Last Updated: May 10, 2026

AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Aminosyn Ii 4.25% M In Dextrose 10% In Plastic Container, and what generic alternatives are available?

Aminosyn Ii 4.25% M In Dextrose 10% In Plastic Container is a drug marketed by Abbott and Hospira Inc and is included in two NDAs.

The generic ingredient in AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER is amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate profile page.

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Summary for AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
US Patents:0
Applicants:2
NDAs:2
DailyMed Link:AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER

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 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate INJECTABLE;INJECTION 019564-003 Dec 16, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  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

Market Dynamics and Financial Trajectory for AMINOSYN II 4.25% with Dextrose 10% in Plastic Container

Last updated: February 10, 2026

Overview AMINOSYN II 4.25% in Dextrose 10% (manufactured or marketed by Fresenius Kabi or other), is a parenteral nutrition (PN) product used primarily in hospitals for patients needing intravenous amino acid and glucose supplementation. The product's market relies on hospital demand, ICU utilization, and broader trends in intravenous (IV) therapy.

Market Overview The global intravenous (IV) nutrition market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.5% to 6.2% from 2022 to 2030, driven by increasing hospitalizations, aging populations, and rising prevalence of malnutrition in clinical settings[1].

Key Market Drivers:

  • Rising Hospitalizations: Increased demand for nutritional support in critically ill patients.
  • Aging Demographics: Older populations with higher nutritional deficiency risks.
  • Chronic Disease Burden: Growth in conditions like cancer, HIV, and gastrointestinal disorders necessitates PN use.
  • Healthcare Infrastructure Growth: Expansion of hospitals and ICU capacity, especially in emerging markets.
  • Regulatory Approvals & Reimbursements: Favorable policies enhance adoption rates[2].

Market Segmentation & Competitive Landscape The dominant players include Fresenius Kabi, Baxter, B. Braun Melsungen, and ICU Medical. These companies produce similar amino acid formulations and compete on pricing, supply chain reliability, and clinical acceptance.

The product specifics—4.25% amino acids combined with 10% dextrose—are considered standard, with variations tailored for specific clinical needs. The brand positioning leans heavily on hospital procurement contracts.

Pricing & Revenue Model Average wholesale price (AWP) for similar products ranges from $3.50 to $6.00 per 100 mL depending on formulations, regional markets, and hospital procurement agreements. The total addressable market is estimated at $1.2 billion globally, with North America commanding approximately 50% of volume due to mature healthcare infrastructure[3].

Financial Trajectory & Growth Forecasts Projection models forecast the following over the next five years:

Year Estimated Market Size (USD billion) Compound Growth Rate Key Factors
2023 $1.25 4.5% Pandemic recovery, hospital capacity expansion
2025 $1.40 4.7% Increased ICU admissions
2027 $1.60 4.8% Aging populations, healthcare digitization

Growth is tempered by pricing pressures, supply chain challenges, and hospital budget constraints post-pandemic. The trend toward outpatient nutrition solutions and biosimilars may introduce competitive pressures.

Regulatory & Supply Chain Considerations Approval pathways remain stable in developed markets. Regulatory bodies such as FDA and EMA require stringent quality controls, impacting production costs but ensuring market access. Supply chain disruptions—particularly in raw materials and container manufacturing—may influence availability and pricing, especially with recent geopolitical tensions and global logistics issues[4].

Key Trends Impacting Trajectory:

  • Adoption of more personalized nutrition formulations.
  • Increasing integration of nutritional products into hospital electronic health records.
  • Regulatory approvals for pediatric, geriatric, and specialized populations.
  • Focus on reducing hospital stays, boosting demand for outpatient IV products.

Conclusion AMINOSYN II 4.25% with Dextrose 10% stands to benefit from a stable, growing IV nutrition market. Growth hinges on hospital demand, regulatory landscape, and supply chain robustness. Price sensitivity and hospital procurement strategies are key factors that will influence revenue potential.


Key Takeaways

  • The global IV nutrition market is forecast to grow at a CAGR of roughly 5% through 2030.
  • North America accounts for half of the market, driven by mature healthcare systems and higher ICU utilization.
  • Market growth is supported by demographic shifts and rising hospitalization rates but faces competitive pressures and supply constraints.
  • Pricing remains a major factor; estimates suggest a stable revenue outlook for well-positioned manufacturers.
  • Supply chain stability and regulatory approval are critical for sustained growth.

FAQs

  1. What is the primary demand driver for AMINOSYN II 4.25%?
    Hospital ICU admissions and chronic disease management increase demand for intravenous nutritional products.

  2. How does pricing impact revenue projections?
    Pricing pressures and hospital procurement negotiations can limit revenue growth, especially in highly competitive regions.

  3. Are there regulatory risks for this product?
    Yes, especially regarding manufacturing quality, sterile processing, and regional approval processes.

  4. What market segments could threaten growth?
    Outpatient nutritional products and biosimilars might reduce hospital-based demand over time.

  5. How sensitive is the market to supply chain disruptions?
    Highly sensitive; interruptions in raw materials or packaging components can limit availability and affect sales.


References

[1] Grand View Research. "Intravenous Nutrition Market Size, Share & Trends Analysis Report." 2022.
[2] IQVIA Institute. "The Future of Nutrition in Healthcare," 2021.
[3] MarketWatch. "Global IV Nutrition Market." 2022.
[4] McKinsey & Company. "Resilient Supply Chains in Healthcare," 2022.

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