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Last Updated: December 14, 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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Drug patent expirations by year for INFUVITE PEDIATRIC
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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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for INFUVITE PEDIATRIC

Last updated: July 30, 2025

Introduction

INFUVITE PEDIATRIC is an essential nutritional supplement designed specifically for pediatric patients, often used to address vitamin and mineral deficiencies in children with specific health needs, such as those with malnutrition, chronic illnesses, or recovery post-surgery. As a specialized multivitamin and mineral preparation, its market trajectory is defined by evolving pediatric healthcare practices, regulatory landscapes, demographic trends, and competitive forces within the broader nutritional supplement and pharmaceutical sectors.

This analysis evaluates the current market dynamics driving INFUVITE PEDIATRIC's commercial prospects, examines the factors shaping its financial trajectory, and explores future growth opportunities. It emphasizes the strategic implications for stakeholders, including manufacturers, market entrants, and healthcare providers.


Market Overview and Demand Drivers

Global Pediatric Nutritional Market Growth

The pediatric nutritional supplement market has experienced consistent growth fueled by increasing awareness of childhood nutrition, rising prevalence of malnutrition, and expanding pediatric healthcare services. According to industry reports, the global pediatric nutrition market is projected to reach approximately US$14 billion by 2027, with a CAGR of about 6% from 2020–2027 [1].

Factors contributing to this expansion include:

  • Rising pediatric chronic illnesses: Conditions like cystic fibrosis, gastrointestinal disorders, and developmental delays necessitate supplementation.
  • Growing awareness among healthcare providers and parents: Emphasis on early nutritional interventions supports demand.
  • Implementation of preventive healthcare: Governments and organizations promoting childhood nutrition bolster consumption.

Regulatory Environment and Approvals

Regulatory approvals significantly influence market entry and product sales. INFUVITE PEDIATRIC, being a prescription or specialized supplement, depends on stringent regulatory bodies such as the FDA (U.S.), EMA (Europe), or equivalents in emerging markets. These agencies emphasize safety, efficacy, and manufacturing standards, influencing the speed and cost of market penetration.

The product's compliance with pediatric safety standards enhances its market acceptance, especially in developed regions where regulatory scrutiny is higher.

Healthcare Infrastructure and Diagnostic Trends

Technological advancements, improved disease diagnostics, and pediatric screening programs lead to early identification of deficiencies requiring supplementation. Pediatric clinics increasingly recommend targeted nutritional support, directly benefiting INFUVITE PEDIATRIC’s placement in treatment protocols.

Furthermore, the rising number of pediatric healthcare facilities and specialized clinics globally expand the potential demand base.


Market Challenges and Competitive Dynamics

Competition Spectrum

INFUVITE PEDIATRIC faces competition from various multivitamin brands, both prescription-based and over-the-counter (OTC), including:

  • Established global brands like Pediasure, Poly-Vi-Flor, and Enfamil multivitamins.
  • Local and regional brands tailored to specific markets.
  • Generic formulations with similar compositions and lower prices.

The competitive landscape is fragmented, with differentiated manufacturing quality, regulatory approval status, and marketing strategies influencing market share.

Pricing Pressure and Payer Dynamics

Pediatric supplements often operate within constrained reimbursement scopes, especially when prescribed under insurance plans. Government programs and private payers scrutinize costs, leading to pricing pressures. Consequently:

  • Price sensitivity limits potential revenue growth.
  • Formulary inclusion becomes critical for stable sales.

Market Penetration and Adoption

Adoption is heavily reliant on pediatrician prescribing habits, parent acceptance, and healthcare provider recommendations. Resistance to new products, especially in regions with established brand loyalty, presents challenges.

Educational initiatives and demonstrating efficacy and safety are paramount to overcoming barriers.


Financial Trajectory Analysis

Revenue Streams

Key revenue drivers include:

  • Prescribed use in hospitals and clinics: Particularly for high-risk pediatric populations.
  • Direct retail sales: Via pharmacies and clinics.
  • Private healthcare contracts: Especially in healthcare systems with integrated pediatric care.

Revenue potential correlates with the prevalence of conditions requiring supplementation and the scope of product distribution.

