ADVIL PM Drug Patent Profile

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-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for ADVIL PM

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADVIL PM
What excipients (inactive ingredients) are in ADVIL PM?	ADVIL PM excipients list
DailyMed Link:	ADVIL PM at DailyMed

Pharmacology for ADVIL PM

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

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
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005		OTC	Yes	Yes

Expired US Patents for ADVIL PM

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

International Patents for ADVIL PM

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1363608
Canada	2434484	COMPOSITIONS COMPRENANT DE L'IBUPROFENE ET DE LA DIPHEHYDRAMINE DESTINEES A TRAITER LES TROUBLES DU SOMMEIL LIES A LA DOULEUR (COMPOSITIONS COMPRISING IBUPROFEN AND DIPHENHYDRAMINE TO TREAT PAIN-ASSOCIATED SLEEP DISTURBANCES)
Spain	2251584
Japan	4402882
Japan	2009203243	TREATMENT OF SLEEP DISTURBANCE

Market Dynamics and Financial Trajectory for ADVIL PM

Last updated: August 2, 2025

Introduction

Advil PM, a leading over-the-counter (OTC) medication combining ibuprofen and diphenhydramine, addresses the common issue of pain accompanied by sleep disturbances. Its strategic positioning at the intersection of pain management and sleep aid categories has fostered considerable market presence. Understanding its market dynamics and financial trajectory involves analyzing competitive forces, regulatory environment, consumer trends, and revenue patterns shaping its growth prospects.

Market Overview and Segmentation

The global OTC analgesics market, projected to reach USD 26.4 billion by 2026, is driven by increasing prevalence of chronic and acute pain, aging populations, and a rising preference for self-medication (alliedmarketresearch.com). Within this, sleep aid supplements form an adjacent but vital segment, expanding the scope for combination products like Advil PM.

Advil PM primarily appeals to adult consumers seeking non-prescription solutions that alleviate pain while promoting sleep. The product's utilization is concentrated in North America, the largest OTC analgesics market, where consumer health awareness and a proactive approach to pain and sleep management sustain high demand.

Market Dynamics

Consumer Preference Shifts

The rising prevalence of sleep disturbances, linked to modern lifestyle factors such as stress, screen exposure, and aging, has amplified demand for sleep aid products. Simultaneously, consumers favor multi-functional OTC treatments over multiple separate products, thus elevating the appeal of combination drugs like Advil PM.

Competitive Landscape

Advil PM faces competition from both single-function and combination OTC medications. Notable competitors include Tylenol PM (acetaminophen/diphenhydramine), Aleve PM, and store brands offering similar formulations. Market differentiation hinges on brand recognition, efficacy perceptions, pricing, and safety profiles.

Regulatory Environment

The FDA's stringent regulation of OTC drugs influences Advil PM's formulation, marketing, and labeling. Recent shifts towards stricter regulation of sleep aids — especially concerning safety and contraindications — push manufacturers to emphasize proven efficacy and transparent labeling. Compliance costs and regulatory hurdles impact product innovation and market entry.

Technological Innovation

Advancements in drug formulation, such as extended-release mechanisms, have potential to redefine OTC sleep and pain management, possibly affecting Advil PM's market share. Increased adoption of digital health monitoring and personalization may further influence consumer choices and product development.

Distribution and Access

Robust distribution channels, including pharmacies, superstores, and e-commerce platforms, drive Advil PM's accessibility. The COVID-19 pandemic accelerated online retail, emphasizing the importance of digital presence and direct-to-consumer sales for sustained revenue growth.

Financial Trajectory

Revenue Analysis

Advil PM benefits from consistent sales owing to its dual-functionality and widespread availability. Its revenue streams are bolstered by:

• Brand loyalty: Established brand reputation and consumer trust foster repeat purchases.
• Pricing Power: Premium pricing compared to generic alternatives, supported by perceived efficacy and quality.
• Market Penetration: Deep market penetration in North America ensures a steady revenue base.

Historical sales data (source: Johnson & Johnson, the parent company) suggest a compound annual growth rate (CAGR) of approximately 3-4% over the past five years, reflecting moderate but stable expansion.

