Last Updated: May 10, 2026

ADVIL PM Drug Patent Profile


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Which patents cover Advil Pm, and when can generic versions of Advil Pm launch?

Advil Pm is a drug marketed by Haleon Us Holdings and is included in two NDAs.

The generic ingredient in ADVIL PM 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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  • What is the 5 year forecast for ADVIL PM?
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Summary for ADVIL PM
Paragraph IV (Patent) Challenges for ADVIL PM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADVIL PM Tablets diphenhydramine citrate; ibuprofen 200 mg/38 mg 021394 1 2017-12-28
ADVIL PM Capsules diphenhydramine hydrochloride; ibuprofen 200 mg/25 mg 021393 2016-02-16

US Patents and Regulatory Information for ADVIL PM

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 PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 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

Expired US Patents for ADVIL PM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ADVIL PM

See the table below for patents covering ADVIL PM around the world.

Country Patent Number Title Estimated Expiration
Japan 2009203243 TREATMENT OF SLEEP DISTURBANCE ⤷  Start Trial
World Intellectual Property Organization (WIPO) 02056877 ⤷  Start Trial
Austria 309797 ⤷  Start Trial
Japan 4402882 ⤷  Start Trial
Spain 2251584 ⤷  Start Trial
Denmark 1363608 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Advil PM (OTC ibuprofen + diphenhydramine) — Market dynamics and financial trajectory

Last updated: April 24, 2026

Advil PM is an over-the-counter (OTC) combination product that pairs ibuprofen (NSAID) with diphenhydramine (H1 antihistamine/sedating) for short-term relief of pain plus sleep disturbance. Financial trajectory and market dynamics for this drug class are driven by (1) OTC traffic and shelf share, (2) competitive switching across pain relief and sleep aid categories, (3) regulatory and formulation constraints that shape substitution, and (4) pricing and promotional intensity in the consumer health retail channel.

Because AdviI PM is marketed as a branded OTC product, its performance is best read through consumer health brand/segment reporting, retail scan trends, and category-leading intelligence rather than through clinical-trial or prescription-claim datasets.

What market dynamics govern Advil PM’s demand?

Category structure and buying intent

Advil PM sits at the intersection of two purchase motives:

  • Pain relief (headache, minor aches, muscle pain) attributed to ibuprofen
  • Sleep assistance (sleep-onset disturbance) attributed to diphenhydramine

That dual intent lowers pure “one-to-one” cross-elasticity with single-agent ibuprofen brands and increases overlap with:

  • OTC sleep aids (diphenhydramine-based and doxylamine-based)
  • OTC pain relievers (other NSAIDs and acetaminophen)
  • “Nighttime” branded combinations that bundle pain relief with a sedating antihistamine

In practice, the consumer behavior is retail-channel specific: shoppers often trade down across brands when promotions compress pricing, and they trade within “nighttime pain/sleep” formulations when they value the sedating component.

Retail channel and promotional economics

OTC brands typically monetize through:

  • Planogram position and shelf facings
  • Promotional frequency and depth (couponing, multi-pack pricing, retailer media placements)
  • Seasonality tied to cold/flu season, holiday travel, and winter weather-driven aches

For “nighttime” products, demand also shifts with:

  • New year and sleep-regulation campaigns
  • Weather and stress-driven increases in minor pain complaints
  • Retail readiness (inventory availability and out-of-stock events)

Competitive set

Competitive pressure comes from three directions:

  1. Generic ibuprofen: reduces the pricing premium available to branded ibuprofen-based night products.
  2. Other nighttime analgesics: combinations of NSAID plus sedating antihistamine can capture the same “pain + sleep” buyer.
  3. Non-ibuprofen pain relievers: acetaminophen-based nighttime products can displace ibuprofen if consumers perceive tolerability advantages or if price gaps widen.

Regulatory and safety constraints

Diphenhydramine introduces the primary compliance constraint common to antihistamine sleep OTC products:

  • dosing limits and label warnings tied to sedation and impairment risk
  • consumer advisories around older adults and contraindications

These constraints shape how brands message benefits and can affect conversion during periods of heightened consumer attention to sedation safety.

Supply chain and consumer health inventory

OTC performance is sensitive to:

  • manufacturer trade inventory cycles
  • retailer ordering patterns ahead of promotions
  • cost inflation passing through at shelf level

For brands with established distribution, inventory availability and promotional cadence often explain short-run volatility more than demand-side changes.

How does Advil PM fit into the broader ibuprofen and OTC analgesic market?

Market logic

Ibuprofen dominates a core OTC analgesic need state, while “PM/nighttime” branding monetizes a secondary need state. That structure tends to produce:

  • more stable baseline performance relative to single-purpose sleep aids (pain relief remains a larger and more frequent daily use need)
  • higher promotional reliance than plain ibuprofen because combination value is more easily substituted by either category

Pricing power

Pricing power typically erodes in three common conditions:

  • increased generic penetration in the NSAID base
  • retailer promotion cycles (drugstore and big-box repeating “value resets”)
  • competitive entry or increased marketing spend by rival “nighttime pain/sleep” SKUs

Brands sustain price by:

  • maintaining perceived “nighttime efficacy” through consistent dosing and formulation
  • protecting trade relationships through promotional planning
  • defending shelf position through brand investment

What is the financial trajectory signal for this product category and brand ecosystem?

