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Last Updated: December 31, 2025

FREAMINE 8.5% Drug Patent Profile


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When do Freamine 8.5% patents expire, and what generic alternatives are available?

Freamine 8.5% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in FREAMINE 8.5% 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 Freamine 8.5%

A generic version of FREAMINE 8.5% was approved as amino acids by B BRAUN on April 13th, 2012.

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Summary for FREAMINE 8.5%
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:FREAMINE 8.5% at DailyMed
Drug patent expirations by year for FREAMINE 8.5%

US Patents and Regulatory Information for FREAMINE 8.5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun FREAMINE 8.5% amino acids INJECTABLE;INJECTION 016822-001 Approved Prior to Jan 1, 1982 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 FREAMINE 8.5%

Last updated: August 27, 2025


Introduction

FREAMINE 8.5%, a specialized amino acid infusion therapy, plays a vital role in nutritional support within clinical settings, particularly for patients with compromised gastrointestinal function or metabolic disorders. Its market evolution hinges on complex variables including clinical demand, technological advances, healthcare policies, and competitive landscape. Understanding the intricate dynamics driving FREAMINE 8.5%’s market and projecting its financial trajectory are crucial for stakeholders, ranging from pharmaceutical firms to healthcare providers.


Product Overview and Market Position

FREAMINE 8.5% is an amino acid formulation primarily used for parenteral nutrition. Its formulation offers a balanced amino acid profile for patients unable to ingest nutrients orally or enterally. As an essential component of clinical nutritional therapy, it addresses critical care needs such as malnutrition, hepatic failure, or surgical recovery.

Compared to alternative amino acid solutions, FREAMINE 8.5% distinguishes itself through its established efficacy, safety profile, and compatibility with existing hospital infusion systems. Its positioning within the parenteral nutrition segment offers stability amid fluctuating healthcare demand, especially in intensive care units (ICUs).


Market Dynamics

1. Clinical Demands Driven by Healthcare Trends

The global shift toward enhanced recovery protocols and the increasing prevalence of chronic diseases contribute substantially to the demand for specialized nutritional formulations like FREAMINE 8.5%. The rising incidence of conditions such as cancer, liver diseases, and gastrointestinal disorders underscores the necessity for tailored parenteral nutrition solutions (e.g., [2]).

Furthermore, the aging population worldwide intensifies demand, as elderly patients frequently experience malnutrition or require postoperative nutritional support. The growth in ICU bed capacity, especially in emerging markets, expands the clinical setting for FREAMINE 8.5%.

2. Healthcare Infrastructure and Adoption Barriers

Hospitals and clinics are increasingly adopting parenteral nutrition products, but barriers such as cost constraints, regulatory approval processes, and clinician familiarity influence market penetration. Countries with robust healthcare infrastructure and supportive reimbursement policies are more receptive, thereby positively impacting sales of FREAMINE 8.5%.

3. Competitive Landscape and Technological Innovations

The market features several competitors offering amino acid solutions, primarily from major pharmaceutical companies. Product innovation — including customization, stability improvements, and enhanced safety profiles — influences competitive advantage.

Emerging biotechnological advances in amino acid synthesis and infusion stability are expected to shape future product offerings, prompting manufacturers to innovate for market relevance.

4. Regulatory Environment and Reimbursement Policies

Stringent regulatory frameworks governing parenteral nutrition products influence market access, especially in regions such as the US and EU. Favorable reimbursement schemes and formulary inclusion catalyze adoption, whereas regulatory delays or hurdles may hinder growth. Notably, approval by agencies like the FDA and EMA remains pivotal.


Financial Trajectory Analysis

1. Market Size Estimates and Growth Projections

Current estimates place the global parenteral nutrition market (including FREAMINE 8.5%) at approximately USD 3.5 billion in 2023, with a compound annual growth rate (CAGR) projected around 5-7% until 2030 ([3]). FREAMINE 8.5% contributes a sizable segment within this due to its clinical reliability.

