MUCINEX DM Drug Patent Profile

Which patents cover Mucinex Dm, and when can generic versions of Mucinex Dm launch?

Mucinex Dm is a drug marketed by Rb Hlth and is included in one NDA.

The generic ingredient in MUCINEX DM 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 DM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	16
Drug Prices:	Drug price information for MUCINEX DM
Drug Sales Revenues:	Drug sales revenues for MUCINEX DM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MUCINEX DM
What excipients (inactive ingredients) are in MUCINEX DM?	MUCINEX DM excipients list
DailyMed Link:	MUCINEX DM at DailyMed

See drug prices for MUCINEX DM

See drug sales revenues for MUCINEX DM

Recent Clinical Trials for MUCINEX DM

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 DM clinical trials

Pharmacology for MUCINEX DM

Drug Class	Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Paragraph IV (Patent) Challenges for MUCINEX DM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX DM	Extended-release Tablets	dextromethorphan hydrobromide; guaifenesin	600 mg/30 mg and 1200 mg/60 mg	021620	1	2008-12-17

US Patents and Regulatory Information for MUCINEX DM

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 DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004		OTC	Yes	No
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004		OTC	Yes	Yes

Expired US Patents for MUCINEX DM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004

International Patents for MUCINEX DM

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

Country	Patent Number	Title	Estimated Expiration
Germany	60133538
Denmark	1276467
Hong Kong	1052651
Taiwan	I326602

Supplementary Protection Certificates for MUCINEX DM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166	CR 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	122013000090	Germany		PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166	92323	Luxembourg		PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624

Market Dynamics and Financial Trajectory for MUCINEX DM

Last updated: July 29, 2025

Introduction

Mucinex DM, a widely used over-the-counter (OTC) expectorant and cough suppressant, has carved a significant niche within the respiratory medication market. Combining guaifenesin, an expectorant, with dextromethorphan, a cough suppressant, Mucinex DM addresses a common respiratory ailment—coughs associated with colds and bronchitis. Understanding the market dynamics and financial trajectory of Mucinex DM involves dissecting its competitive landscape, regulatory environment, consumer preferences, and sales performance.

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Market Overview and Industry Context

The global OTC respiratory drugs market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2028, driven by increasing prevalence of respiratory illnesses, aging populations, and a growing preference for self-medication among consumers [1]. Mucinex DM, positioned within this burgeoning segment, benefits from high brand recognition, extensive distribution networks, and consumer trust derived from its parent company, Reckitt Benckiser.

The demand for combination remedies such as Mucinex DM continues to rise, fueled by consumers’ desire for simplified treatment regimens. Additionally, OTC products like Mucinex DM are favored for their accessibility, avoiding the barriers associated with prescription medications, thus contributing significantly to the revenue streams of pharmaceutical companies.

Regulatory Landscape and Impact

The regulatory environment remains relatively stable for OTC medications like Mucinex DM, with the U.S. Food and Drug Administration (FDA) overseeing safety standards. However, changes regarding ingredient safety, labeling, and advertising practices influence market access and sales. Notably, dextromethorphan’s potential for misuse has prompted scrutiny, leading companies to implement responsible marketing and monitor adverse events. Regulatory shifts can impact formulations, marketing strategies, and ultimately, financial performance.

Furthermore, patent expirations and the proliferation of generic versions pose competitive challenges, exerting downward pressure on prices and margins. Reckitt Benckiser’s strategic response involves ongoing innovation, extension of product lines, and maintaining brand dominance.

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Competitive Landscape

Mucinex DM operates in a highly competitive environment involving other OTC brands such as Robitussin DM (Pfizer), Delsym, and Equate Dextromethorphan products. The competitive dynamics are characterized by:

• Brand Loyalty: Mucinex benefits from strong consumer loyalty, rooted in its efficacy reputation, taste, and packaging.
• Pricing Strategies: Price promotions, bundling, and competitive pricing influence consumer choice.
• Product Differentiation: Variants with extended-release formulations or added ingredients (e.g., vitamin C) enhance market appeal.
• Distribution Channels: Widespread availability via pharmacies, supermarkets, e-commerce platforms, and direct-to-consumer marketing bolster sales.

