Last Updated: May 13, 2026

ADVIL Drug Patent Profile


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

Advil is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. There are two patents protecting this drug.

The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

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Summary for ADVIL
Pharmacology for ADVIL

US Patents and Regulatory Information for 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 ADVIL ibuprofen TABLET;ORAL 018989-001 May 18, 1984 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL CONGESTION RELIEF ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022565-001 May 27, 2010 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 021441-001 Dec 19, 2002 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733-001 Feb 28, 2020 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Haleon Us Holdings ADVIL ibuprofen sodium TABLET;ORAL 201803-001 Jun 12, 2012 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL ALLERGY AND CONGESTION RELIEF chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022113-001 Dec 21, 2011 OTC Yes Yes ⤷  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 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

Advil (ibuprofen) Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is Advil’s commercial profile in the drug market?

Advil is an over-the-counter (OTC) brand of ibuprofen, a widely used nonsteroidal anti-inflammatory drug (NSAID) indicated for pain and fever. The brand’s market dynamics are shaped by (1) mature off-patent status, (2) high substitution into generics and store brands, (3) strong distribution through mass retail and pharmacy channels, and (4) recurring demand tied to seasonal illness patterns and chronic pain prevalence.

Core commercial facts that drive Advil’s dynamics

  • Active ingredient: ibuprofen
  • Category: OTC NSAID
  • Positioning: consumer pain relief and fever reduction across common indications (headache, minor aches, fever), with dosing formats aligned to OTC purchase behavior.
  • Competitive set: ibuprofen generics, store brands, and competing OTC NSAIDs (where available) plus adjacent OTC pain/fever classes (acetaminophen and topical/combination products).

How do generics and OTC substitution affect Advil pricing and margins?

Advil operates in a market structure where generic ibuprofen is legal competition in essentially all major geographies where ibuprofen has matured off-patent. That creates persistent pressure on:

  • Net price and gross margin: brand pricing must stay close enough to generics to maintain volume, especially in high-pull retail formats.
  • Promotional intensity: retailers and wholesalers negotiate price and placement around seasonal peaks (cold and flu season, summer injury-driven usage).
  • Share shifts: small promotional advantages and package-size differences can drive measurable unit swings because consumers trade down to lower-priced equivalents.

Implications for financial trajectory

  • Revenue growth is largely volume-led and depends on brand retention through advertising, pack architecture, and retail execution.
  • Profitability tracks promotional and input-cost cycles, not innovation.

What demand forces move AdviI sales through the year?

Advil’s sales are exposed to recurring consumer behavior patterns:

  • Seasonality: higher OTC fever and pain demand during respiratory infection seasons.
  • Weather and activity mix: summer travel and injuries, winter weather-related musculoskeletal discomfort.
  • Public health behavior: sustained OTC use during peak illness months.
  • Household replenishment cadence: OTC NSAID users buy in repeating windows rather than one-time therapy.

These drivers typically produce:

  • Cyclic revenue bands (peaks and troughs) rather than smooth growth.
  • Stable underlying demand due to chronic and episodic pain recurrence, offset by periodic discounting cycles.

How does retail channel structure shape Advil distribution outcomes?

Advil is primarily sold through channels that emphasize:

  • High throughput SKU coverage (liquid caps, tablets, pediatric formulations where applicable, and targeted pack sizes).
  • Retail planogram and promotional calendars (slotting and end-cap exposure).
  • Wholesale replenishment discipline that manages inventory and avoids stock-outs ahead of seasonal peaks.

Channel-level dynamics

  • Mass retail and warehouse clubs: high private-label substitution risk; share depends on promotion depth and pack value.
  • Pharmacy chains: stronger brand equity carryover; loyalty programs can sustain unit demand versus private label.
  • E-commerce: price sensitivity increases; brand differentiation depends on fulfillment speed, bundle pricing, and authorized seller controls.

What competition matters most for Advil performance?

Competition is not a single competitor; it is a portfolio of substitution options:

Direct substitution

  • Generic ibuprofen and store brands.
  • OTC ibuprofen in comparable dosage forms (tablets, caplets, liquid gels where offered).

Indirect substitution

  • Acetaminophen for pain/fever where consumers prefer or are advised against NSAIDs.
  • Combination products (where available) that compete for “one purchase per symptom” behavior.
  • Topicals and non-drug remedies that can absorb some minor pain use.

Why this matters financially

  • In OTC mature markets, market share is won by cost-effective reach rather than differentiation.
  • Financial trajectory depends on whether the brand can hold share during promotional downtrends while preserving sufficient pricing.

How does regulation and safety messaging affect consumer adoption?

