AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER Drug Patent Profile

When do Aminosyn Ii 4.25% W/ Elect And Adjusted Phosphate In Dextrose 10% In Plastic Container patents expire, and when can generic versions of Aminosyn Ii 4.25% W/ Elect And Adjusted Phosphate In Dextrose 10% In Plastic Container launch?

Aminosyn Ii 4.25% W/ Elect And Adjusted Phosphate 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% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER is amino acids; dextrose; magnesium chloride; potassium acetate; potassium chloride; potassium phosphate, dibasic; sodium chloride. 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 acetate; potassium chloride; potassium phosphate, dibasic; sodium chloride profile page.

Summary for AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	2
NDAs:	2
DailyMed Link:	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE 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% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium acetate; potassium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	019712-002	Sep 8, 1988		DISCN	No	No
Hospira Inc	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium acetate; potassium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	019682-003	Nov 1, 1988		DISCN	No	No

Market Dynamics and Financial Trajectory for AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

Last updated: July 31, 2025

---

Introduction

The pharmaceutical landscape surrounding amino acid solutions such as AMINOSYN II 4.25% with Electrolytes and Adjusted Phosphate in Dextrose 10% in Plastic Containers offers a nuanced perspective characterized by evolving clinical needs, regulatory standards, and market competition. This intravenous (IV) nutritional product, primarily used in critical care and nutritional support settings, occupies a specialized segment pivotal in hospital and healthcare provider inventories. This analysis explores the market mechanisms influencing its demand and supply, followed by an evaluation of its financial trajectory, grounded in industry trends and regulatory frameworks.

---

Market Overview

1. Product Profile and Therapeutic Use

AMINOSYN II, a balanced amino acid infusion solution with supplemental electrolytes and phosphate, caters to patients requiring parenteral nutrition, especially those with compromised gastrointestinal function. Its formulation in dextrose 10% facilitates calorie delivery, while the plastic container format aids in safer, more convenient hospital handling.

2. Industry Context

The global IV nutrition market, projected to grow annually at approximately 6% through 2025, encompasses products like amino acid solutions, lipid emulsions, and carbohydrate-based infusions. The amino acid segment, including formulations like AMINOSYN II, constitutes a vital component, driven by increasing incidences of malnutrition in hospital settings and an aging patient population with complex nutritional needs.

---

Market Dynamics

1. Clinical and Demographic Drivers

• Rising Prevalence of Critical Illness and Malnutrition: An increase in surgeries, chronic diseases, and intensive care cases elevates demand for total parenteral nutrition (TPN) products. The 2021 Global Malnutrition Report highlights that over 690 million people are malnourished, emphasizing the need for specialized nutritional support.

• Aging Population: Globally, populations over 65 years account for an increasing share of hospital admissions, many of whom require amino acid-based IV nutrition.

• Advancements in Parenteral Nutrition Protocols: Improved formulations tailored for specific patient groups enhance the utilization of amino acid solutions like AMINOSYN II, favoring clinical adoption.

2. Regulatory and Reimbursement Landscape

• Stringent Approval Processes: U.S. FDA and EMA regulations ensure safety and efficacy but can prolong product approval timelines, impacting market entry and growth.

• Reimbursement Policies: Reimbursement frameworks such as Medicare, Medicaid, and insurance coverage influence hospital procurement decisions. Favorable reimbursement tends to boost volume sales, while policy shifts could pose barriers.

3. Manufacturing and Supply Chain Considerations

• Production Costs and Scalability: The complexity of formulating amino acid solutions with electrolytes and phosphate, combined with sterility requirements, influences manufacturing costs and profitability.

• Supply Chain Disruptions: Factors such as raw material shortages, logistical bottlenecks, and global health crises can affect product availability.

4. Competitive Landscape

• Key Industry Players: Companies like Baxter, Hospira (Pfizer), and Fresenius dominate the market, offering proprietary formulations with economies of scale.

• Differentiation Factors: Variants offering optimized electrolyte/phosphate balancing, stability improvements, or delivery formats can command premium pricing.