How to interpret financial trajectory for OTC brands

For branded OTC products like Advil PM, financial trajectory is usually evidenced by:

  • consumer health segment revenue trends
  • brand-level share and net sales growth in the OTC analgesic set
  • margin impact from commodity and promotional intensity
  • retail execution and distribution metrics (share of shelf, velocity, and out-of-stock)

Advil is a long-standing brand within consumer health (branded ibuprofen). Advil PM’s trajectory generally follows:

  • the ibuprofen OTC demand cycle
  • the promotional intensity of the “nighttime” subcategory
  • shifts toward or away from antihistamine-based sleep relief products

Expected directionality

In mature OTC categories, the most common multi-year patterns are:

  • flat-to-low single-digit unit growth with share moves tied to promotions and retailer execution
  • revenue growth driven by price and pack mix rather than volume
  • margin variability as promotional depth changes and input costs shift

Implications for investors and R&D planners

  • If you underwrite performance using units, expect more cyclicality tied to retail promotional calendars.
  • If you underwrite using revenue, assume price and mix drive most of the observed trajectory in later-stage maturity.
  • If you underwrite using category substitution, treat “nighttime” as the key pivot: growth comes from winning the “pain + sleep” shopper, not from expanding pain incidence.

What are the key levers shaping near-term market performance?

Promotional calendar and retailer resets

Near-term sales often swing based on:

  • coupon depth and multi-pack deals
  • retailer price resets (especially during high-traffic periods)
  • media support intensity

For OTC combination brands, promotion can raise penetration but also can compress margin quickly.

Formulation and pack strategy

Product-level improvements that typically move performance include:

  • pack size and value packs aligned with household purchasing patterns
  • dosing convenience (how quickly the consumer can take the tablet before sleep)
  • consistent supply of popular SKUs

Competitive marketing

In OTC analgesics, competitors can shift performance by:

  • running price-led promotions for generic-equivalent alternatives
  • increasing “nighttime” messaging against sedating antihistamine products
  • emphasizing tolerability or fewer warnings (within regulatory boundaries)

Regulatory messaging and consumer sentiment

When consumer attention increases on:

  • sedation risks, driving impairment, and older adult guidance
  • antihistamine safety brands can see demand shifts even without product reformulations.

What does this mean for financial outcomes (revenue, share, and profitability)?

Revenue: generally price-and-mix led

For mature OTC brands:

  • revenue tends to grow through pricing and pack mix even when unit growth is modest
  • promotional frequency can create a “volume bump,” then normalize

A plausible read-through for Advil PM is that revenue trajectory tracks Advil’s broad OTC pain demand plus premium capture tied to “PM” differentiation.

Share: won through retail execution and “nighttime” differentiation

Share movement is typically:

  • retailer-shelf dependent
  • promotional-cycle dependent
  • sensitive to stock availability and planogram changes

Profitability: margin affected by promotions

Margins swing when:

  • competitors lead with deeper promotions
  • brands respond with increased trade spending
  • input costs rise and require catch-up pricing

For a combination product, profitability depends on whether the “PM” premium remains intact after retailer-led price pressure.

Key scenario map: where growth comes from and where it breaks

Growth vectors

  • Winning incremental nighttime pain/sleep users from single-agent pain products
  • Capturing retailer promotion-led unit gains without margin collapse
  • Maintaining distribution and avoiding out-of-stock events during winter peaks

Downside vectors

  • Generic-driven substitution in the NSAID base
  • Shifts away from antihistamine sleep aids due to safety messaging intensity
  • Competitive “nighttime” bundling with aggressive price positions

Key Takeaways

  • Advil PM demand is driven by “pain + sleep” intent at retail, not by prescription-class dynamics.
  • Market performance is most sensitive to promotional cadence, shelf execution, and substitution between OTC pain relief and OTC sleep aid categories.
  • The financial trajectory in mature OTC categories is typically price-and-mix led, with unit volatility tied to retailer calendars.
  • Profitability is exposed to promotional intensity because generics and competing nighttime combinations compress pricing premiums.

FAQs

  1. What drives Advil PM sales most strongly?
    Retail promotional activity, “nighttime pain + sleep” shopper conversion, and winter cold-season demand patterns.

  2. How does Advil PM compare to generic ibuprofen products?
    Generic ibuprofen compresses pricing on the NSAID portion, so Advil PM’s differentiation relies on the added sedating sleep benefit and nighttime branding.

  3. What categories most threaten Advil PM?
    OTC pain relievers (including acetaminophen-based nighttime products) and alternative sleep aids that capture the sedating component shopper.

  4. Is Advil PM’s growth volume or revenue driven?
    In mature OTC segments, revenue growth typically comes more from price and pack mix, while unit growth depends on promotions and shelf execution.

  5. What external factors can shift demand without product changes?
    Consumer sentiment and safety messaging on sedating antihistamines, retailer planogram changes, and promotional depth cycles.


References

[1] U.S. Food and Drug Administration (FDA). OTC drug facts labeling and antihistamine/sedating ingredient labeling guidance. FDA.
[2] FDA. Consumer information and warnings related to sedating antihistamines in OTC drug products. FDA.
[3] IQVIA. Retail scan and OTC category performance reporting (as cited in public market commentary). IQVIA.
[4] NielsenIQ. Consumer health OTC category market intelligence (as cited in public market commentary). NielsenIQ.

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