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Last Updated: January 9, 2025

INFUVITE PEDIATRIC Drug Patent Profile


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When do Infuvite Pediatric patents expire, and when can generic versions of Infuvite Pediatric launch?

Infuvite Pediatric is a drug marketed by Sandoz Canada Inc and is included in one NDA.

The generic ingredient in INFUVITE PEDIATRIC 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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US Patents and Regulatory Information for INFUVITE PEDIATRIC

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 ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021265-001 Feb 21, 2001 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for INFUVITE PEDIATRIC

Introduction to INFUVITE PEDIATRIC

INFUVITE PEDIATRIC is a multiple vitamins injection indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. It is a sterile product consisting of two vials, each containing a specific set of vitamins essential for maintaining the body's normal resistance and repair processes[2][4][5].

Market Context: Pediatric Drugs Market

The global pediatric drugs market is experiencing significant growth, driven by increasing healthcare needs and advancements in medical technology. As of 2023, the pediatric drugs market was valued at USD 28.8 billion 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[3].

Demand Drivers for INFUVITE PEDIATRIC

Growing Need for Pediatric Care

The increasing incidence of preterm births, intrapartum complications, and infectious diseases such as diarrhea, malaria, and pneumonia among children under the age of five are major drivers for the demand of pediatric drugs, including INFUVITE PEDIATRIC. According to UNICEF, approximately 5.2 million children under the age of five were anticipated to die in 2020, highlighting the critical need for effective pediatric treatments[3].

Regulatory Support

The implementation of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) has expedited research and development activities related to pediatric drugs. These regulations have led to increased investments in R&D and quicker FDA approvals, fostering the growth of the pediatric drug market, including products like INFUVITE PEDIATRIC[3].

Market Segmentation and Share

Type Analysis

Respiratory disorder drugs dominate the pediatric drugs market with a 39.4% market share in 2023. While INFUVITE PEDIATRIC is not specifically categorized under respiratory disorders, its role in maintaining overall health and preventing vitamin deficiencies makes it a crucial component in the broader pediatric care segment[3].

Route of Administration

The oral route segment dominates the market with a 48.7% share, but intravenous infusions like INFUVITE PEDIATRIC are essential for patients requiring parenteral nutrition, particularly in critical care situations such as surgery, extensive burns, and severe infectious diseases[3].

Distribution Channel

Hospital pharmacies lead the market for pediatric drugs, capturing a significant market share of 52.7% in 2023. INFUVITE PEDIATRIC, being a product used in hospital settings for parenteral nutrition, benefits from this distribution channel dominance[3].

Financial Trajectory

Market Size and Growth

While the specific financial figures for INFUVITE PEDIATRIC are not publicly disclosed, the overall growth of the pediatric drugs market indicates a favorable financial trajectory. The market's projected growth from USD 28.8 billion in 2023 to USD 95.4 billion by 2033 suggests that products like INFUVITE PEDIATRIC will see increased demand and potentially higher revenues[3].

Supply Chain and Allocation

Historically, there have been supply chain challenges, such as allocation limitations for INFUVITE PEDIATRIC, particularly for the pediatric formulation. However, efforts to improve supply and allocation, such as those made by Baxter Healthcare Corporation, have helped stabilize the availability of these critical vitamins[1].

Competitive Landscape

The pediatric drugs market is competitive, with various players developing innovative treatments, including new formulations of existing drugs and gene therapies. The approval of drugs like RUZURGI (amifampridine) under priority review and fast track designations by the FDA highlights the dynamic and competitive nature of this market[3].

Regulatory Considerations

INFUVITE PEDIATRIC is subject to strict regulatory oversight, particularly given its use in vulnerable populations such as infants and children. The FDA's guidelines and the product's labeling emphasize the need for careful administration, monitoring of blood vitamin concentrations, and caution when used in conjunction with other medications like warfarin[2][4].

Innovative Treatments and Compliance

There is a surge in the development of innovative pediatric treatments that improve compliance and outcomes. INFUVITE PEDIATRIC, with its formulation designed for intravenous infusion, contributes to this trend by providing a necessary and convenient way to maintain vitamin levels in pediatric patients receiving parenteral nutrition[3].

Key Takeaways

  • Growing Market: The pediatric drugs market is expected to grow significantly, driven by increasing healthcare needs and regulatory support.
  • Critical Need: INFUVITE PEDIATRIC addresses a critical need for vitamin supplementation in pediatric patients receiving parenteral nutrition.
  • Regulatory Environment: Strict regulatory oversight ensures the safe and effective use of INFUVITE PEDIATRIC.
  • Supply Chain: Efforts to improve supply and allocation are crucial for maintaining the availability of INFUVITE PEDIATRIC.
  • Competitive Landscape: The market is competitive, with a focus on innovative treatments and improved compliance.

FAQs

Q: What is INFUVITE PEDIATRIC used for? A: INFUVITE PEDIATRIC is used as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition[2][4].

Q: What are the key ingredients in INFUVITE PEDIATRIC? A: The key ingredients include vitamins A, D, E, K, and various B vitamins, along with other essential nutrients[2][4][5].

Q: What are the potential side effects of INFUVITE PEDIATRIC? A: Potential side effects include hypervitaminosis A, interference with urine glucose testing, and antagonism of the anticoagulant action of warfarin[2][4].

Q: How is INFUVITE PEDIATRIC administered? A: It is administered intravenously after dilution in dextrose or saline solution, with specific dosage volumes based on the patient's weight[5].

Q: What regulatory acts support the development of pediatric drugs like INFUVITE PEDIATRIC? A: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) support the development and approval of pediatric drugs[3].

Sources

  1. Baxter Customer Letter: Allocation of INFUVITE Single-dose Multivitamin Injections.
  2. FDA Label: INFUVITE PEDIATRIC (multiple vitamins injection), for intravenous use.
  3. Market.us Report: Pediatric Drugs Market Growth Analysis.
  4. FDA Label: INFUVITE PEDIATRIC - multiple vitamins.
  5. Drugs.com: Infuvite Pediatric Dosage Guide.

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