Market Penetration Strategy

Successful penetration hinges on:

  • Strategic partnerships with healthcare providers.
  • Regional regulatory approval and clinical studies affirming safety/efficacy.
  • Targeted marketing emphasizing pediatric health benefits.

Pricing and Margins

Margins are influenced by:

  • Manufacturing costs: Typically higher for pediatric formulations due to quality standards.
  • Pricing strategies: Premium pricing in developed markets versus price-sensitive markets.
  • Regulatory costs: Clinical trials, quality controls, and registration expenses.

Considering the product's specialized nature, premium margins are feasible, especially in healthcare settings emphasizing quality and safety.

Forecasting the Growth Trajectory

Based on current trajectory, INFUVITE PEDIATOR’s financial outlook is optimistic with sustained growth expected over the next 5–10 years. Key factors include:

  • Expanding pediatric healthcare access in emerging markets.
  • Increased awareness of micronutrient deficiencies.
  • Potential product extensions (e.g., formulations tailored for specific conditions).

Projected Compound Annual Growth Rate (CAGR) for sales is estimated between 4-6%, aligning with general pediatric nutritional market trends [1].


Emerging Opportunities and Strategic Considerations

Innovations in Formulation and Delivery

Smart delivery systems, liquid formulations, or combination therapies could enhance adherence and expand target demographics. Personalized nutrition based on genetic or metabolic profiling remains an engaging future avenue.

Expanding Geographic Footprint

Emerging markets with rising childhood malnutrition rates present lucrative opportunities. Tailoring regulatory strategies and forming local partnerships can accelerate market entry.

Regulatory and Policy Support

Government initiatives focusing on childhood health, micronutrient deficiency eradication programs, and inclusion of pediatric supplements in national health schemes present growth enablers.

Digital and Telehealth Integration

Leveraging telemedicine platforms and digital health tracking tools can facilitate education, adherence, and monitoring, increasing product utilization.


Conclusion: Strategic Outlook

INFUVITE PEDIATRIC’s market dynamics are shaped by demographic trends, regulatory rigor, and competitive pressures. Its financial trajectory remains promising when aligned with strategic initiatives that prioritize clinical validation, regional expansion, and stakeholder engagement.

Manufacturers should focus on differentiating through safety profiles, clinical evidence, and targeted marketing. Moreover, sustaining partnerships with pediatrics and primary care providers is crucial to expanding utilization.

Over the next decade, the intersection of technological innovation, evolving healthcare policies, and demographic shifts will underpin INFUVITE PEDIATRIC’s growth potential, establishing it as a vital component in pediatric nutritional management.


Key Takeaways

  • The pediatric nutritional market is poised for steady growth, driven by increased health awareness and therapeutic needs.
  • INFUVITE PEDIATRIC’s success depends on regulatory approvals, competitive positioning, and strategic clinical validation.
  • Pricing strategies must balance premium margins with affordability, especially in price-sensitive markets.
  • Expanding into emerging markets offers significant growth opportunities, contingent on tailored regulatory and market-entry strategies.
  • innovation in formulation, digitization, and partnerships will be pivotal in driving future sales and market share.

FAQs

  1. What distinguishes INFUVITE PEDIATRIC from other pediatric multivitamins?
    Its formulation is specifically designed considering pediatric safety profiles, targeted nutrient composition, and approved clinical indications, positioning it as a trusted treatment adjunct in clinical settings.

  2. How does regulatory approval impact INFUVITE PEDIATRIC’s market access?
    Strict adherence to pediatric safety standards and comprehensive clinical data are essential for approval, which directly influences market entry speed and product acceptance.

  3. What are the key challenges facing INFUVITE PEDIATRIC’s market growth?
    Challenges include intense competition from established brands, price sensitivities in certain markets, regulatory hurdles, and clinician and parent acceptance.

  4. Which regions present the highest growth potential for this product?
    Emerging markets in Asia-Pacific, Latin America, and Africa offer high growth potential due to rising malnutrition rates and expanding healthcare infrastructure.

  5. What strategies can companies adopt to enhance INFUVITE PEDIATRIC’s market performance?
    Strategies include clinical validation, regional regulatory navigation, stakeholder education, forming strategic alliances, and leveraging digital health tools.


Sources
[1] MarketsandMarkets. "Pediatric Nutrition Market by Product Type, Application, and Region — Global Forecast to 2027."

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