ADVIL COLD AND SINUS Drug Patent Profile

Which patents cover Advil Cold And Sinus, and what generic alternatives are available?

Advil Cold And Sinus is a drug marketed by Haleon Us Holdings and is included in two NDAs.

The generic ingredient in ADVIL COLD AND SINUS is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Advil Cold And Sinus

A generic version of ADVIL COLD AND SINUS was approved as ibuprofen; pseudoephedrine hydrochloride by STRIDES PHARMA on August 14^th, 2006.

Summary for ADVIL COLD AND SINUS

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
What excipients (inactive ingredients) are in ADVIL COLD AND SINUS?	ADVIL COLD AND SINUS excipients list
DailyMed Link:	ADVIL COLD AND SINUS at DailyMed

Pharmacology for ADVIL COLD AND SINUS

Drug Class	Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors

US Patents and Regulatory Information for ADVIL COLD AND SINUS

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 COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002		OTC	Yes	Yes
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019771-001	Sep 19, 1989		OTC	Yes	Yes

Expired US Patents for ADVIL COLD AND SINUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019771-001	Sep 19, 1989
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002

International Patents for ADVIL COLD AND SINUS

See the table below for patents covering ADVIL COLD AND SINUS around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8502485
Japan	S61501913
Japan	H08157355	AMPHOTERIC PHARMACEUTICAL SOLUTION FOR SOFT GEL FILLING, TWO-PIECE CAPSULE SEALING OR TABLET MANUFACTURING
South Korea	940008030
Japan	H07116021
Germany	3585495

Market Dynamics and Financial Trajectory for Advil Cold and Sinus

Last updated: July 30, 2025

Introduction

Advil Cold and Sinus, a prominent over-the-counter (OTC) cold and allergy relief medication, positions itself within the highly competitive OTC pharmaceutical segment. Combining ibuprofen with a nasal decongestant, typically pseudoephedrine or phenylephrine, it targets consumers seeking rapid symptom relief from cold, sinus pressure, headache, and nasal congestion. This analysis explores market dynamics influencing Advil Cold and Sinus's trajectory and projects the financial outlook within current industry trends.

Market Overview

The OTC cold and flu medications sector, valued at approximately $10 billion globally in 2022, persists as a resilient commercial domain. It benefits from a broad consumer base with acute and seasonal demand fluctuations, particularly during winter months and pandemic-related health concerns [1].

Advil Cold and Sinus competes primarily with brands like Tylenol Cold & Sinus, Aleve Cold & Sinus, and store brands offered by retail chains. Its main competitive advantages include brand recognition, perceived efficacy, and Walgreens’ and Pfizer’s distribution channels.

Market Drivers

Healthcare Consumer Trends

Increased consumer preference for self-medication—driven by convenience and cost-effectiveness—bolsters OTC medication demand [2]. Additionally, rising awareness about managing minor ailments at home reduces reliance on healthcare provider prescriptions, expanding OTC market penetration.

Aging Population and Disease Patterns

An aging demographic in developed markets enhances demand for symptomatic relief products. Senior consumers seek fast-acting solutions for chronic sinus issues and headache relief, directly benefiting Advil’s lineup.

Pandemic Impact

COVID-19 heightened consumer vigilance regarding respiratory health, causing a surge in cold and flu medication sales in 2020–2021. Although normalization has resumed, elevated health consciousness sustains demand [3].

Regulatory Environment

OTC medications face stable regulatory oversight by agencies like the FDA, ensuring safety and efficacy standards. However, restrictions on pseudoephedrine purchases impact the supply chain and sales; some jurisdictions impose purchase limits to prevent misuse [4].

Market Challenges

Competitive Pressure

Brand loyalty and aggressive marketing campaigns from competitors introduce pricing pressures. Store store brands and generics offer cheaper alternatives, eroding market share.

Regulatory and Safety Concerns

Regulatory scrutiny around decongestants' cardiovascular safety impacts formulation decisions, possibly limiting growth or prompting reformulations.

Supply Chain Disruptions

Global logistics issues, notably during COVID-19, affected raw material availability and distribution networks, leading to potential inventory constraints.

