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Last Updated: December 22, 2024

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) Drug Patent Profile


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Which patents cover Infuvite Pediatric (pharmacy Bulk Package), and what generic alternatives are available?

Infuvite Pediatric (pharmacy Bulk Package) is a drug marketed by Sandoz Canada Inc and is included in one NDA.

The generic ingredient in INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k profile page.

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Summary for INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
Drug patent expirations by year for INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

US Patents and Regulatory Information for INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Canada Inc INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021265-002 Jan 29, 2004 RX Yes Yes ⤷  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

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INFUVITE PEDIATRIC (Pharmacy Bulk Package)

Introduction

INFUVITE PEDIATRIC, a multivitamin formulation by Baxter, is designed for intravenous administration to prevent vitamin deficiencies in pediatric patients receiving parenteral nutrition. Understanding the market dynamics and financial trajectory of this product is crucial for stakeholders in the healthcare and pharmaceutical industries.

Market Overview

The global pediatric drugs market, which includes INFUVITE PEDIATRIC, is experiencing significant growth driven by several factors.

Market Size and Growth

The pediatric drugs market was valued at USD 28.8 billion in 2023 and is projected to grow to USD 95.4 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 12.7% during the forecast period from 2024 to 2033[4].

Segment Dominance

Hospital pharmacies dominate the distribution channel for pediatric drugs, capturing a market share of 52.7% in 2023. This dominance is attributed to hospitals being primary healthcare centers for children and their ability to accurately manage and dispense specialized pediatric formulations[4].

Indications and Usage

INFUVITE PEDIATRIC is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. It is also used in situations requiring intravenous administration, such as surgery, extensive burns, and severe infectious diseases[1][2][5].

Product Features

  • Formulation: INFUVITE PEDIATRIC is a sterile product consisting of two vials that must be combined and diluted prior to intravenous administration.
  • Pharmacy Bulk Packages: These packages are designed for high-volume pharmacy admixture programs, allowing for the preparation of multiple single doses from a single bulk package, which improves compounding efficiency[1][2].
  • Low Aluminum Content: The product contains no more than 30 mcg/L of aluminum, which is crucial for minimizing toxicity, especially in premature neonates[1][2].

Regulatory Environment

The development and approval of pediatric drugs, including INFUVITE PEDIATRIC, are influenced by regulatory frameworks such as the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). These acts expedite research and development activities and facilitate quick approvals by regulatory bodies like the FDA[4].

Competitive Landscape

The pediatric multivitamin market is part of a broader segment that includes various formulations and brands. INFUVITE PEDIATRIC competes with other intravenous multivitamin products, but its specific formulation and pharmacy bulk package configuration provide a competitive edge in high-volume pharmacy settings[1][3].

Financial Trajectory

Revenue Growth

Given the growing demand for pediatric drugs and the dominance of hospital pharmacies, INFUVITE PEDIATRIC is likely to see steady revenue growth. The overall pediatric drugs market's CAGR of 12.7% indicates a robust financial trajectory for products like INFUVITE PEDIATRIC[4].

Cost Efficiency

The pharmacy bulk package configuration of INFUVITE PEDIATRIC helps in reducing the number of physical manipulations, thereby improving compounding efficiency and potentially lowering costs for healthcare providers. This cost efficiency can contribute to higher adoption rates and increased revenue[1].

Market Opportunities

The increasing investments in research and development for pediatric drugs, coupled with new product launches and quick FDA approvals, present significant opportunities for INFUVITE PEDIATRIC. The product's approval and ongoing use in critical care settings further solidify its market position[4].

Challenges and Risks

Safety and Monitoring

INFUVITE PEDIATRIC comes with important risk information, including the potential for hypervitaminosis A, interactions with other medications like warfarin, and the need for periodic monitoring of vitamin levels, especially in patients with renal or liver disease[2][5].

Regulatory Compliance

Compliance with regulatory requirements and ongoing monitoring by regulatory bodies are essential for maintaining market approval and avoiding any adverse financial impacts.

Key Takeaways

  • Market Growth: The pediatric drugs market, including INFUVITE PEDIATRIC, is expected to grow significantly with a CAGR of 12.7% from 2024 to 2033.
  • Dominant Distribution Channel: Hospital pharmacies play a crucial role in the distribution of pediatric drugs, including INFUVITE PEDIATRIC.
  • Product Features: The pharmacy bulk package configuration and low aluminum content are key features of INFUVITE PEDIATRIC.
  • Regulatory Environment: Regulatory acts like BPCA and PREA support the development and approval of pediatric drugs.
  • Financial Trajectory: INFUVITE PEDIATRIC is likely to see steady revenue growth due to its competitive edge and the growing demand for pediatric drugs.

FAQs

What is INFUVITE PEDIATRIC used for?

INFUVITE PEDIATRIC is used as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. It is also indicated in situations requiring intravenous administration, such as surgery and severe infectious diseases[1][2][5].

What are the key features of INFUVITE PEDIATRIC?

INFUVITE PEDIATRIC is supplied as a pharmacy bulk package, contains zero preservatives, is free of natural rubber latex, and has low aluminum content. It is designed for high-volume pharmacy admixture programs[1].

How does the regulatory environment impact INFUVITE PEDIATRIC?

Regulatory acts like BPCA and PREA expedite research and development activities and facilitate quick FDA approvals, which support the market presence and growth of INFUVITE PEDIATRIC[4].

What are the potential risks associated with INFUVITE PEDIATRIC?

Potential risks include hypervitaminosis A, interactions with medications like warfarin, and the need for periodic monitoring of vitamin levels, especially in patients with renal or liver disease[2][5].

How is the market for pediatric drugs expected to grow?

The pediatric drugs market is expected to grow from USD 28.8 billion in 2023 to USD 95.4 billion by 2033, with a CAGR of 12.7% during the forecast period from 2024 to 2033[4].

What distribution channel dominates the market for pediatric drugs?

Hospital pharmacies dominate the market for pediatric drugs, capturing a valuable market share of 52.7% in 2023[4].

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