs), further sustain demand for amino acid and dextrose solutions [2].

2. Growing Geriatric Population
The global aging demographic, particularly in North America and Europe, correlates with heightened malnutrition risk and the need for specialized nutritional support, propelling growth in therapeutic amino acid formulations [3].

3. Advances in Parenteral Nutrition (PN)
Innovations in PN formulations with optimized amino acid profiles and glucose concentrations have improved safety and efficacy, boosting clinician adoption. Regulatory approvals for novel amino acid blends enhance innovation-driven growth.

4. Healthcare Infrastructure Expansion
In emerging markets, expanding healthcare infrastructure and increasing hospital admissions accelerate demand for hospital-based IV therapies, including amino acid and dextrose solutions.

5. Pharmaceutical Mergers and Innovations
Strategic mergers and acquisitions facilitate portfolio diversification and R&D investments, fostering new product development. Notably, biotech firms are exploring amino acids as carriers for targeted therapies and drug delivery systems.


Market Challenges

1. Price Sensitivity and Cost Competition
Most amino acids and dextrose solutions are commoditized, leading to pricing pressures especially in price-sensitive markets like India and Southeast Asia. Cost containment strategies impact profitability for manufacturers.

2. Regulatory Barriers
Stringent regulatory standards across regions can delay product approvals and market entry. Variability in approval processes complicates global supply chains.

3. Supply Chain Disruptions
Dependency on raw material sourcing, predominantly through fermentation and chemical synthesis, makes the sector vulnerable to supply chain disruptions, impacting manufacturing capabilities.

4. Safety Concerns and Adverse Events
Rare but severe adverse events such as infections or metabolic complications associated with IV nutrition formulations influence prescriber preferences and regulatory scrutiny.


Competitive Landscape

The market is characterized by presence of global pharmaceutical giants, such as Baxter International, B. Braun Melsungen, and Fresenius Kabi, alongside regional players specializing in parenteral nutrition formulation. Leading companies focus on:

  • Expanding product portfolios with amino acid blends tailored to specific patient needs.
  • Incorporating glycine, glutamine, or arginine to improve clinical outcomes.
  • Enhancing manufacturing efficiency to reduce costs.
  • Investing in R&D for amino acids with additional therapeutic roles (e.g., neuroprotection, immunomodulation).

Emerging biotech companies are exploring amino acids as drug delivery vectors, further diversifying the competitive landscape.


Financial Trajectory and Future Outlook

Market Growth Projections:
The amino acids and dextrose-based pharmaceutical segment is expected to grow at a CAGR of 6-8% through 2030, reaching an estimated USD 22-25 billion globally. Major markets include North America (approx. 40%), Europe (30%), and Asia Pacific (20%), with the second two regions showing higher growth potential due to healthcare infrastructure development [4].

Regional Dynamics:

  • North America: Strong demand driven by aging population, advanced healthcare, and high R&D investment.
  • Europe: Mature market with steady growth, regulatory frameworks favor innovation.
  • Asia Pacific: Rapid expansion due to increasing healthcare expenditure, rising chronic disease prevalence, and improving hospital infrastructure.

Emerging Trends:

  • Adoption of personalized nutrition formulations.
  • Increased R&D investment in amino acid derivatives as therapeutic agents.
  • Integration of amino acids in combination therapies for complex diseases.
  • Growing demand for plant-based or synthetic amino acids to meet sustainability goals.

Financial Outlook:
Margins are projected to improve as companies optimize supply chains and scale operations. Investments in innovative formulations and regulatory approvals will unlock higher-value market segments, further augmenting revenues.


Regulatory and Policy Impact

Global regulatory agencies like the FDA (US), EMA (Europe), and PMDA (Japan) impose rigorous standards on injectable formulations, affecting market entry timelines. Harmonization efforts, such as ICH guidelines, facilitate cross-border approvals, enabling faster global commercialization.

In emerging markets, government initiatives aimed at improving healthcare access are fostering favorable policies, subsidies, and price controls that influence revenue models.


Conclusion

The pharmaceutical market for amino acids and dextrose solutions is poised for sustained growth, driven by demographic shifts, clinical advancements, and expanding healthcare access. While challenges like pricing pressures and regulatory complexity persist, strategic innovation, supply chain resilience, and regional expansion will underpin long-term value creation. Industry stakeholders must prioritize R&D, regulatory navigation, and cost optimization to capitalize on emerging opportunities.


Key Takeaways

  • Market Expansion: Anticipate multi-billion-dollar growth, with the sector reaching approximately USD 22-25 billion by 2030.
  • Increased Demand Drivers: Aging populations, chronic disease prevalence, and advances in nutritional therapy are key growth engines.
  • Competitive Strategy: Firms should focus on product innovation, tailored formulations, and supply chain efficiencies to remain competitive.
  • Regional Focus: North America and Europe will continue dominant markets, but Asia Pacific offers high-growth prospects driven by economic development.
  • Regulatory Navigation: Harmonized standards and regulatory diligence will be crucial for global market access and product launch success.

FAQs

1. What are the primary therapeutic applications of amino acids and dextrose in pharmaceuticals?
They are mainly used in parenteral nutrition for patients with malnutrition, gastrointestinal dysfunction, or during critical illness, offering essential nutrients and supporting metabolic functions.

2. How do market dynamics differ between developed and emerging economies?
Developed markets benefit from established infrastructure, advanced R&D, and regulatory clarity, whereas emerging economies present growth opportunities driven by expanding healthcare access and evolving clinical practices but face challenges like regulatory variability and price sensitivities.

3. What innovations are shaping the future of amino acid-based pharmaceuticals?
Recent innovations include amino acid derivatives with targeted therapeutic roles, personalized nutritional formulations, and amino acids used as carriers for drug delivery, enhancing therapeutic efficacy.

4. What challenges could impact the growth of this sector?
Price competition, supply chain disruptions, regulatory hurdles, and safety concerns could impede growth unless mitigated through strategic planning and technological advances.

5. How significant is the role of regional policies in influencing market growth?
Regional policies, reimbursement schemes, and healthcare infrastructure investments significantly influence adoption rates, pricing strategies, and market penetration, especially in emerging markets.


References

[1] Mordor Intelligence. (2022). Medical Nutrition Market - Growth, Trends, and Forecasts.
[2] GlobalData. (2021). Parenteral Nutrition Market Analysis.
[3] World Health Organization. (2022). Aging and Health.
[4] MarketsandMarkets. (2022). Amino Acids Market - Global Forecast to 2030.

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.