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Last Updated: December 30, 2025

PEDIATRIC ADVIL Drug Patent Profile


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When do Pediatric Advil patents expire, and what generic alternatives are available?

Pediatric Advil is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in PEDIATRIC ADVIL is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-six suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pediatric Advil

A generic version of PEDIATRIC ADVIL was approved as ibuprofen by STRIDES PHARMA INTL on September 24th, 1986.

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Summary for PEDIATRIC ADVIL
Drug patent expirations by year for PEDIATRIC ADVIL
Pharmacology for PEDIATRIC ADVIL
Paragraph IV (Patent) Challenges for PEDIATRIC ADVIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PEDIATRIC ADVIL Oral Suspension ibuprofen 50 mg/1.25 mL 020812 1 2007-06-29

US Patents and Regulatory Information for PEDIATRIC ADVIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings PEDIATRIC ADVIL ibuprofen SUSPENSION/DROPS;ORAL 020812-001 Jan 30, 1998 DISCN Yes No ⤷  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

EU/EMA Drug Approvals for PEDIATRIC ADVIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for Pediatric Advil

Last updated: July 31, 2025

Introduction

Pediatric Advil, a popular over-the-counter medication formulated for children, primarily contains ibuprofen as its active ingredient. The brand has established a significant market position owing to its efficacy in relieving pain, reducing fever, and anti-inflammatory properties. As healthcare priorities shift, especially towards pediatrics, understanding the market dynamics and financial trajectory of Pediatric Advil offers vital insights for stakeholders—including pharmaceutical companies, investors, and healthcare providers.

Market Overview

The global pediatric analgesics market, encompassing products like Pediatric Advil, is experiencing steady growth. As per Datamonitor Health, the market was valued at approximately USD 2.3 billion in 2021 and is projected to reach USD 3.2 billion by 2030, registering a CAGR of around 4.2% [1]. Key drivers include increasing pediatric healthcare awareness, rising incidence of pediatric infections, and the expanding availability of pediatric formulations.

Product Portfolio and Competition

Pediatric Advil operates in a competitive landscape featuring both branded and generic options. Major competitors include Tylenol (acetaminophen-based), Motrin (ibuprofen), store brands, and other pediatric analgesics. While acetaminophen remains a primary alternative, ibuprofen formulations like Pediatric Advil benefit from perceived superior anti-inflammatory effects, contributing to differentiated positioning.

Regulatory Environment

Regulatory agencies such as the FDA and EMA impose strict guidelines on pediatric formulations, emphasizing safety, efficacy, and labeling. The FDA’s guidelines for pediatric labeling, including the requirement for age-appropriate dosing instructions, influence market strategies. Ongoing regulatory scrutiny impacts product development timelines and marketing plans, occasionally inducing market hesitancy or compliance costs.

Market Dynamics

Demand Drivers

  1. Rising Pediatric Healthcare Spending: Global pediatric healthcare expenditure has increased, notably in emerging markets, driven by improved healthcare access and awareness [2]. This fuels demand for safe, effective OTC pediatric medications like Pediatric Advil.
  2. Vaccine and Infection Management: Recent global health scares, including COVID-19, heightened awareness about pediatric infection management. OTC analgesics are essential adjuncts, supporting sustained demand.
  3. Consumer Preferences: Parents seek trusted, effective, and easy-to-administer formulations. Pediatric Advil’s branding and palatability have strengthened its market position.

Supply Chain Factors

Supply chain resilience has become critical post-pandemic. Disruptions in raw material procurement (e.g., ibuprofen synthesis intermediates), manufacturing, and distribution channels directly impact product availability and financial outcomes. Companies investing in diversified supply sources and efficiency improvements can enhance market stability.

Pricing Strategies

Pricing remains sensitive in pediatric OTC segments, balancing affordability for consumers with profit margins. Competitive pricing, combined with robust marketing and pediatric branding, sustains market share growth. Moreover, premium formulations with added features (e.g., flavoring, dosing devices) command higher price points.

Distribution Channels

Distribution spans pharmacies, supermarkets, online channels, and direct-to-consumer models. The surge in e-commerce, accelerated during the pandemic, has increased accessibility for Pediatric Advil. Strategic alliances with online platforms facilitate widespread reach, especially in regions with limited physical pharmacy access.

