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Last Updated: December 22, 2024

AMINOSYN 10% (PH6) Drug Patent Profile


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Which patents cover Aminosyn 10% (ph6), and when can generic versions of Aminosyn 10% (ph6) launch?

Aminosyn 10% (ph6) is a drug marketed by Icu Medical Inc and is included in one NDA.

The generic ingredient in AMINOSYN 10% (PH6) is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aminosyn 10% (ph6)

A generic version of AMINOSYN 10% (PH6) was approved as amino acids by B BRAUN on April 13th, 2012.

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Summary for AMINOSYN 10% (PH6)
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:AMINOSYN 10% (PH6) at DailyMed
Drug patent expirations by year for AMINOSYN 10% (PH6)

US Patents and Regulatory Information for AMINOSYN 10% (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 10% (PH6) amino acids INJECTABLE;INJECTION 017673-008 Nov 18, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

AMINOSYN 10% (PH6) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aminosyn 10% (pH 6)

Introduction to Aminosyn 10% (pH 6)

Aminosyn 10% (pH 6) is a sterile, nonpyrogenic solution for intravenous infusion, designed to provide amino acids for nutritional support. It is used to promote protein synthesis, wound healing, and to reduce the rate of endogenous protein catabolism[1][2].

Clinical Indications and Usage

Aminosyn 10% (pH 6) is indicated for patients who cannot tolerate oral nutrition, either due to inadequate stores of body fat or other clinical conditions. It is administered through peripheral or central venous infusion, often in combination with dextrose, electrolytes, vitamins, and fat emulsions to constitute total parenteral nutrition (TPN)[1][2].

Market Segment and Demand

The demand for Aminosyn 10% (pH 6) is part of the broader market for amino acid solutions, which is driven by several factors:

  • Increasing Need for Nutritional Support: The growing number of patients requiring nutritional support due to conditions such as extensive burns, acute renal failure, and impaired gastrointestinal absorption contributes to the demand for Aminosyn 10% (pH 6)[1][2].
  • Health Awareness and Dietary Trends: The rising consumer awareness of the health benefits associated with amino acids also influences the market. This trend is reflected in the broader food amino acids market, which is expected to grow significantly by 2032[3].

Market Size and Growth

While specific financial data for Aminosyn 10% (pH 6) is not readily available, the overall market for amino acid solutions is substantial and growing. The food amino acids market, for example, was valued at USD 8.17 billion in 2023 and is projected to reach USD 17.87 billion by 2032, growing at a CAGR of 9.1%[3].

Competitive Landscape

The market for amino acid solutions is highly competitive, with several established players providing high-quality products. New entrants face significant obstacles due to the intense competition and the need to meet stringent regulatory and quality standards[3].

Geographical Distribution

The demand for amino acid solutions, including Aminosyn 10% (pH 6), varies geographically. The Asia Pacific region, driven by economic development and increasing health awareness, dominates the global market. Countries like India, Vietnam, and South Korea are key contributors to this growth[3].

Regulatory and Clinical Considerations

Aminosyn 10% (pH 6) must comply with strict regulatory requirements, including those related to its use in different patient populations. For instance, it is contraindicated in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization. Careful dose selection is necessary, especially in elderly patients with decreased renal function[1][2].

Financial Trajectory

The financial trajectory of Aminosyn 10% (pH 6) is likely influenced by several factors:

  • Sales Volume: The increasing demand for nutritional support solutions and the growing awareness of amino acid benefits are expected to drive sales volume.
  • Pricing Strategies: The competitive nature of the market may influence pricing strategies, with manufacturers needing to balance profitability with competitive pricing.
  • Research and Development: Continuous investment in research and development to improve the formulation and delivery of amino acid solutions can also impact the financial performance of the product.

Challenges and Opportunities

Challenges

  • Regulatory Compliance: Adhering to stringent regulatory requirements can be a significant challenge.
  • Competition: The highly competitive market poses a challenge for maintaining market share.
  • Clinical Complexity: The need for careful dose selection and monitoring, especially in vulnerable patient populations, adds complexity to the product's use[1][2].

Opportunities

  • Growing Demand: The increasing need for nutritional support solutions presents a significant opportunity for growth.
  • Expanding Market: The broader food amino acids market's growth trend indicates potential for expansion into new segments.
  • Innovation: Opportunities exist for innovation in formulation and delivery methods, which could enhance the product's efficacy and market appeal[3].

Key Takeaways

  • Aminosyn 10% (pH 6) is a critical component of nutritional support, particularly for patients unable to tolerate oral nutrition.
  • The market for amino acid solutions is growing, driven by health awareness and increasing demand for nutritional support.
  • The product faces a competitive market landscape and must comply with strict regulatory standards.
  • Opportunities for growth exist in expanding market segments and through innovation in product formulation and delivery.

FAQs

Q: What is Aminosyn 10% (pH 6) used for?

A: Aminosyn 10% (pH 6) is used to provide amino acids for nutritional support, promoting protein synthesis and wound healing, and reducing endogenous protein catabolism.

Q: How is Aminosyn 10% (pH 6) administered?

A: It can be administered through peripheral or central venous infusion, often in combination with dextrose, electrolytes, vitamins, and fat emulsions.

Q: What are the contraindications for Aminosyn 10% (pH 6)?

A: It should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.

Q: What is the expected market growth for amino acid solutions?

A: The food amino acids market is projected to grow at a CAGR of 9.1% from 2023 to 2032.

Q: What are the key challenges for Aminosyn 10% (pH 6) in the market?

A: Regulatory compliance, competition, and clinical complexity are significant challenges.

Cited Sources:

  1. Drugs.com - Aminosyn 10%: Package Insert / Prescribing Information
  2. Pfizer - Aminosyn® 10% (pH 6) - Sulfite-Free AN AMINO ACID INJECTION
  3. Polaris Market Research - Food Amino Acids Market Size & Share, Analysis Report by 2032
  4. DailyMed - Aminosyn® -PF 10%Sulfite-Free - DailyMed

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