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Last Updated: December 22, 2024

AMINOSYN-PF 7% Drug Patent Profile


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Which patents cover Aminosyn-pf 7%, and what generic alternatives are available?

Aminosyn-pf 7% is a drug marketed by Icu Medical Inc and is included in one NDA.

The generic ingredient in AMINOSYN-PF 7% 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-pf 7%

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

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Summary for AMINOSYN-PF 7%
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:AMINOSYN-PF 7% at DailyMed
Drug patent expirations by year for AMINOSYN-PF 7%
Pharmacology for AMINOSYN-PF 7%
Drug ClassAmino Acid

US Patents and Regulatory Information for AMINOSYN-PF 7%

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-PF 7% amino acids INJECTABLE;INJECTION 019398-001 Sep 6, 1985 RX 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-PF 7% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aminosyn-PF 7%

Introduction

Aminosyn-PF 7% is a sulfite-free amino acid injection specifically formulated for the nutritional support of infants and young children, particularly those requiring parenteral nutrition. To understand the market dynamics and financial trajectory of this drug, it is essential to delve into its clinical significance, market demand, competition, and financial aspects.

Clinical Significance and Indications

Aminosyn-PF 7% is indicated for the nutritional support of infants, including those of low birth weight, and young children who require parenteral nutrition due to various reasons such as impaired gastrointestinal absorption or the inability to use the alimentary tract[4][5].

Nutritional Support

The formulation contains a mixture of essential and nonessential amino acids, as well as taurine, which is crucial for bile salt conjugation and central nervous system development. Clinical studies have shown that Aminosyn-PF 7% results in plasma amino acid concentrations similar to those of normal breast or formula-fed infants, promoting weight gains, nitrogen balance, and improving serum protein concentrations[1][4][5].

Market Demand

The demand for Aminosyn-PF 7% is driven by the need for effective parenteral nutrition solutions in pediatric care.

Pediatric Care Needs

Infants and young children with severe gastrointestinal disorders, extensive burns, or those who are unable to feed orally require specialized nutritional support. Aminosyn-PF 7% fills this gap by providing a well-tolerated nitrogen source, making it a critical component in pediatric intensive care units and neonatal wards[4][5].

Growing Healthcare Expenditure

The increasing expenditure on healthcare, particularly in neonatal and pediatric care, is a significant factor driving the demand for specialized nutritional products like Aminosyn-PF 7%. As healthcare systems invest more in advanced treatments and nutritional therapies, the market for such products is expected to grow.

Competitive Landscape

The market for pediatric amino acid solutions is competitive, with several pharmaceutical companies offering similar products.

Key Competitors

Companies like Hospira Healthcare Corporation (now part of Pfizer) and ICU Medical are prominent players in this market. These companies compete based on the formulation, safety profile, and ease of administration of their products[2][5].

Differentiation

Aminosyn-PF 7% differentiates itself through its sulfite-free formulation, which is particularly important for pediatric patients who may be sensitive to sulfites. Additionally, its specific amino acid composition and the inclusion of taurine set it apart from other products in the market[1][4].

Financial Trajectory

The financial performance of Aminosyn-PF 7% can be analyzed through several key metrics.

Revenue Growth

Given the increasing demand for specialized pediatric nutritional solutions, the revenue from Aminosyn-PF 7% is likely to grow. This growth is supported by the expanding healthcare expenditure and the critical need for effective parenteral nutrition in pediatric care.

Market Share

Aminosyn-PF 7% holds a significant market share in the pediatric amino acid solutions segment. Its established brand and clinical efficacy contribute to its market position, although exact market share figures are not publicly disclosed.

Pricing Strategy

The pricing of Aminosyn-PF 7% is influenced by factors such as production costs, regulatory approvals, and market competition. The product is available in various package sizes, including 500 mL and 1000 mL flexible plastic containers, which allows for flexible pricing strategies to cater to different market segments[2][4].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of Aminosyn-PF 7%.

FDA Approvals and Compliance

Aminosyn-PF 7% is approved by the FDA for use in pediatric patients, and it must comply with stringent regulatory standards. Compliance with these regulations ensures the product's safety and efficacy, which in turn affects its market acceptance and financial performance[4][5].

Distribution and Availability

The distribution and availability of Aminosyn-PF 7% are critical for its market success.

Hospital and Pharmacy Sales

The product is primarily sold through hospital and pharmacy channels. Its availability in pharmacy bulk packages and its inclusion in formulary lists of healthcare organizations facilitate its widespread use[2][5].

Financial Projections

While exact financial projections for Aminosyn-PF 7% are not publicly available, several factors suggest a positive financial trajectory.

Increasing Demand

The growing need for pediatric nutritional solutions and the expanding healthcare expenditure are likely to drive increased demand for Aminosyn-PF 7%.

Competitive Advantage

The product's unique formulation and clinical efficacy provide a competitive advantage, which can translate into higher sales and revenue.

Regulatory Stability

Compliance with regulatory standards ensures the product's continued approval and market presence, contributing to stable financial performance.

Key Takeaways

  • Clinical Significance: Aminosyn-PF 7% is crucial for the nutritional support of infants and young children requiring parenteral nutrition.
  • Market Demand: Driven by the need for effective pediatric nutritional solutions and growing healthcare expenditure.
  • Competitive Landscape: Competes with other pediatric amino acid solutions, differentiated by its sulfite-free formulation and specific amino acid composition.
  • Financial Trajectory: Expected to grow due to increasing demand, competitive advantage, and regulatory stability.
  • Regulatory Environment: Compliance with FDA regulations ensures safety, efficacy, and market acceptance.

FAQs

Q: What is Aminosyn-PF 7% used for?

A: Aminosyn-PF 7% is used for the nutritional support of infants and young children requiring parenteral nutrition.

Q: What are the key components of Aminosyn-PF 7%?

A: It contains a mixture of essential and nonessential amino acids, as well as taurine.

Q: Why is taurine important in Aminosyn-PF 7%?

A: Taurine is crucial for bile salt conjugation and central nervous system development in infants.

Q: How is Aminosyn-PF 7% administered?

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

Q: What are the potential side effects of Aminosyn-PF 7%?

A: While generally well-tolerated, it is essential to monitor for any signs of adverse reactions, and the addition of cysteine hydrochloride may contribute to the chloride load.

Sources

  1. Aminosyn PF 7% - 10%.PI - Hospira Healthcare Corporation.
  2. Aminosyn™-PF, Sulfite-Free - ICU Medical.
  3. Incorporating pharmacoequity in the formulary review and ... - Academic.oup.com.
  4. Aminosyn® -PF 7%Sulfite-Free - DailyMed.
  5. Aminosyn® -PF 7% - Sulfite-Free AN AMINO ACID INJECTION - Pfizer.

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