Given the demographic trends and expanding indication spectrum, FREAMINE’s market share is expected to increase modestly. Its financial contribution will likely grow in tandem with the volumetric expansion of parenteral nutrition needs—particularly in developed and high-growth emerging markets.

2. Revenue Drivers and Risk Factors

Key revenue drivers include increased clinical adoption, expanding indications, and healthcare infrastructure investments in developing nations. Conversely, risk factors involve pricing pressures from international competitors, regulatory delays, and potential shifts to alternative therapies such as enteral nutrition or novel nutritional techniques.

3. Profitability Outlook

Gross margins for FREAMINE 8.5% are generally high, attributable to the specialized manufacturing process, intellectual property, and longstanding market presence. The sustainability of profitability relies on operational efficiencies, regulatory compliance, and strategic marketing.

Investment in R&D is pivotal to maintain innovation-driven advantages and adapt to evolving clinical guidelines. Cost-containment strategies and strategic partnerships further influence financial stability.

4. Impact of External Factors

Global economic shifts, including inflation, supply chain disruptions, and geopolitical tensions, could impact manufacturing costs and distribution channels. Additionally, external health crises, such as pandemics, intensify demand for nutritional support but may also strain supply chains, influencing revenue stability.


Future Market Outlook

Assuming continued clinical demand growth, regulatory support, and technological innovation, FREAMINE 8.5% is poised for a steady financial trajectory over the next decade. Manufacturers that adapt to regional demand nuances, enhance product efficacy, and optimize cost structures will likely outperform competitors.

Strategic geographic expansion, especially into Asia-Pacific and Latin America, coupled with targeted marketing to critical care facilities, can bolster revenue streams. Additionally, leveraging data to deepen clinical evidence will strengthen market positioning.


Key Takeaways

  • Growing Clinical Need: An aging population and rising chronic diseases underpin sustained demand for parenteral nutrition solutions like FREAMINE 8.5%.

  • Market Expansion Opportunities: Emerging markets present significant upside but require navigating regulatory hurdles and establishing local partnerships.

  • Competitive and Regulatory Environment: Innovation and compliance are essential to maintain a competitive edge and access key markets.

  • Financial Stability and Growth: Brand loyalty, product efficacy, and operational efficiencies underpin profitability, with growth expected to mirror broader parenteral nutrition trends.

  • Risks and Mitigation: Supply chain resilience, pricing strategies, and continuous R&D are critical to mitigating market and regulatory risks.


FAQs

1. What are the primary therapeutic applications of FREAMINE 8.5%?
FREAMINE 8.5% is used predominantly for parenteral nutritional support in critically ill patients, those with gastrointestinal dysfunction, or metabolic disturbances requiring amino acid infusion.

2. How does FREAMINE 8.5% compare to alternative amino acid solutions?
It offers a balanced amino acid profile with proven safety and efficacy, benefiting from longstanding clinical use, though competition involves newer formulations with potential customization options.

3. What regional factors influence FREAMINE 8.5%’s market growth?
Developed markets benefit from established healthcare infrastructure and reimbursement schemes, while emerging markets present growth opportunities, contingent on regulatory approval and healthcare investment.

4. How do technological advances impact FREAMINE 8.5%’s market trajectory?
Innovations in stability, customization, and infusion systems may enhance product appeal, but also require ongoing R&D investments to retain market relevance.

5. What are the key regulatory challenges facing FREAMINE 8.5%?
Regulatory approval processes vary regionally and demand comprehensive clinical data, which can delay product launches or restrict market access in certain jurisdictions.


References

[1] MarketsandMarkets. Parenteral Nutrition Market by Type, Application, and Region. 2022.
[2] World Health Organization. Malnutrition Data and Trends. 2021.
[3] Grand View Research. Parenteral Nutrition Market Size, Share & Trends Analysis. 2023.

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