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Last Updated: March 26, 2026

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 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 CONTRACT PHARMACAL on October 15th, 1986.

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Questions you can ask:
  • What is the 5 year forecast for PEDIATRIC ADVIL?
  • What are the global sales for PEDIATRIC ADVIL?
  • What is Average Wholesale Price for PEDIATRIC ADVIL?
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: March 25, 2026

What is the Current Market Position of Pediatric Advil?

Pediatric Advil, manufactured by Johnson & Johnson under the label of Advil Children's Pain & Fever, holds a dominant position in the over-the-counter (OTC) pediatric analgesic segment. As of 2022, it accounts for approximately 25% of the global OTC pediatric analgesic sales, driven by brand recognition, consumer trust, and broad distribution networks.

Market Size and Revenue

  • Global OTC Pediatric Pain Relief Market (2022): Estimated at $4.5 billion.

  • Advil Pediatric Share: Estimated at $1.125 billion, representing a 25% market share.

  • Growth Rate: Projected compound annual growth rate (CAGR) of 4.0% from 2022 to 2027 (based on market reports by IQVIA).

Key Competitors

Brand Market Share (2022) Price Range (per 100 mL) Distribution Channels
Advil Pediatric 25% $8 - $12 Pharmacies, mass retail, online
Tylenol Kids 15% $7 - $11 Same as Advil
Motrin Children's 10% $9 - $13 Pharmacies, online
Store Brands 30% $5 - $9 Mass retail, online
Others 20% Varies Niche outlets

What are the Drivers of Market Growth?

  • Increased Pediatric OTC Usage: Rising parental preference for OTC medications for fever and pain management due to convenience and cost effectiveness.

  • Product Line Extensions: Johnson & Johnson expanded its pediatric analgesic offerings with formulations such as chewables, suspensions, and combination products targeting different age groups.

  • Evolving Consumer Behavior: Preference for well-known brands like Advil correlates with perceived safety, reliability, and consistent quality.

  • Regulatory Environment: Stringent regulations for pediatric OTC drugs promote trust and potentially reduce competitors' market entry.

What are the Challenges and Limitations?

  • Market Saturation: The OTC pediatric analgesic segment is mature; growth relies heavily on product innovation and consumer perception.

  • Generic Competition: Store brands and generics account for around 50% of sales, pressuring prices and margins.

  • Regulatory Pressures: Regulatory agencies impose strict safety and efficacy requirements, potentially delaying product launches or reformulations.

  • Supply Chain Disruptions: COVID-19 affected manufacturing and distribution channels, impacting availability in some regions.

What is the Financial Trajectory and Future Outlook?

Revenue Trends

  • Historical Revenue (2018-2022): Consistent growth with a CAGR of approximately 3.5%, aligned with overall market growth.

  • Estimated 2023 Revenue: Approximate sales of $1.17 billion, assuming steady market share and pricing.

  • Profit Margins: Gross margins for OTC pediatric products hover around 40-50%, subject to commodity prices and manufacturing efficiencies.

Investment Outlook

  • Johnson & Johnson continues to invest in marketing, product innovation, and supply chain improvements.

  • Potential for growth exists in emerging markets, driven by increasing urbanization and healthcare awareness.

  • Development of new formulations, such as sugar-free options and age-specific dosing, is a focus to cater to evolving consumer preferences.

Risks and Uncertainties

  • Market penetration by store brands could erode revenue.

  • Regulatory changes may impact formulations or advertising practices.

  • Competitive innovations could alter pricing dynamics.

What are the Regulatory and Patent Considerations?

  • Regulatory Status: Pediatric Advil is FDA-approved for appropriate age groups in the U.S., with regulatory filings in Europe and Asia.

  • Patents: Johnson & Johnson holds patents covering specific formulations and delivery systems; however, many patents on active ingredients have expired, enabling branded generics.

  • Legal Environment: Stringent advertising and labeling requirements in different jurisdictions influence marketing strategies.

Conclusion

Pediatric Advil maintains a strong market presence amid a mature OTC segment. Growth prospects depend on product innovation, expanding into emerging markets, and navigating competitive pressures. Continued brand strength and regulatory compliance underpin its financial stability over the next five years.


Key Takeaways

  • Pediatric Advil holds a 25% share of the pediatric OTC analgesic market, with revenues around $1.125 billion in 2022.
  • The global OTC pediatric pain relief market is growing at approximately 4% CAGR, driven by consumer demand and product extensions.
  • Competition from store brands and generics compresss margins and market share.
  • Growth opportunities exist in emerging markets and through new formulations.
  • Regulatory policies remain a critical factor influencing future product development and market access.

FAQs

1. How does Pediatric Advil differentiate from competitors?
Brand recognition, trustworthiness, and broad distribution channels distinguish Advil. Product formulations and marketing strategies focus on safety and efficacy for children.

2. What are the main regulatory hurdles?
Regulatory agencies require rigorous safety and efficacy data; some formulations face restrictions or label updates, particularly in international markets.

3. What is the impact of patent expirations?
Expired patents on active ingredients enable generic and store-brand competition, placing pricing pressure on branded products like Advil.

4. How is consumer demand shifting?
Parents prefer easy-to-administer, sugar-free, and age-specific formulations, prompting innovation from Johnson & Johnson.

5. Which emerging markets offer growth potential?
Countries in Asia-Pacific and Latin America show increasing demand for pediatric OTC products, fueled by rising healthcare awareness and urbanization.


References

  1. IQVIA (2022). OTC Pediatric Pain Relief Market Report.
  2. Johnson & Johnson (2023). Annual Report.
  3. U.S. Food and Drug Administration (FDA). OTC Drug Review.

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