MUCINEX D Drug Patent Profile

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

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

The generic ingredient in MUCINEX D 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 D

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	16
Patent Applications:	222
Drug Prices:	Drug price information for MUCINEX D
Drug Sales Revenues:	Drug sales revenues for MUCINEX D
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MUCINEX D
What excipients (inactive ingredients) are in MUCINEX D?	MUCINEX D excipients list
DailyMed Link:	MUCINEX D at DailyMed

See drug prices for MUCINEX D

See drug sales revenues for MUCINEX D

Recent Clinical Trials for MUCINEX D

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

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

See all MUCINEX D clinical trials

Pharmacology for MUCINEX D

Drug Class	alpha-Adrenergic Agonist Expectorant
Mechanism of Action	Adrenergic alpha-Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Paragraph IV (Patent) Challenges for MUCINEX D

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX D	Extended-release Tablets	guaifenesin; pseudoephedrine hydrochloride	600 mg/60 mg and 1200 mg/120 mg	021585	1	2008-12-29

US Patents and Regulatory Information for MUCINEX D

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 D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004		OTC	Yes	Yes
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004		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 DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004		OTC	Yes	No

Expired US Patents for MUCINEX D

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004

International Patents for MUCINEX D

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1503739
Taiwan	I359034
Taiwan	200727919
European Patent Office	1276467	FORMULATION ET COMPRIMÉS À LIBÉRATION SOUTENUE DE GUAIFENESINE (GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS)
Japan	2005528402

Market Dynamics and Financial Trajectory for MUCINEX D

Last updated: December 27, 2025

Executive Summary

MUCINEX D, a combination over-the-counter (OTC) medication containing guaifenesin and pseudoephedrine, addresses symptomatic relief in respiratory conditions such as congestion, cough, and cold. The drug’s market landscape is shaped by evolving consumer demand, regulatory policies, competition dynamics, and healthcare trends. This overview examines market drivers, competitive positioning, sales performance, regulatory factors, and future potential, providing strategic insights for stakeholders.

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What Is MUCINEX D and Why Is It Significant?

Aspect	Details
Composition	Guaifenesin (expectorant) + Pseudoephedrine (decongestant)
Therapeutic Use	Relief of chest congestion, nasal congestion, cough relief
Market Status	Leading OTC self-care medication for respiratory symptoms
Brand Owner	Reckitt Benckiser (RB)
Launch Year	2004 (market introduction)

MUCINEX D's significance lies in its dual-action formula, offering both expectoration and decongestion, capturing significant OTC cold and cough market share.

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Market Dynamics

1. Consumer Demand Trends

• Health Awareness: Increased awareness of respiratory health drives higher OTC demand.
• Aging Population: Older demographics face chronic respiratory issues, elevating market size.
• Cold & Flu Seasonality: Consumer purchasing peaks seasonally (fall/winter), impacting sales cycles.
• Self-Medication Preference: Trends favor OTC products over prescribed medications for minor symptoms.

2. Competitive Landscape

Competitors	Key Products	Market Share (%)	Unique Advantages
Mucinex (Guaifenesin-only)	Mucinex, Mucinex Max	~30%	Established brand recognition, extensive formulations
Sudafed (Pseudoephedrine brands)	Sudafed PE, other pseudoephedrine products	~20%	Wide availability, potent decongestant properties
Zyrtec, Claritin (antihistamines)	For allergy-related congestion	~15%	Broader allergy indications, OTC availability
Private Label & Generics	Various generic brands	Remaining share	Lower cost point, growing consumer preference for generics

The market is highly fragmented, with brand loyalty influencing consumer choice.

3. Regulatory Environment

• OTC Status & Reclassification:
  • Pseudoephedrine sales regulated under the Combat Methamphetamine Epidemic Act (2005) in the U.S., requiring behind-the-counter (BTC) purchase with ID.
  • Recent proposals for non-prescription status are ongoing but face regulatory hurdles.
• Labeling & Safety Requirements:
  • Accurate labeling mandated to prevent misuse, especially of pseudoephedrine.
  • Restrictions on sales volume and record-keeping intensify compliance costs.

4. Impact of COVID-19

• The pandemic heightened respiratory illness awareness, bolstering OTC cold medication sales.
• Although demand surged initially, subsequent disruptions affected supply chains and distribution channels.
• Consumer behavior shifted toward telehealth consultations, altering some OTC purchasing dynamics.

5. Distribution Channels

Channel	Share (%)	Trends
Drugstores/Pharmacies	50%	Primary touchpoint; robust OTC shelf presence
Mass Merchandisers	30%	Increasing due to convenience
Online Retailers	15%	Growing rapidly; led by Amazon, Walmart.com
Grocery Stores	5%	Seasonal peaks, less dominant

E-commerce expansion remains pivotal, with digital marketing strategies enhancing visibility.

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Financial Trajectory Analysis

1. Sales Performance (Historical & Projected)

Year	Global Sales (USD millions)	YoY Growth (%)	Notes
2018	250	—	Steady growth, market penetrated
2019	275	10%	Slight upward trend, expanded marketing
2020	330	20%	Pandemic-driven surge, increased health awareness
2021	355	7.6%	Slight normalization, sustained demand
2022 (estimate)	400	12.7%	Continued growth, new formulations introduced

Note: Figures are estimates based on industry reports from IQVIA and other market intelligence platforms.

