Last Updated: May 10, 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-three 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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Summary 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

PEDIATRIC ADVIL Market Analysis and Financial Projection

Last updated: April 25, 2026

PEDIATRIC ADVIL: Market Dynamics and Financial Trajectory

What is “Pediatric Advil” in market terms?

Pediatric Advil” is the consumer-facing brand name for ibuprofen products formulated and marketed for pediatric use (typically oral suspension and related pediatric presentations, plus equivalent store-brand competition). In commercial and competitive analysis, the relevant value pool is the OTC pediatric pain/fever ibuprofen segment, with demand driven by:

  • seasonal respiratory illness peaks (fall to winter),
  • school-age and daycare illness cycles,
  • consumer substitution between ibuprofen and acetaminophen (Tylenol) for similar indications (fever, pain).

Drug class: NSAID, ibuprofen.
Therapeutic category (OTC): pediatric fever and pain relief.

How do market dynamics shape unit demand and pricing?

The pediatric OTC antipyretic-analgesic market is characterized by high substitutability, frequent promo cycles, and private label pressure. For “Pediatric Advil,” the main dynamics are:

1) Seasonality and incidence-driven pull

Demand is concentrated in periods with elevated fever cases from viral infections. Retail and pharmacy channel replenishment patterns typically show:

  • increased velocity in Q4 through Q1,
  • volatility tied to winter severity and school attendance patterns.

The financial impact is direct: higher seasonal volume supports manufacturer revenue growth even when net pricing erodes.

2) Substitution between ibuprofen and acetaminophen

Ibuprofen competes head-to-head with acetaminophen-based pediatric OTC products on:

  • perceived efficacy for fever and pain,
  • dosing convenience and family habits,
  • safety messaging (parents often choose based on prior experience and brand trust).

Net effect on “Pediatric Advil”:

  • share is contestable even when the category expands,
  • pricing is disciplined because families switch brands during promotions.

3) Channel structure and private label

Shelf-level competition includes:

  • branded ibuprofen suspension products,
  • store brands and relabeled equivalents at lower price points.

Typical consequence:

  • branded volumes persist through brand recognition and clinical familiarity,
  • but branded net revenue growth depends on maintaining share while private label compresses price.

4) Regulatory and labeling friction is limited but operationally real

Because ibuprofen is an established OTC molecule, regulation is stable. The cost pressure is less about approval risk and more about:

  • label compliance across formulations,
  • distribution of pediatric dosing accuracy,
  • adverse event reporting obligations that affect marketing and manufacturing scrutiny.

The commercial implication: brand spend is shaped by safety and claims substantiation requirements, not by ongoing product approvals.

5) Switching between formulations

“Pediatric Advil” exists in multiple OTC packaging formats (commonly oral suspension). Formulation and package size shifts affect:

  • price per unit,
  • pharmacy shelf turns,
  • retailer preference and planogram outcomes.

When retailers rebundle or emphasize particular pack sizes during high-velocity seasons, branded revenue can rise without major brand share gains.

What does the competitive landscape imply for pricing and gross margin?

For branded pediatric OTC ibuprofen, financial outcomes typically balance between:

  • promo intensity during peak season (driving volume but lowering net price),
  • mix shift between higher and lower price pack sizes,
  • retailer reimbursement and slotting arrangements (affecting net revenue),
  • private label pressure (limiting ability to raise net price).

Given the mature status of ibuprofen, most “trajectory” outcomes come from share and mix rather than major therapeutic differentiation.

How does OTC demand translate into a financial trajectory?

Without a specific consolidated revenue dataset for “Pediatric Advil” as a standalone product line, the financial trajectory is best mapped using the mechanics of pediatric OTC ibuprofen:

Base-case trajectory pattern

A typical mature OTC trajectory for a long-standing pediatric ibuprofen brand looks like:

  1. Steady-to-volumetric growth in peak seasons
    • Revenue rises with category incidence and store order velocity.
  2. Net price compression during promotional cycles
    • Revenue per unit declines unless the brand maintains premium pricing through loyalty and distribution strength.
  3. Share stabilization with periodic swings
    • Share can improve when competitors underperform or during aggressive manufacturer trade programs.
  4. Long-run category growth capped by household adoption
    • OTC analgesic adoption is already widespread, limiting sustained double-digit growth absent major dosing or formulation changes.

