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Last Updated: March 26, 2025

AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER Drug Patent Profile


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When do Aminosyn Ii 5% In Dextrose 25% In Plastic Container patents expire, and what generic alternatives are available?

Aminosyn Ii 5% In Dextrose 25% In Plastic Container is a drug marketed by Abbott, Hospira, and Hospira Inc. and is included in five NDAs.

The generic ingredient in AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER is amino acids; calcium chloride; dextrose; magnesium chloride; 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; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride profile page.

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Summary for AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
US Patents:0
Applicants:3
NDAs:5
DailyMed Link:AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER at DailyMed
Drug patent expirations by year for AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER

US Patents and Regulatory Information for AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbott AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER amino acids; dextrose INJECTABLE;INJECTION 019565-001 Dec 17, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER amino acids; dextrose INJECTABLE;INJECTION 019681-006 Nov 1, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Abbott AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER amino acids; dextrose INJECTABLE;INJECTION 019713-003 Sep 9, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Abbott AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER amino acids; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride INJECTABLE;INJECTION 019714-003 Sep 12, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for AMINOSYN II 5% in 25% Dextrose

Introduction

AMINOSYN II 5% in 25% Dextrose is a critical component in total parenteral nutrition (TPN), providing essential amino acids and calories for patients who cannot receive nutrition through the gastrointestinal tract. This article delves into the market dynamics and financial trajectory of this drug, highlighting its clinical significance, market trends, and financial implications.

Clinical Significance and Indications

AMINOSYN II 5% in 25% Dextrose is indicated for central vein infusion to prevent nitrogen loss and negative nitrogen balance in patients with impaired gastrointestinal absorption or increased metabolic requirements, such as those with extensive burns or acute renal failure[4][5].

Market Demand and Trends

The demand for parenteral nutrition solutions like AMINOSYN II is driven by several factors:

  • Increasing Need for TPN: The growing number of patients requiring intensive care and those with conditions that impair gastrointestinal function contributes to the demand for TPN solutions[4].
  • Advancements in Healthcare: Improvements in healthcare infrastructure and the availability of advanced medical treatments increase the use of parenteral nutrition.
  • Aging Population: An aging population with higher incidence rates of chronic diseases also drives the demand for nutritional support solutions.

Competitive Landscape

The market for parenteral nutrition solutions is competitive, with several key players:

  • Pfizer: As the manufacturer of AMINOSYN II, Pfizer holds a significant market share in the parenteral nutrition segment[2].
  • Other Manufacturers: Companies like Baxter and B. Braun also offer similar products, contributing to a competitive market environment.

Pricing and Reimbursement

The pricing of AMINOSYN II 5% in 25% Dextrose can vary based on several factors, including the volume of the solution, the presence of electrolytes, and the geographic location.

  • Hospital and Clinical Settings: The cost is often covered by healthcare providers and insurance plans, which can influence pricing strategies.
  • Reimbursement Policies: Government and private insurance reimbursement policies play a crucial role in determining the financial viability of these products[3].

Financial Trajectory

Historical Spending

The pharmaceutical market, including parenteral nutrition solutions, has seen steady growth over the past few decades. Net drug spending in the U.S. has increased by 20% over the past 10 years, with an average annual growth rate of 2%[3].

Revenue Growth

AMINOSYN II, as part of the broader parenteral nutrition market, benefits from this overall growth trend. The specific revenue growth for AMINOSYN II is influenced by its market share, pricing strategies, and the increasing demand for TPN solutions.

Cost and Profit Margins

The cost of producing AMINOSYN II includes raw material costs, manufacturing expenses, and regulatory compliance. Profit margins are affected by competition, pricing strategies, and the ability to maintain market share.

Future Outlook

The future financial trajectory of AMINOSYN II is promising due to several factors:

  • Growing Demand: Increasing healthcare needs and advancements in medical treatments are expected to drive continued demand.
  • Innovation: Continuous innovation in formulation and delivery systems can help maintain market competitiveness.
  • Regulatory Environment: Favorable regulatory environments and reimbursement policies can support the financial performance of the product.

Challenges and Complications

Despite the positive outlook, there are several challenges and complications to consider:

  • Metabolic Complications: Patients on AMINOSYN II can experience metabolic complications such as hyperglycemia, hyperosmolar nonketotic states, and electrolyte imbalances, which require careful monitoring and management[5].
  • Allergic Reactions: The presence of sulfites and aluminum in the solution can lead to allergic reactions and toxicity, particularly in patients with impaired kidney function[2].
  • Compliance and Safety: Ensuring compliance with storage and administration guidelines is crucial to maintain the safety and efficacy of the product.

Key Takeaways

  • Clinical Importance: AMINOSYN II 5% in 25% Dextrose is a vital component in total parenteral nutrition, addressing critical nutritional needs in patients.
  • Market Demand: The demand is driven by increasing healthcare needs and advancements in medical treatments.
  • Financial Performance: The product benefits from overall growth in the pharmaceutical market, with a promising future outlook.
  • Challenges: Metabolic complications, allergic reactions, and compliance issues need careful management.

FAQs

What is AMINOSYN II 5% in 25% Dextrose used for?

AMINOSYN II 5% in 25% Dextrose is used for central vein infusion to prevent nitrogen loss and negative nitrogen balance in patients who cannot receive nutrition through the gastrointestinal tract.

What are the potential complications of using AMINOSYN II?

Potential complications include metabolic acidosis, hyperglycemia, hyperosmolar nonketotic states, dehydration, and electrolyte imbalances. Allergic reactions to sulfites and aluminum toxicity are also possible.

How is AMINOSYN II administered?

AMINOSYN II is administered via central vein infusion. The solution is mixed from two chambers containing amino acids and dextrose, respectively, and the infusion rate is adjusted based on the patient's protein and caloric requirements.

What are the key factors driving the demand for AMINOSYN II?

The demand is driven by the increasing need for total parenteral nutrition, advancements in healthcare, and an aging population with higher incidence rates of chronic diseases.

How does the pricing of AMINOSYN II affect its market dynamics?

Pricing is influenced by factors such as volume, presence of electrolytes, and geographic location. Reimbursement policies and competition also play significant roles in determining the financial viability of the product.

Sources

  1. Aminosyns in Dual-Chamb. (5/97)
  2. AMINOSYN® II AN AMINO ACID INJECTION
  3. Drug Expenditure Dynamics 1995-2020 - IQVIA
  4. Aminosyn II 5% in 25% Dextrose (Amino Acid Injection 5 ... - RxList
  5. AMINOSYN® II with ELECTROLYTES - accessdata.fda.gov

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.