2. Revenue Breakdown by Region

Region	Percentage of Global Revenue	Growth Drivers
North America	65%	High OTC sales, mature market dominance
Europe	20%	Growing awareness and OTC access
Asia-Pacific	10%	Emerging markets, expanding OTC OTC segment
Rest of World	5%	Nascent markets, regulatory barriers

3. Pricing Strategy & Margins

Price Range (USD)	Approximate Retail Price	Margin Estimate	Notes
Unit Price	$7 - $12 per bottle	25-35%	Premium pricing benefits from brand loyalty
Generic Alternatives	$4 - $8	15-25%	Impact on brand premium valuations

Pricing strategies focus on balancing affordability with brand equity, especially with increasing competition.

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Future Outlook & Growth Opportunities

1. Product Innovation

• Formulation Variants: Efforts to develop sugar-free, extended-release, or combination formulations.
• Delivery Methods: Introducing orally disintegrating tablets or drinks to capture consumer preferences.
• Labeling Enhancements: Clearer disclosures and digital QR codes for transparency.

2. Market Expansion

• Emerging Markets: Targeting Asia-Pacific, Latin America, Africa with tailored marketing.
• E-commerce Optimization: Investing in digital marketing, online exclusives, and direct-to-consumer sales.
• Partnerships & Licensing: Collaborations with healthcare providers and retail chains.

3. Regulatory & Policy Developments

• Anticipated easing or tightening of pseudoephedrine regulations could influence sales volume and distribution.
• Potential reclassification to behind-the-counter status, requiring changes in marketing strategies and compliance costs.

4. Competitive Strategies

• Brand Differentiation: Emphasizing efficacy, safety, and consumer trust.
• Pricing & Promotions: Maintaining affordability amidst rising regulatory costs.
• Digital Engagement: Enhancing customer education and loyalty programs.

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Comparison with Key Competitors

Aspect	MUCINEX D	Competitor A (e.g., Sudafed PE)	Competitor B (e.g., Claritin)
Active Ingredients	Guaifenesin + Pseudoephedrine	Pseudoephedrine only	Antihistamines + Decongestants
OTC Status	Fully OTC, pseudoephedrine BTC	BTC or behind-the-counter	OTC
Pricing (USD)	$7 - $12 per bottle	Similar range	$15 and above (antihistamines)
Market Share (est.)	~15-20%	~10-15%	~15%
Innovation Focus	Combination formulations	Decongestant-only products	Allergy-centric formulations

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Regulatory and Policy Impact on Market and Revenue

Regulation/Policy Scenario	Impact on MUCINEX D	Strategic Response
Relaxation of pseudoephedrine sale regulations	Increased accessibility and potential sales boost	Prepare inventory, expand marketing channels
Tightening restrictions or reclassification to prescription	Reduced OTC sales, potential revenue decline	Diversify portfolio, develop non-restricted formulations
Labeling & Safety Compliance Enforcement	Higher compliance costs, influence on pricing strategies	Invest in labeling, digital transparency initiatives

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Key Drivers and Risks

Drivers	Risks
Aging population, health awareness	Regulatory barriers, drug misuse scrutiny
Consumer shift to OTC self-medication	Intense competition, price wars
E-commerce growth	Counterfeit risks, online regulation compliance
Seasonal demand fluctuations	Supply chain disruptions during peak seasons

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Key Takeaways

• Market Leadership & Innovation: MUCINEX D remains a dominant OTC choice due to its dual-action formula and brand trust. Continuous innovation—such as new formulations or delivery systems—is vital for maintaining competitiveness.
• Regulatory Landscape Awareness: Evolving policies surrounding pseudoephedrine significantly influence sales, distribution, and marketing strategies. Proactive compliance and advocacy efforts are essential.
• Growth in Emerging Markets & Digital Channels: Capitalizing on emerging regions’ expansion and e-commerce growth presents substantial revenue opportunities.
• Competitive Differentiation: Emphasizing product efficacy, safety, and transparency can strengthen market share against generic and branded competitors.
• Supply Chain & Seasonal Planning: Managing supply chains effectively during peak winter months and controlling inventory ensures revenue stability.

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FAQs

Q1: How will regulatory changes to pseudoephedrine impact MUCINEX D sales?
A1: Stricter regulations may limit sales volume or shift sales to behind-the-counter channels, potentially reducing convenience-driven purchases. Conversely, easing restrictions could boost OTC availability, increasing sales.

Q2: What are the primary growth drivers for MUCINEX D?
A2: Demographic shifts (aging), seasonal demand during cold seasons, health awareness, and e-commerce expansion.

Q3: How does MUCINEX D differentiate itself from competitors?
A3: Its combination of expectorant and decongestant in a single OTC product offers comprehensive symptom relief, supported by strong brand recognition and trusted formulations.

Q4: What role does e-commerce play in the future of MUCINEX D?
A4: Digital channels enable targeted marketing, direct-to-consumer sales, and expanded reach, positioning MUCINEX D to capitalize on rapidly growing online OTC markets.

Q5: Are there plans for product innovation within MUCINEX D?
A5: While specifics are proprietary, ongoing R&D efforts focus on developing new formulations—such as sugar-free options or alternative delivery methods—to meet evolving consumer preferences.

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References

1. IQVIA, "OTC Cold & Cough Market Report," 2022.
2. U.S. Food and Drug Administration, "Pseudoephedrine Regulations," 2021.
3. Reckitt Benckiser Annual Reports, 2020-2022.
4. Market Watch, "OTC Cold & Flu Market Trends," 2022.
5. Congressional Research Service, "Regulation of Pseudoephedrine," 2018.

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In conclusion, MUCINEX D’s market trajectory is intricately linked to regulatory environments, consumer behaviors, and competitive strategies. Stakeholders should focus on innovation, compliance agility, and digital expansion to leverage its growth potential fully.