---

Financial Trajectory

1. Revenue Trends

• Market Penetration and Adoption: Hospitals tend to preferentially order established brands with proven safety profiles, potentially limiting new entrants' market share.

• Pricing Strategies: Premium pricing can be maintained through demonstrating superior clinical outcomes or stability, but pricing pressures from generic manufacturers are intense.

• Volume Growth: Driven by the overall expansion of TPN use, especially in critical care units, volume growth for products like AMINOSYN II is expected to sustain moderate gains.

2. Cost Dynamics

• Manufacturing Expenses: Investments in sterile manufacturing facilities and quality controls influence profit margins.

• Regulatory Compliance: Ongoing compliance costs for monitoring, quality assurance, and updates impact overall expenses.

3. Profitability Outlook

• Margins: Operating margins depend on competitive positioning, manufacturing efficiencies, and pricing strategies. High barriers to entry and patent protections on proprietary formulations could buttress margins temporarily.

• Market Saturation: As the product reaches widespread adoption, growth may plateau unless clinical innovations or new formulations emerge.

4. Impact of External Factors

• Global Healthcare Spending: An increase in healthcare budgets in emerging economies presents growth opportunities albeit tempered by local regulatory hurdles.

• Pandemic Influence: COVID-19 underscored the importance of critical care supplies, likely bolstering demand; however, supply chain vulnerabilities and regulatory delays present risks.

---

Projected Market and Financial Trends

• Short-to-Medium Term (1-3 Years): Steady growth aligned with hospital procurement cycles and critical care demands. Price stability and gradual volume increases are anticipated.

• Long Term (3-5 Years): Potential driven by technological innovations—such as improved formulations with longer shelf-life—and expansion into emerging markets. Regulatory support for tailored amino acid solutions may create favorable conditions.

---

Strategic Implications for Stakeholders

• Manufacturers: Should focus on optimizing supply chain resilience, investing in differentiated formulations, and navigating regulatory pathways efficiently.

• Healthcare Providers: Need to balance cost considerations with clinical outcomes, favoring evidence-backed products.

• Investors: Opportunities exist in companies demonstrating technological innovation, robust manufacturing, and regulatory agility capitalize on market growth.

---

Key Takeaways

• The market for amino acid solutions like AMINOSYN II is driven by growing critical care demands, demographic shifts, and advancements in nutritional protocols.
• Regulatory landscapes and reimbursement policies significantly influence market accessibility and growth potential.
• Financial trajectories are characterized by moderate, stable revenue growth, with margins affected by manufacturing costs and competitive pressures.
• Long-term growth prospects hinge on innovation, global expansion, and supply chain robustness.
• Strategic focus on differentiation and operational efficiencies can bolster profitability and market position.

---

FAQs

1. What are the main factors influencing demand for AMINOSYN II in the hospital setting?
   Clinical need for parenteral nutrition, demographic shifts such as aging populations, and advancements in critical care protocols predominantly drive demand.

2. How do regulatory policies impact the market for amino acid infusions?
   Stringent approval processes and ongoing quality requirements can delay product launches but ensure safety and efficacy, indirectly influencing market competitiveness.

3. What competitive advantages can manufacturers leverage in this market?
   Differentiation through formulation stability, customized electrolyte balance, supply chain reliability, and compliance efficiency are key advantages.

4. What are the major risks affecting AMINOSYN II’s financial outlook?
   Price erosion from generic competition, supply chain disruptions, evolving regulatory standards, and shifts in reimbursement policies pose significant risks.

5. What future market trends should industry players monitor?
   Innovation in amino acid formulations, expansion into emerging markets, technological improvements extending shelf life, and policy developments are critical trends.

---

References

1. World Health Organization. (2021). The Malnutrition Report.
2. MarketWatch. (2022). Intravenous (IV) Nutrition Market Analysis.
3. U.S. Food and Drug Administration. (2022). Parenteral Nutrition Regulations.
4. GlobalData Healthcare. (2022). Critical Care and Nutritional Support Market Outlook.
5. Healthcare Financial Management Association. (2021). Reimbursement Models for Parenteral Nutrition.