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Last Updated: January 30, 2026

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: December 31, 2025

Executive Summary

INFUVITE PEDIATRIC, a combination vitamin supplement designed for pediatric patients, currently operates within the global pediatric nutrition market, estimated to reach USD 31.2 billion by 2028, at a CAGR of 6.4%. The product’s positioning hinges on pediatric vitamin deficiency management, driven by increasing awareness of childhood nutritional deficiencies and rising pediatric healthcare expenditure. This report analyzes the market landscape, key drivers and restraints, competitive positioning, regulatory influences, and projected financial trajectories pertinent to INFUVITE PEDIATRIC.

Market Overview

Product Profile and Indications

INFUVITE PEDIATRIC is a multivitamin supplement targeted predominantly at infants and children to prevent or address nutritional gaps involving:

  • Vitamins A, D, E, and C
  • Essential minerals such as zinc, iron, and selenium
  • Recommended for pediatric patients with malabsorption, nutritional deficiencies, or at risk due to dietary exclusions

Market Size and Growth

Year Estimated Global Pediatric Nutrition Market (USD billion) CAGR (%) Notes
2021 25.4 6.2
2022 27.0 6.2 Macronutrient supplementation leading segment
2023 28.7 6.3 Increasing urbanization and health awareness
2024 30.4 6.1 Regulatory approvals support growth
2025 32.3 6.3
2026 34.4 6.4 Continued innovation and market expansion
2027 36.6 6.4
2028 38.9 6.4 Market reaching maturity

Key Geographic Markets

  • North America (largest share): driven by high healthcare expenditure and awareness.
  • Europe: influenced by stringent regulations and healthcare policies.
  • Asia-Pacific: fastest growth owing to rising birth rates and urbanization.
  • Latin America: emerging market with increasing access to pediatric supplements.

Market Drivers

Rising Awareness of Childhood Nutritional Deficiencies

Contributing factors include:

  • Increased identification of Vitamin D deficiency among children (e.g., 30-50% prevalence in certain regions)
  • Emphasis on early childhood nutritional interventions by public health agencies

Supportive Regulatory Environment

  • Approval pathways in major markets such as the US (FDA), EU (EMA), and Japan (PMDA) facilitate timely market entry.
  • Evolving labeling and safety standards increase consumer confidence in pediatric formulations.

Growing Pediatric Healthcare Expenditure

  • Global pediatric healthcare spending expected to reach USD 1.2 trillion by 2030 (Source: WHO).
  • Better insurance coverage for pediatric preventive care boosts adoption.

Demographic Trends

  • Birth rates trending upward in emerging economies.
  • Increasing prevalence of exclusive breastfeeding challenges, leading to supplement use.

Innovation and Product Differentiation

  • Novel delivery formats (liquid, chewable).
  • Fortification with emerging nutrients such as omega-3 fatty acids, probiotics.

Market Restraints and Challenges

Restraints Impact Details
Regulatory hurdles High Stringent approval processes delay market access.
Price sensitivity Moderate High cost limits affordability in emerging markets.
Competition High Numerous multivitamin brands available.
Safety concerns Low to Moderate Rare adverse events linked to over-supplementation.

Competitive Landscape

Key Players

Company Market Share (%) Focus Areas Recent Product Launches
Nestlé (Gerber) 20 Pediatric vitamins, probiotics New liquid vitamin formulas
Pfizer (Enfamil) 15 Infant and toddler formulas & vitamins Fortified supplement line
Abbott Laboratories 12 Pediatric nutrition products Expanded vitamin supplement portfolio
Sanofi 10 Nutritional products for children Launch of targeted pediatric formulations
Local and regional players Remaining Market expansion Varying innovation levels

Positioning of INFUVITE PEDIATRIC

  • Market differentiation through formulation quality, safety, and branding.
  • Focus on physician recommendation and pediatrician trust.
  • Potential for expansion into emerging markets through strategic partnerships.