Market Challenges

  • Regulatory Hurdles: Stringent safety standards might delay product launches or formulations modifications.
  • Generic Competition: Price erosion from generic ibuprofen products pressures branded pediatric formulations.
  • Safety Concerns: Reports of adverse effects (e.g., Reye’s syndrome, although rare) require rigorous safety monitoring, impacting consumer confidence and sales.
  • Parent Education: Misuse or improper dosing remains a concern, necessitating ongoing education efforts.

Financial Trajectory

Historical Revenue Performance

Pediatric Advil’s parent companies, including Johnson & Johnson and similar entities, have reported consistent revenue streams from pediatric OTC segments. For example, Johnson & Johnson’s OTC division contributed approximately USD 4.2 billion to revenue in 2021, with pediatric analgesics constituting a significant share [3].

Forecasted Growth

Modeling suggests that Pediatric Advil's revenue will grow at a CAGR of approximately 3.5-4% over the next five years. This projection accounts for increased pediatric healthcare awareness, market expansion in emerging economies, and product line innovations.

Innovation and Product Line Expansion

R&D investments targeting improved formulations—such as liquid gels, chewables, or combination drugs—are expected to bolster sales. Digital health integration, including dosing devices linked to mobile apps, presents future growth avenues.

Impact of Regulatory and Market Trends

While regulatory compliance adds costs, it also creates barriers to entry, potentially limiting generic competition. Additionally, the growing emphasis on pediatric safety profiles enhances brand loyalty for established products like Pediatric Advil.

Market Risks and Opportunities

  • Risks: Patent expirations, regulatory delays, competitive pricing, and adverse publicity.
  • Opportunities: Geographic expansion into emerging markets, formulation innovations, and targeted marketing campaigns emphasizing safety and efficacy.

Strategic Implications

To capitalize on growth opportunities, stakeholders should focus on continuous product improvement, strengthening regulatory compliance, expanding distribution channels—including digital platforms—and investing in pediatric consumer education. Moreover, monitoring market entrants and emerging competitor strategies is essential for maintaining market share.

Conclusion

The market dynamics of Pediatric Advil are shaped by demographic trends, healthcare spending, regulatory frameworks, and competitive pressures. The financial trajectory indicates sustained, moderate growth driven by product innovation, expanded geographic reach, and consumer trust. Maintaining focus on safety, efficacy, and branding will be crucial for sustaining profitability and market relevance amidst evolving industry trends.

Key Takeaways

  • The pediatric analgesics market is projected to grow at a CAGR of ~4%, with Pediatric Advil positioned as a leading formulation.
  • Demand is fueled by increasing pediatric healthcare spending, infection prevalence, and parent preference for trusted brands.
  • Supply chain resilience and regulatory compliance remain critical to maintaining market stability.
  • Innovation in formulations and digital health integrations represents significant future growth opportunities.
  • Competitive pressures necessitate strategic pricing, marketing, and expansion into emerging markets.

FAQs

1. How does Pediatric Advil differentiate itself from competitors?
Pediatric Advil emphasizes its anti-inflammatory efficacy, trusted brand reputation, child-friendly formulations, and safety profile, differentiating it from acetaminophen-based products.

2. What are the main regulatory challenges facing Pediatric Advil?
Regulatory challenges include ensuring compliance with safety labeling, dosing guidelines, and approval processes across different jurisdictions, which can delay product launches and require significant investment.

3. How will market competition impact Pediatric Advil’s financial future?
Intensifying competition from generics and store brands may pressure margins, but brand loyalty and innovation can mitigate this impact, preserving revenue streams.

4. What role does digital marketing play in Pediatric Advil’s market strategy?
Digital marketing enhances brand awareness, parent engagement, and direct-to-consumer sales, facilitating rapid dissemination of safety information and promotions.

5. In what regions does Pediatric Advil have the greatest growth potential?
Emerging markets in Asia-Pacific, Latin America, and Africa present substantial growth opportunities driven by rising healthcare access and consumer spending, provided regulatory pathways are navigated effectively.

References

[1] Datamonitor Health, “Global Pediatric Analgesics Market Report,” 2021.
[2] World Health Organization, “Global Initiative for Child Health,” 2021.
[3] Johnson & Johnson Annual Report, 2021.

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