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Financial Trajectory Analysis

Historical Performance

Pfizer’s OTC segment, including Advil Cold and Sinus, reported consistent revenue contributions, with a slight decline in 2022 due to increased competition and supply chain disruptions. Nevertheless, brand strength sustains a steady customer base.

Projected Revenue Growth

Analysts project a compound annual growth rate (CAGR) of approximately 3–4% for Advil Cold and Sinus over the next five years, driven by:

• Product Innovation: Introduction of reformulated products incorporating novel delivery mechanisms or natural ingredients.
• Expansion into Emerging Markets: Growth potential exists in Asia-Pacific and Latin America, where OTC healthcare markets are expanding rapidly.
• Digital Marketing and E-commerce: Increasing online sales through direct-to-consumer channels.

Profitability Outlook

Gross margins are expected to stabilize around 60–65%, considering price pressures from generics and cost of raw materials. Net margins may remain modest, 15–20%, with operational efficiencies and marketing optimizations playing key roles.

Risks and Mitigation

Risks include regulatory tightenings, competition from generics, and adverse public health policies restricting pseudoephedrine sales. Strategic response involves diversifying formulations, investing in R&D for new deliverables, and expanding direct consumer engagement.

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Industry Trends Influencing Financials

Shift to Natural and Organic Alternatives

Growing consumer interest in "clean label" OTC products prompts innovation, which could impact sales if competitors introduce more appealing natural solutions.

Digital Transformation

E-commerce growth accelerates OTC sales via online retail and telehealth platforms, contributing to diversified revenue streams.

Regulatory Developments

Potential restrictions on nasal decongestants to prevent misuse could influence product formulations and reduce market size temporarily.

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Future Outlook

Advil Cold and Sinus’s market share is expected to maintain stability through continuous product innovation, responsive marketing, and geographic expansion. Its financial trajectory hinges upon successfully navigating regulatory requirements and competitive pressures — with opportunities for increased profitability through cost management and targeted marketing initiatives.

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Key Takeaways

• The OTC cold and sinus relief market remains resilient, with steady growth projected at 3–4% CAGR over the next five years, buoyed by consumer demand and market expansion.
• Advil Cold and Sinus benefits from strong brand recognition, despite competitive pressures from generics and store brands.
• Regulatory constraints on pseudoephedrine could influence sales volumes; diversification and product innovation are critical strategies.
• Digital channels and emerging markets represent significant growth avenues, supporting revenue diversification.
• Cost efficiencies and targeted marketing are essential to maintaining healthy margins amid price competition.

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FAQs

Q1: How does Advil Cold and Sinus differentiate itself in a crowded OTC market?
A: Leveraging Pfizer’s branding, proven efficacy, and targeted marketing campaigns, Advil Cold and Sinus emphasizes rapid symptom relief and trusted formulations to maintain consumer loyalty despite competition.

Q2: What impact will regulatory restrictions on pseudoephedrine have on Advil Cold and Sinus?
A: Restrictions may reduce sales volume or require reformulation. Pfizer might explore alternative decongestants or develop new formulations to sustain market presence.

Q3: How significant are emerging markets for Advil Cold and Sinus’s growth prospects?
A: They are vital; rapidly expanding OTC healthcare sectors in Asia-Pacific and Latin America offer substantial growth opportunities, especially as brand awareness increases.

Q4: What role does e-commerce play in Advil Cold and Sinus's future sales?
A: E-commerce channels provide direct access to consumers, enabling targeted marketing, larger reach, and potential sales growth, especially among younger demographics.

Q5: What are the primary risks to Advil Cold and Sinus’s financial trajectory?
A: Risks include regulatory changes, increased competition from generics, supply chain disruptions, and shifting consumer preferences toward natural remedies.

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Sources:
[1] MarketResearch.com, OTC Cold and Flu Medications Industry Report, 2022.
[2] IBISWorld, OTC Medicine Market Analysis, 2022.
[3] Statista, Consumer Behavior During COVID-19, 2022.
[4] FDA, Regulations on Pseudoephedrine Sales, 2021.