Ibuprofen’s OTC status is supported by established labeling and safety requirements. Over time, consumer purchasing is influenced by:

  • Boxed/label safety guidance for GI and cardiovascular risk tradeoffs.
  • Age and dosing restrictions (especially for pediatric use).
  • Prescriber and pharmacist counseling in pharmacy channels that can steer consumers toward or away from NSAIDs.

In financial terms:

  • Safety messaging can shift mix (adult vs pediatric, strength selection, dosing form preferences).
  • It can also influence category elasticity, where certain segments buy less frequently or switch to acetaminophen.

What does a “mature OTC” lifecycle imply for Advil’s financial path?

Advil fits a mature OTC lifecycle:

  • No patent-driven monopoly pricing
  • Ongoing brand spend to defend share
  • Margin influenced by promotional intensity and retailer power
  • Revenue growth tied to macro-consumer pain and illness incidence, plus share defense

In mature OTC, typical financial behavior is:

  • Revenue: tends to track category growth and promotional-driven unit movement.
  • Operating profit: depends on gross margin and brand/marketing spend efficiency.
  • Earnings volatility: rises in periods of heavier promotion or adverse input-cost conditions; declines when demand is stable and promotion is lighter.

Key financial trajectory expectations for Advil (pattern-based)

Without company-specific filings provided here, the market-typical trajectory for a mature OTC ibuprofen brand is:

Revenue

  • Stable to modest growth over long cycles, driven by:
    • Seasonal peaks
    • Pack-size and formulation migration (when executed)
    • Occasional share gains during competitor weakness or heavier brand promotion

Margins

  • Gross margin compresses when:
    • Price promotions increase
    • Retailers demand higher discounts
    • Trade spend rises

Profitability

  • Operating income growth lags revenue growth because sustaining brand equity requires marketing investment even after maturity.

Cash flow

  • OTC volume stability supports:
    • Lower working-capital stress than specialty products
    • Predictable supply-chain utilization

What signals would investors/strategists track for Advil’s near-term outlook?

For a brand like Advil, the actionable signals are usually channel and category, not clinical pipeline milestones:

  1. Retail price index vs generic ibuprofen (brand premium and trade-down behavior)
  2. Promotion calendar intensity in major retailers and clubs
  3. Unit share vs store brand during peak winter and respiratory seasons
  4. Mix shift across dosage forms (adult caplets vs pediatric liquids and strengths)
  5. E-commerce price tracking for authorized listings and bundle pricing
  6. Regulatory or label updates affecting OTC eligibility or dosing advice

Market dynamics summary table (how they translate into financial impact)

Driver Market Mechanism Expected Financial Effect
Generic and private label competition Price substitution and share drift Lower net price; revenue relies on volume and promotion efficiency
Seasonality (illness and activity) Cyclical category demand Revenue volatility by quarter; higher working-capital swings ahead of peaks
Retail channel power Slotting, trade discounts, end-cap control Margin pressure during discounting; improved margins in controlled promotion periods
Brand spend for share defense Consumer awareness and shelf recall Operating margin discipline required to sustain earnings
Safety/label messaging Consumer segment steering and dosing behavior Mix effects; potential demand shifts within OTC NSAID category

Key Takeaways

  • Advil’s financial trajectory is driven by OTC category demand and share defense, not innovation or patent protection.
  • Generics and store brands cap pricing power, so brand performance depends on promotion discipline, channel execution, and mix management.
  • Seasonality and retailer promotional calendars are the primary short-term volatility sources for revenue and earnings.
  • Investor-grade monitoring should focus on price-value tracking versus generic ibuprofen, unit share vs private label, and margin impact from trade spending.

FAQs

  1. Is Advil primarily a prescription or OTC product?
    Advil is an OTC ibuprofen brand.

  2. What is the biggest structural risk to Advil’s revenue growth?
    Substitution into generic ibuprofen and store brands, which limits pricing power and makes share defense execution-critical.

  3. What creates the most seasonality in Advil sales?
    Respiratory illness season increases fever and pain purchasing, and weather-driven activity patterns also shift OTC demand.

  4. How does competition show up for Advil besides generics?
    Indirect substitution occurs versus acetaminophen and other OTC pain/fever options, plus topical and combination products that can capture symptom-driven purchases.

  5. What metrics best predict Advil’s near-term profitability?
    Net pricing versus generic ibuprofen, promotional intensity, unit share vs private label, and trade/marketing spend efficiency.


References

[1] FDA. “Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).” U.S. Food and Drug Administration.
[2] National Library of Medicine. “Ibuprofen.” PubChem.
[3] IQVIA Institute / IMS data reporting on OTC market structure and seasonality (general OTC market dynamics).

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