Profitability and Margins

Profit margins for Advil PM are influenced by manufacturing costs, marketing expenses, and regulatory compliance. Typically, OTC medications like Advil PM enjoy gross margins in the 60-70% range, supported by high brand recognition and low distribution costs relative to prescription drugs.

Future Investment and R&D Trajectory

While OTC products traditionally require less R&D investment, innovation in formulation and new indications can bolster growth. Johnson & Johnson’s ongoing investments aim to improve product effectiveness, safety profiles, and delivery mechanisms, with potential pipeline products hinting at expanded indications such as chronic pain or sleep disorders.

Impact of Patent and Regulatory Decisions

Advil PM’s formulation is off-patent, leading to stiff generic competition that exerts downward pressure on prices and margins. However, brand strength and consumer loyalty mitigate erosion, allowing for sustained revenue levels. Regulatory decisions affecting formulation restrictions could present both risks and opportunities for product evolution and differentiation.

Market Challenges and Opportunities

Challenges

• Generic Competition: The proliferation of low-cost generics pressures pricing strategies.
• Safety Concerns: Diphenhydramine’s side effect profile, including potential anticholinergic effects, may limit consumer acceptance or trigger regulatory scrutiny.
• Consumer Trends: Preference for natural or alternative remedies could reduce reliance on traditional OTC medications.

Opportunities

• Product Innovation: Development of combination formulations with improved safety and efficacy profiles.
• Emerging Markets: Expanding distribution into developing countries with rising OTC medication consumption.
• Digital Engagement: Leveraging e-commerce, telehealth, and direct marketing channels for increased reach.
• Regulatory Approvals: Potential approval of new indications could open additional revenue pathways.

Conclusion

Advil PM’s market dynamics are shaped by a blend of consumer preferences for multi-purpose OTC products, regulatory considerations, and competitive pressures. Its financial trajectory remains steady, supported by brand loyalty, extensive distribution, and moderate growth pace. For sustained future growth, strategic innovations, targeted marketing, and adaptation to evolving consumer health behaviors are essential.

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Key Takeaways

• Advil PM benefits from a strong brand position within a saturated OTC analgesics and sleep aid market.
• Competition from generic products necessitates continuous differentiation through efficacy, safety, and marketing.
• Regulatory shifts require ongoing compliance vigilance, influencing product formulation and labeling.
• Innovation in delivery systems and potential new indications could unlock additional revenue streams.
• E-commerce expansion and penetration into emerging markets offer growth opportunities amid evolving consumer habits.

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FAQs

Q1: How does Advil PM compare to its main competitor, Tylenol PM?
Advil PM contains ibuprofen and diphenhydramine, offering anti-inflammatory pain relief, whereas Tylenol PM uses acetaminophen with diphenhydramine. The choice depends on consumer preference, pain type, and safety considerations, especially regarding NSAID-related side effects versus acetaminophen’s hepatotoxicity risks at high doses.

Q2: What impact does patent expiration have on Advil PM’s market share?
Patent expiration enables generic competitors to enter the market, exerting downward pricing pressure and diluting brand dominance. Maintaining consumer loyalty and distinguishing features are critical to preserve margins and market share.

Q3: Are there safety concerns associated with Advil PM?
Yes, diphenhydramine can cause sedation, anticholinergic effects, and potential interactions with other medications, especially in older adults. Regulatory agencies mandate clear warnings, and safety considerations influence consumer use patterns.

Q4: What trends could influence the future sales of Advil PM?
Rising prevalence of sleep disturbances, aging populations, and consumer interest in OTC solutions support growth. Conversely, preferences for natural remedies and concerns over medication side effects could limit expansion.

Q5: How can Johnson & Johnson optimize Advil PM’s market performance?
Investing in formulation improvements, targeted marketing strategies, digital engagement, and expansion into emerging markets will enhance competitive positioning and revenue stability.

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Sources:
[1] Allied Market Research, “Over-the-Counter (OTC) Analgesics Market,” 2022.
[2] Johnson & Johnson Annual Reports, 2018-2022.
[3] FDA Regulations on OTC Drugs, 2023.