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Last Updated: December 22, 2024

PROCALAMINE Drug Patent Profile


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Which patents cover Procalamine, and when can generic versions of Procalamine launch?

Procalamine is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in PROCALAMINE is amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride profile page.

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Summary for PROCALAMINE
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US Patents and Regulatory Information for PROCALAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun PROCALAMINE amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride INJECTABLE;INJECTION 018582-001 May 8, 1982 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

PROCALAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ProcalAmine

Introduction

ProcalAmine, a sterile, nonpyrogenic intravenous injection containing 3% amino acid and 3% glycerin with electrolytes, is a crucial component in parenteral nutrition. Understanding its market dynamics and financial trajectory is essential for stakeholders, including healthcare providers, investors, and pharmaceutical companies.

Market Need and Demand

ProcalAmine is indicated for preserving body protein and improving nitrogen balance in well-nourished, mildly catabolic adult patients requiring short-term parenteral nutrition. The demand for such products is driven by the need for effective nutritional support in clinical settings, particularly for patients recovering from surgery, trauma, or those with certain metabolic disorders[1][2][3].

Competitive Landscape

The parenteral nutrition market is competitive, with several products available, including ProcalAmine, Clinimix, and Perikabiven. ProcalAmine stands out due to its unique composition of amino acids and glycerin, which provides a balanced energy source and maintains electrolyte balance. However, the market is also subject to shortages, particularly of amino acid solutions, which can impact the availability and pricing of these products[4].

Pricing and Cost Considerations

The pricing of ProcalAmine is influenced by several factors, including production costs, regulatory compliance, and market demand. Given its specific formulation and the need for precise dosing, the cost can be significant. For instance, a typical daily dose of approximately three liters of ProcalAmine provides 90 grams of amino acids and 390 nonprotein calories, which can be costly, especially for extended treatment periods[1][2][3].

Financial Performance

The financial performance of ProcalAmine is tied to the overall parenteral nutrition market, which has seen fluctuations due to supply chain issues and regulatory challenges. Despite these challenges, the market for parenteral nutrition solutions remains robust due to the critical need for these products in healthcare settings.

Revenue Streams

Revenue for ProcalAmine is generated primarily through hospital and clinical sales. The product's unique formulation and the necessity of parenteral nutrition in certain patient populations ensure a steady demand, contributing to stable revenue streams.

Impact of Shortages

Shortages in amino acid solutions and other parenteral nutrition components can significantly impact the financial trajectory of ProcalAmine. These shortages, often due to manufacturing issues, supply and demand imbalances, or natural disasters, can lead to increased costs and reduced availability, affecting both the manufacturer's revenue and the overall market dynamics[4].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of ProcalAmine. Compliance with FDA standards and other regulatory requirements is essential for maintaining market approval and avoiding costly recalls or warnings. Any non-compliance can lead to significant financial penalties and reputational damage[4].

Clinical Studies and Efficacy

Clinical studies have demonstrated the safety and efficacy of ProcalAmine in maintaining nitrogen balance and providing necessary energy substrates. For example, a study involving patients recovering from major trauma or surgery showed that ProcalAmine, when combined with lipid emulsions, was well-tolerated and effective in improving nitrogen balance[5].

Geriatric and Pediatric Use

While ProcalAmine is primarily indicated for adult use, its application in geriatric and pediatric populations is subject to careful consideration. For geriatric patients, dose selection must be cautious due to potential renal function impairment. In pediatric patients, the dosage is based on grams of amino acids per kilogram of body weight, and the solution must not exceed twice normal serum osmolarity[1][2][3].

Market Trends

The parenteral nutrition market is evolving with advancements in formulation and delivery systems. Trends include the development of more balanced and personalized nutrition solutions, as well as strategies to mitigate shortages and ensure consistent supply chains.

Conservation Strategies

Given the frequent shortages in parenteral nutrition products, conservation strategies are becoming increasingly important. These strategies include optimizing dosing, using alternative products when available, and implementing efficient supply chain management to minimize the impact of shortages on patient care[4].

Key Takeaways

  • Market Demand: ProcalAmine meets a critical need in parenteral nutrition, particularly for mildly catabolic patients.
  • Competitive Landscape: The market is competitive, with ProcalAmine offering a unique formulation.
  • Pricing and Cost: Pricing is influenced by production costs, regulatory compliance, and market demand.
  • Financial Performance: Revenue is stable but can be impacted by shortages and regulatory issues.
  • Regulatory Environment: Compliance with FDA standards is crucial for maintaining market approval.
  • Clinical Studies: ProcalAmine has been shown to be safe and effective in clinical studies.
  • Geriatric and Pediatric Use: Requires careful dose selection and monitoring.
  • Market Trends: Includes the development of personalized nutrition solutions and conservation strategies.

FAQs

What is ProcalAmine used for?

ProcalAmine is used to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic adult patients requiring short-term parenteral nutrition.

What are the key components of ProcalAmine?

ProcalAmine contains 3% amino acid, 3% glycerin, and maintenance electrolytes.

What are the potential side effects of ProcalAmine?

While clinical trials did not observe significant side effects, high concentrations of glycerol can cause hemolysis, hemoglobinuria, and renal damage if not properly formulated and administered[1].

How is ProcalAmine administered?

ProcalAmine is administered peripherally, with a typical daily dose of approximately three liters providing 90 grams of amino acids and 390 nonprotein calories[1][2][3].

What are the conservation strategies for managing ProcalAmine shortages?

Conservation strategies include optimizing dosing, using alternative products, and efficient supply chain management to minimize the impact of shortages on patient care[4].

Sources

  1. Drugs.com: ProcalAmine: Package Insert / Prescribing Information.
  2. Drugs.com: ProcalAmine Dosage Guide.
  3. RxList: Procalamine (Amino Acid and Glycerin): Side Effects, Uses.
  4. NHIA: Surviving Shortages and Managing Parenteral Nutrition Patients.
  5. PubMed: Safety and efficacy of glycerol and amino acids in combination with lipid emulsion.

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