MUCINEX Drug Patent Profile

When do Mucinex patents expire, and when can generic versions of Mucinex launch?

Mucinex is a drug marketed by Rb Hlth and is included in three NDAs.

The generic ingredient in MUCINEX is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for MUCINEX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	16
Patent Applications:	3,351
Drug Prices:	Drug price information for MUCINEX
Drug Sales Revenues:	Drug sales revenues for MUCINEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MUCINEX
What excipients (inactive ingredients) are in MUCINEX?	MUCINEX excipients list
DailyMed Link:	MUCINEX at DailyMed

See drug prices for MUCINEX

See drug sales revenues for MUCINEX

Recent Clinical Trials for MUCINEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vitaccess Ltd	Phase 4
American Health Research	Phase 4
Massachusetts Eye and Ear Infirmary	N/A

See all MUCINEX clinical trials

Pharmacology for MUCINEX

Drug Class	Expectorant
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Paragraph IV (Patent) Challenges for MUCINEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX	Extended-release Tablets	guaifenesin	600 mg and 1.2 gm	021282	1	2006-06-09

US Patents and Regulatory Information for MUCINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002		OTC	Yes	Yes
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004		OTC	Yes	No
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002		OTC	Yes	No

Expired US Patents for MUCINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002	6,372,252
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	7,838,032
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	6,372,252

International Patents for MUCINEX

See the table below for patents covering MUCINEX around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2405031	FORMULATION ET COMPRIMES DE LIBERATION SOUTENUE DE GUAIFENESINE (GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS)
Spain	2301537
New Zealand	521959	Guaifenesin sustained release formulation and tablets

Market Dynamics and Financial Trajectory for MUCINEX

Last updated: July 28, 2025

Introduction

MUCINEX, a leading over-the-counter (OTC) expectorant medication, has long been a staple in managing cough and cold symptoms, particularly for alleviating mucus congestion. Its active ingredient, guaifenesin, has garnered regulatory approval worldwide and enjoys broad consumer trust. As the pharmaceutical landscape evolves, understanding MUCINEX's market dynamics and financial trajectory offers critical insights for stakeholders seeking strategic positioning, investment opportunities, and competitive analysis.

Market Overview

The global expectorant market, with MUCINEX as a key player, demonstrates steady growth driven by increasing consumer awareness of respiratory health, aging populations, and the seasonal prevalence of cold and flu. The OTC drugs segment within respiratory therapeutics is estimated to expand at a compound annual growth rate (CAGR) of approximately 4–6% over the next five years, influenced by broader shifts toward self-medication and digital health platforms for product accessibility [1].

MUCINEX’s dominance in the expectorant space is reinforced by its longstanding consumer recognition, widespread retail availability, and broad formulation portfolio. The brand’s positioning aligns with health authorities’ recommendations for mucus clearance, further entrenching its appeal during peak cold and allergy seasons.

Market Drivers

1. Consumer Health Trends: Increased emphasis on self-care and home-based remedies spurs demand for effective, safe OTC expectorants like MUCINEX. The COVID-19 pandemic amplified focus on respiratory symptom management, although direct links to COVID-19 treatment remain limited. Nevertheless, heightened vigilance toward respiratory health may sustain elevated market interest.

2. Product Innovation and Line Extensions: Introduction of formulation variants—such as extended-release tablets, combination products with cough suppressants, and formulations targeting specific age groups—expand MUCINEX’s reach. Innovation helps differentiate the brand amid intense OTC competition.

3. Regulatory Environment: Regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) maintain consistent guidelines around expectorants. While regulatory approval processes are rigorous, the established safety profile of guaifenesin facilitates stable market access and minimizes regulatory risk.

4. Distribution Channels: Enhanced e-commerce platforms and widespread pharmacy networks drive accessibility. COVID-19 accelerated OTC sales via online channels, providing new revenue streams for MUCINEX.

Market Challenges

• Generic Competition: The presence of numerous generic guaifenesin products underscores price competition, constraining profit margins. Brand loyalty and consumer perception of efficacy serve as differentiators for MUCINEX but face erosion amid proliferation of generics.

• Regulatory Scrutiny: Potential future regulatory measures, such as restrictions on OTC ingredients or labeling requirements, could impact product formulary or market claims.

• Consumer Skepticism and Misinformation: Misinformation about expectorant efficacy can influence purchase decisions, necessitating robust marketing and educational efforts.

• Evolving Consumer Preferences: Increased interest in natural, herbal, and alternative remedies may shift demand away from synthetic expectorants, compelling MUCINEX to innovate or diversify.

Financial Trajectory

MUCINEX's revenue generation is primarily derived from OTC sales through retail chains, pharmacies, and online platforms. Global sales approximate hundreds of millions of dollars annually, with North America—the largest market segment—accounting for over 60% of revenue [2].

