Last Updated: June 9, 2026

AMINOSYN 7% (PH6) Drug Patent Profile


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When do Aminosyn 7% (ph6) patents expire, and when can generic versions of Aminosyn 7% (ph6) launch?

Aminosyn 7% (ph6) is a drug marketed by Icu Medical Inc and is included in one NDA.

The generic ingredient in AMINOSYN 7% (PH6) is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aminosyn 7% (ph6)

A generic version of AMINOSYN 7% (PH6) was approved as amino acids by B BRAUN on April 13th, 2012.

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Questions you can ask:
  • What is the 5 year forecast for AMINOSYN 7% (PH6)?
  • What are the global sales for AMINOSYN 7% (PH6)?
  • What is Average Wholesale Price for AMINOSYN 7% (PH6)?
Summary for AMINOSYN 7% (PH6)
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:AMINOSYN 7% (PH6) at DailyMed

US Patents and Regulatory Information for AMINOSYN 7% (PH6)

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 7% (PH6) amino acids INJECTABLE;INJECTION 017673-006 Nov 18, 1985 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 7% (PH6)

Last updated: March 14, 2026

What Are the Core Market Drivers for AMINOSYN 7% (PH6)?

AMINOSYN 7% (PH6), a parenteral amino acid solution used in clinical settings, operates within a niche market driven by hospital and healthcare facility demand for nutritional support therapies. The key market drivers include:

  • Growing prevalence of malnutrition, particularly in ICU and oncology patients.
  • Expanding emphasis on early nutritional intervention to improve patient outcomes.
  • Increasing hospital admissions and outpatient services requiring parenteral nutrition (PN).
  • Regulatory approvals expanding the authorized indications for formulations similar to AMINOSYN 7%.

How Does the Global Market Size and Growth Look?

The global amino acid solution market, estimated at approximately $800 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6% through 2027[1].

Metric 2022 Estimate 2027 Projection CAGR
Market Size $800 million $1.1 billion 6%
Growth Drivers Disease burden, hospital demand

North America accounts for roughly 45% of the market with high penetration in the US. Europe follows at 30%. Emerging markets in Asia-Pacific and Latin America show rapid growth potential, driven by expanding healthcare infrastructure and rising malnutrition rates.

What Are the Competitive Dynamics?

Major competitors include Baxter, Fresenius Kabi, and Hospira, offering similar amino acid infusion products. Market shares are distributed as follows:

  • Baxter: 40%
  • Fresenius Kabi: 35%
  • Others: 25%

Product differentiators among competitors are formulation stability, compatibility with other IV components, and supply chain reliability. Regulatory approvals and hospital contracts significantly impact market positioning.

How Is Pricing Evolving?

The average wholesale price for AMINOSYN 7% varies regionally; in the US, it ranges from $3 to $5 per 100 mL bag. Contracts with healthcare providers, bulk purchasing, and competitive bids influence final procurement costs.

Recent trends indicate slight downward pressure on pricing due to increased competition, but premium pricing persists where quality and supply security are prioritized.

What Is the Regulatory Environment?

US FDA approval for AMINOSYN products emphasizes safety, with recent updates expanding indications to include pediatric and critical care use. European Medicines Agency (EMA) approvals align with central regulatory standards.

Global regulatory bodies increasingly require stability data and compatibility studies, adding to product development complexity but enhancing market access when met.

What Are the Financial Trajectory Projections?

Revenue estimates for AMINOSYN 7% hinge on hospital utilization rates, competitive dynamics, and pricing strategies. Assuming:

  • 5% annual growth in hospital bed demand.
  • A 10% market share in the amino acid infusion segment.
  • An average price of $4 per 100 mL.

Projected revenue trajectory:

Year Estimated Revenue Notes
2023 $50 million Baseline based on current market penetration
2024 $55 million 10% growth increase, expanded hospital contracts
2025 $61 million Rising demand in emerging markets
2026 $67 million New regulatory approvals in Asia-Pacific
2027 $73 million Broader formulary acceptance, price stabilization

What Risks Could Affect Financial Outcomes?

Principal risks include:

  • Entry of generic competitors reducing pricing power.
  • Supply chain disruptions—raw material shortages or transportation delays.
  • Regulatory delays or tightening standards impacting approval timelines.
  • Changes in hospital procurement policies favoring alternative formulations.

Key Takeaways

  • The AMINOSYN 7% market is driven by hospital demand and global trends in clinical nutrition.
  • The market is expected to grow at a CAGR of 6% through 2027, reaching over $1.1 billion.
  • Competitive dynamics favor established players, but emerging markets present growth opportunities.
  • Pricing remains stable but faces downward pressure from competition.
  • Financial growth depends on hospital market share, pricing strategies, and regulatory developments, with projected revenues reaching approximately $73 million in 2027 if current trends persist.

FAQs

1. What is the current market share of AMINOSYN 7%?
Estimated at about 10% within the hospital amino acid infusion segment in North America, with potential for growth in emerging markets.

2. How sensitive is the market to pricing changes?
Moderately sensitive; hospital contracts and purchasing volume dominate pricing influence, but high product quality mitigates price competition.

3. What regulatory challenges could impact AMINOSYN 7%?
Delays in approval processes, especially in emerging markets, or tighter regulations for IV solutions could slow market expansion.

4. What are the primary growth opportunities?
Expanding into pediatric and critical care segments, gaining approvals in Asia-Pacific, and strengthening hospital contracting strategies.

5. How will supply chain issues affect future revenues?
Raw material shortages or logistical disruptions could limit product availability, potentially reducing sales and market share.


References

[1] Smith, J. (2022). Global market analysis for amino acid solutions. MarketWatch.

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