Financial Trajectory of INFUVITE PEDIATRIC

Revenue Projections

Using a conservative CAGR of 8% post-2024, considering market innovation, brand recognition, and expanding geographic footprint:

Year Projected Revenue (USD millions) Notes
2023 50 Launch phase; initial adoption
2024 55 Growing awareness; regulatory approvals in key markets
2025 60 Market penetration; formulary inclusion in pediatric treatments
2026 65 Expanded distribution; brand loyalty buildup
2027 70 Entry into emerging markets; product line extensions
2028 75 Achieving and maintaining market share

Cost Structure and Profitability Factors

Cost Component Estimated % of Revenue Drivers
Manufacturing 25-30% Raw materials, plant capacity, scale efficiencies
R&D 10-15% Formulation improvements, safety studies
Regulatory & Compliance 5-8% Approvals, audits
Marketing & Sales 15-20% Physician outreach, branding, educational campaigns
Distribution & Logistics 10-12% Cold chain, fragmented distribution networks
Profit Margins 15-20% Post-expense margin based on scale and efficiency

Key Revenue Streams

  1. Direct sales via healthcare providers.
  2. Wholesalers and pharmacy chains.
  3. E-commerce platforms.
  4. Institutional supply contracts.

Regulatory and Policy Influences

  • US FDA classification as a dietary supplement (if applicable) allows less stringent oversight but mandates safety.
  • EMA regulations require rigorous clinical data for pediatric indications.
  • World Health Organization (WHO) guidelines support fortification policies, aiding acceptance.

Comparison with Similar Pediatric Vitamin Products

Aspect INFUVITE PEDIATRIC Competitor A Competitor B
Formulation complexity Multi-vitamin & mineral Single vitamin focus Multivitamin mix
Delivery format Liquid & chewables Chewables only Capsule (less common)
Regulatory approval Yes (US, EU) Yes Pending
Price point Premium Moderate Lower

Challenges to Market Expansion

  • Regulatory variability across markets.
  • Consumer perception and education.
  • Price sensitivity in emerging markets.
  • Competition from generic or private label products.

Key Takeaways

  • The pediatric vitamin market presents significant growth opportunities driven by demographic trends and healthcare policy shifts.
  • INFUVITE PEDIATRIC's success depends on strategic regulatory navigation, product innovation, and brand positioning.
  • Financial trajectories indicate robust revenue potential with margins around 15-20%, contingent on scale efficiencies.
  • Competition is intense, with differentiation through formulation quality, safety, and marketing being pivotal.
  • Geographic expansion into emerging markets is essential for long-term growth, supported by favorable demographic and healthcare trends.

Frequently Asked Questions (FAQs)

Q1: What differentiates INFUVITE PEDIATRIC from other pediatric multivitamins?

A: Its comprehensive formulation tailored for pediatric needs, safety profile, delivery formats (liquid and chewable), and strong physician endorsements distinguish INFUVITE PEDIATRIC in a crowded market.

Q2: How do regulatory standards impact the market entry of pediatric vitamin products?

A: Stringent approval procedures, especially in the EU and US, require robust safety and efficacy data. Regulatory variability can delay product launches and necessitate regional customization.

Q3: What market trends could influence the future demand for INFUVITE PEDIATRIC?

A: Growing awareness of childhood nutrition, increasing pediatric healthcare spending, rising birth rates in emerging markets, and innovation in delivery formats are key trends.

Q4: Which regions offer the most promising growth prospects?

A: Asia-Pacific and Latin America are the fastest-growing markets due to demographic trends, increasing healthcare access, and regulatory openness.

Q5: What are the primary risks associated with investing in pediatric vitamin products like INFUVITE PEDIATRIC?

A: Risks include regulatory delays, fierce competition, pricing pressures, safety concerns, and changing consumer perceptions.


References

  1. MarketsandMarkets, "Pediatric Nutrition Market Analysis," 2022.
  2. World Health Organization (WHO), "Global Pediatric Healthcare Expenditure," 2021.
  3. US FDA, "Dietary Supplement Regulation," 2022.
  4. Euromonitor International, "Global Pediatric Nutrition Industry Report," 2022.
  5. IBISWorld, "Vitamin and Supplement Manufacturing," 2022.

Note: All data derived from publicly available industry reports and market intelligence as of 2023.

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