Historical Performance and Growth Patterns

Over the past decade, MUCINEX has experienced moderate but consistent growth. The brand's revenues have benefited from seasonal peaks during cold and flu seasons, with periods of stagnation or slight decline attributed to market saturation and increased generic competition. The COVID-19 pandemic temporarily disrupted traditional retail channels but also stimulated demand for respiratory symptom relief, including expectorants.

Strategic Initiatives and Future Outlook

• Product Diversification: Expanding formulations, particularly combination therapies, positions MUCINEX to cater to broader consumer needs, including cough suppression and allergy relief. The integration of natural ingredients or alternative delivery methods (e.g., liquids, lozenges) can catalyze growth.

• Digital and E-commerce Expansion: Partnerships with online retailers and telemedicine platforms enable direct-to-consumer sales, expanding reach, especially among younger demographics.

• Global Market Penetration: Emerging markets in Asia, Latin America, and Africa present substantial growth opportunities, driven by rising disposable incomes, increasing health awareness, and expanding OTC distribution channels.

• Regulatory Strategy: Proactive engagement with regulators to facilitate approval of new formulations or claims enhances market agility and protects against regulatory disruptions.

Financial Projections

Based on current market trends, it is reasonable to project MUCINEX's global sales will grow at a CAGR of approximately 3–5% over the next five years. The growth rate may accelerate with successful product innovations and expansion into emerging markets. Operating margins are anticipated to remain stable or slightly improve through cost optimization and strategic marketing.

The brand’s profitability will also depend on managing pricing strategies amid generic competition and navigating regulatory requirements effectively. Large pharmaceutical companies backing MUCINEX possess financial resilience, enabling sustained investment in R&D and marketing to support growth trajectories.

Competitive Landscape

MUCINEX faces pressure from both global OTC brands (e.g., Robitussin, Delsym) and private-label products. The competitive edge hinges on brand trust, formulation diversity, consumer engagement, and distribution strength. Strategic alliances with healthcare providers and digital marketing are increasingly integral to safeguarding market share.

Regulatory and Patent Considerations

While guaifenesin's patent protections have largely expired, formulation patents and proprietary delivery systems can serve as barriers against direct competition. Continuous monitoring of patent landscapes and regulatory updates is necessary to mitigate infringement risks and defend market position.

Impact of External Factors

Economic fluctuations influence consumer spending on OTC medicines; recessionary periods could dampen sales, whereas health crises may temporarily boost demand. Additionally, standardization and quality assurance are vital for maintaining consumer confidence and compliance with evolving regulations.

Conclusion

MUCINEX’s market dynamics reflect a mature but evolving OTC expectorant segment. Leveraging product innovation, expanding into new geographies, and embracing digital distribution channels will be pivotal to sustaining its financial trajectory. Despite challenges posed by generics and regulatory pressures, the brand's established reputation and strategic initiatives underpin its continued growth.

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Key Takeaways

• MUCINEX remains a dominant brand in the expectorant market, with consistent revenue streams rooted in consumer trust and broad distribution networks.

• Growth prospects hinge on product innovation, increased presence in emerging markets, and expansion through digital sales channels.

• Competitive pressures from generics necessitate strategic differentiation via formulation development and marketing.

• The expected CAGR of 3–5% over the next five years reflects moderate but stable growth, with potential for acceleration through targeted initiatives.

• Staying ahead of regulatory changes and monitoring patent landscapes are crucial for maintaining market leverage and profitability.

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FAQs

1. What is the primary active ingredient in MUCINEX, and how does it work?
The main active ingredient is guaifenesin, an expectorant that thins and loosens mucus in the airways, facilitating easier clearance during respiratory illnesses.

2. How has COVID-19 impacted MUCINEX sales?
The pandemic temporarily disrupted traditional retail channels but also increased consumer focus on respiratory health, leading to a spike in demand for related OTC products, including MUCINEX, especially via e-commerce.

3. What are key strategies for MUCINEX to maintain market dominance?
Product innovation, expanding formulations, leveraging digital platforms, entering emerging markets, and proactive regulatory engagement are essential strategies.

4. How does generic competition affect MUCINEX’s profitability?
Generics exert pricing pressure, squeezing margins. MUCINEX mitigates this through brand loyalty, formulation patents, and marketing campaigns emphasizing efficacy and safety.

5. What growth opportunities exist outside North America?
Emerging markets in Asia, Latin America, and Africa offer significant potential due to increasing healthcare awareness, rising disposable incomes, and expanding OTC distribution networks.

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Sources
[1] MarketsandMarkets. "Respiratory Therapeutics Market by Product, Application, and Region." 2022.
[2] IMS Health (IQVIA). "Global OTC Market Data." 2022.