Key financial levers

  • Volume (units): driven by seasonality and retailer inventory strategy.
  • Net revenue (price net of trade): pressured by private label and competitive promos.
  • Gross margin: affected by input costs and contract manufacturing/distribution economics, but in OTC mature products gross margin tends to be stable with offsets from trade and mix.
  • Operating expense: maintained at levels supporting seasonal marketing, retailer programs, and compliance.
  • Working capital: receivables and payables tied to seasonal shipments can shift cash conversion during peak periods.

What market events could move Pediatric Advil’s trajectory?

The OTC ibuprofen category moves when specific retail and competitive actions occur. For “Pediatric Advil,” the most material event types are:

Retail trade intensity shifts

  • increased retailer promotions for ibuprofen during cold and flu spikes,
  • shifts in planogram allocation between ibuprofen and acetaminophen products.

Competitive product execution

  • competitor pricing aggressiveness,
  • stock availability (temporary supply constraints can shift temporary share and revenue).

Formulation or packaging adjustments

  • pack size changes,
  • dosing device updates,
  • changes that impact parent perception and dosing compliance.

Safety and public messaging

Even when the active ingredient is mature, public attention on pediatric dosing accuracy and safe use can swing parent behavior between ibuprofen and acetaminophen and affect retailer ordering.

Financial trajectory indicators investors use for OTC pediatric brands

For a brand like “Pediatric Advil,” business professionals typically monitor:

  • Category velocity in pediatric antipyretic-analgesic shelves
  • Brand share vs. private label
  • Net price realization after trade and promotions
  • Mix of pack sizes (higher unit price SKUs vs. budget SKUs)
  • Seasonal gross margin volatility tied to promotional intensity
  • Distribution footprint and out-of-stocks

The “trajectory” is usually observable as:

  • stable baseline volume with predictable seasonal revenue peaks,
  • periodic net price resets due to promo cycles.

Bottom-line view: what does the market dynamic do to money over time?

For “Pediatric Advil,” the financial trajectory is most likely to show:

  • revenue moving with category seasonality,
  • net revenue per unit trending flat to slightly down in the long run as private label and OTC competitors pressure pricing,
  • growth driven by share and mix, not by new clinical differentiation.

In practice, this makes the brand resemble a seasonal revenue engine with recurring competitive resets each winter.

Key Takeaways

  • “Pediatric Advil” is an OTC pediatric ibuprofen brand; demand tracks fever and pain incidence and is highly substitutional versus acetaminophen.
  • Market growth is constrained by maturity and dominated by private label and promotional pricing cycles.
  • The financial trajectory is expected to be seasonal, with revenue peaks in winter and net pricing pressure moderated by share stability and pack-size mix.
  • The levers that move financial performance are volume (seasonality and distribution), net price realization (trade and promos), and mix (pack sizes).

FAQs

1) Is Pediatric Advil growth driven by new clinical differentiation?

No. OTC ibuprofen is mature; performance is driven primarily by category seasonality, retail execution, and competitive pricing.

2) What competitor category most impacts Pediatric Advil revenue?

Acetaminophen-based pediatric OTC fever and pain products (commonly branded as Tylenol and related equivalents).

3) Why does net pricing fluctuate for pediatric OTC brands?

Retail promotions, trade allowances, and private label pressure compress net price during peak selling periods.

4) What product variable most affects revenue without changing the active ingredient?

Pack size and formulation presentation (such as oral suspension format and unit count), which change mix and net revenue per unit.

5) What metric best signals whether the brand is gaining share?

Brand volume share relative to private label plus sustained distribution availability (low out-of-stocks) during peak season.


References

[1] American Society of Health-System Pharmacists. Ibuprofen: Drug Information. ASHP.
[2] FDA. OTC Drug Facts Labeling for Ibuprofen/Antipyretic Analgesics. U.S. Food and Drug Administration.
[3] National Center for Health Statistics. Seasonal influenza and respiratory illness trends (public health surveillance). CDC/NCHS data portals.

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