Amino acids; dextrose - Generic Drug Details

What are the generic drug sources for amino acids; dextrose and what is the scope of freedom to operate?

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 Class

Amino Acid

Anatomical Therapeutic Chemical (ATC) Classes for amino acids; dextrose

B05BA	Solutions for parenteral nutrition
B05B	I.V. SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

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
Abbott	AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	019564-002	Dec 16, 1986		DISCN	No	No
Baxter Hlthcare	CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	020734-005	Sep 29, 1997		RX	No	No
Baxter Hlthcare	TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride	INJECTABLE;INJECTION	020147-008	Oct 23, 1995		DISCN	No	No
Abbott	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate	INJECTABLE;INJECTION	019712-001	Sep 8, 1988		DISCN	No	No
Abbott	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019565-001	Dec 17, 1986		DISCN	No	No
Baxter Hlthcare	TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019520-009	Sep 23, 1988		DISCN	No	No
Baxter Hlthcare	TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019520-002	Sep 23, 1988		DISCN	No	No

Market Dynamics and Financial Trajectory for Amino Acids and Dextrose in the Pharmaceutical Sector

Last updated: February 19, 2026

What are the current market sizes and growth rates for amino acids and dextrose?

Amino acids and dextrose are foundational compounds in pharmaceutical applications, including parenteral nutrition (PN), clinical nutrition, and biopharmaceutical production.

• Amino acids market size in pharmaceuticals was valued at approximately USD 3.5 billion in 2022, with a compound annual growth rate (CAGR) of 6.8% projected through 2030. Leading segments include essential amino acids used in clinical nutrition and specialty amino acids for drug formulation.
• Dextrose market size related to pharmaceuticals reached around USD 2.8 billion in 2022. It is expected to grow at a CAGR of 5.7% through 2030, driven by increasing demand for intravenous solutions and bioprocessing.

Compound	2022 Market Size (USD billion)	2022-2030 CAGR	Major Use Cases
Amino acids	3.5	6.8%	Parenteral nutrition, amino acid-based therapeutics
Dextrose	2.8	5.7%	Intravenous fluids, cell culture media

What are the key drivers influencing demand?

• Growth in clinical nutrition. Rising prevalence of malnutrition, cancer, and surgical procedures increases demand for amino acid and dextrose-based nutrition formulations.
• Biopharmaceutical manufacturing. Amino acids serve as feedstock in peptide and protein synthesis, while dextrose is used in fermentation processes.
• Aging populations. Older demographics experience higher hospitalization rates, increasing use of parenteral nutrition.
• Regulatory approvals. Advances in formulation and manufacturing processes facilitate broader application of amino acids and dextrose in therapies.

How does supply chain impact market dynamics?

• Raw material sourcing. Amino acids derive primarily from fermentation of corn, soy, or microbial synthesis; dextrose generally from corn or wheat starch via enzymatic conversion.
• Manufacturing capacity. Concentration in a few regions—North America, Europe, and Asia—creates supply risks. Capacity expansions are ongoing.

What are the competitive landscape features?

• Major producers include Ajinomoto, CJ CheilJedang, Evonik Industries, and Roquette. These firms control over 70% of global supply.
• Technologies emphasize microbial fermentation for amino acids, and enzymatic conversion for dextrose, with focus on quality, cost, and regulatory compliance.
• Market consolidation continues, with recent acquisitions and joint ventures to expand capacity and product portfolio.

What are the key policies impacting the market?

• Stricter regulations on pharmaceutical excipients drive demand for high-purity grades.
• International standards (e.g., USP, EP, JP) influence quality requirements and market access.
• Traceability policies increase transparency, raising costs in supply chains.

What is the outlook for financial trajectories?

• Revenue growth expected to remain steady, with periodic disruptions from raw material price volatility and regulatory changes.
• Companies investing in bioprocessing and specialty amino acids anticipate higher margins.
• Market entry of biosynthesized amino acids and bio-based dextrose may create competitive pressure, potentially reducing costs and margins over time.

How are price trends evolving?

Compound	2021 Price Range (USD per kg)	2022 Price Range (USD per kg)	Trend
Amino acids (e.g., L-lysine)	6.00 - 8.50	6.50 - 9.00	Slight upward pressure due to raw material costs
Dextrose (food grade)	0.40 - 0.70	0.45 - 0.75	Mild increase, supplier capacity impacts

What are the risks and uncertainties?

• Raw material price fluctuations linked to agriculture and energy markets.
• Regulatory delays or stricter standards affecting product availability.
• Supply chain disruptions, including geopolitical tensions and transportation constraints.

Key Takeaways

• Growth driven by clinical nutrition, bioprocessing, and aging demographics supports steady expansion.
• Market consolidation and technological advances enhance production efficiencies and product quality.
• Raw material costs and regulatory compliance constitute primary cost and operational risks.
• Emerging bio-based production methods could alter competitive dynamics and pricing structures.

FAQs

1. What are dominant regions for amino acids and dextrose production?
North America, Europe, and Asia-Pacific dominate, with China leading in manufacturing capacity.

2. How are recent innovations impacting the market?
Advances in microbial fermentation and enzymatic processes reduce costs and improve purity, expanding applications.

3. What does future demand for specialty amino acids look like?
Demand is expected to grow faster than general amino acids, driven by drug development and personalized medicine.

4. How does regulatory compliance influence market growth?
Higher standards increase costs but also create barriers to entry, favoring established suppliers.

5. What potential market disruptions could impact financial trajectories?
Raw material shortages, policy changes, and technological shifts pose risks to stable growth.

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Sources:
[1] MarketsandMarkets. (2023). Amino acids market report.
[2] Grand View Research. (2023). Dextrose market analysis.