The landscape is further shaped by rising interest in natural and herbal alternatives, compelling traditional pharmaceutical brands to innovate.

Consumer Trends and Behavioral Drivers

Consumer preferences skew towards products that promise fast, reliable relief with minimal side effects. The COVID-19 pandemic amplified demand for OTC cough and cold medications, including Mucinex DM, as consumers sought accessible relief without healthcare visits. Additionally, increasing health literacy and digital engagement influence purchasing decisions, shaping marketing strategies.

Financial Performance and Sales Trajectory

Reckitt Benckiser reports consistent sales growth for Mucinex, with the brand holding a significant market share within the cold and cough segment in North America. In the fiscal year 2022, Mucinex branded products generated over £500 million globally, underscoring its revenue-generating capacity [2].

Key factors influencing financial trajectory include:

• Market Penetration: Mucinex’s strong presence in retail outlets and online channels sustains sales momentum.
• Product Innovation: Launches of new formulations, such as Mucinex Sinus Max and Mucinex Fast-Max, diversify revenue streams.
• Pricing Power: Premium branding and product differentiation allow for favorable pricing strategies.
• Pandemic Impact: Elevated demand during COVID-19 contributed to short-term sales spikes, with normalization expected as the pandemic subsides.

Forecasts suggest steady growth, expected to mirror overall OTC respiratory market trends. Reckitt’s strategic investments in marketing and distribution are poised to support further expansion.

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Market Challenges and Risks

Despite positive outlooks, several challenges threaten to impede Mucinex DM’s financial trajectory:

• Regulatory Risks: Increased scrutiny over dextromethorphan’s misuse potential could induce stricter regulations or formulation restrictions.
• Generic Competition: The expiration of patents and proliferation of generic equivalents threaten profitability margins.
• Consumer Shift Towards Natural Remedies: Growing consumer interest in herbal and natural products may divert demand.
• Supply Chain Disruptions: Global supply chain issues could impact production costs and availability.

Strategic Implications

To sustain growth and optimize financial performance, Reckitt Benckiser adopts several strategic measures:

• Expanding product variants tailored to consumer needs.
• Enhancing digital marketing and e-commerce presence.
• Investing in formulations with improved safety profiles.
• Leveraging data analytics to refine targeting and consumer engagement.

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Key Takeaways

• The OTC respiratory segment, driven by increasing respiratory illness prevalence and consumer preference for self-medication, presents lucrative opportunities for Mucinex DM.
• Brand loyalty, strategic pricing, and distribution are catalysts that support Mucinex DM’s financial stability.
• Regulatory developments and patent expirations pose risks; proactive innovation and responsible marketing are essential.
• COVID-19 temporarily boosted sales, but sustained growth depends on maintaining relevance amid evolving consumer preferences.
• Continuous investment in product innovation, marketing, and supply chain resilience are critical to capitalizing on market opportunities.

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FAQs

1. How does regulatory scrutiny affect Mucinex DM’s market position?
   Stringent regulations, especially concerning dextromethorphan’s misuse potential, could restrict sales or lead to formulation adjustments, impacting market share and profitability.

2. What is the impact of generic competition on Mucinex DM’s revenue?
   Patent expirations enable generic manufacturers to produce similar formulations at lower prices, putting pressure on Mucinex’s margins and incentivizing brand differentiation.

3. How has COVID-19 influenced Mucinex DM sales?
   The pandemic heightened demand for OTC cough and cold remedies, resulting in short-term sales surges; ongoing growth depends on consumer health trends and product relevance.

4. What strategic initiatives are Reckitt Benckiser implementing for Mucinex DM?
   Focus areas include product innovation, expanding digital marketing, increasing availability across sales channels, and extending the product portfolio to cover broader respiratory issues.

5. What future market developments could influence Mucinex DM’s financial trajectory?
   Regulatory reforms, shifts in consumer preferences towards natural remedies, advancements in formulations enhancing safety, and supply chain factors will shape future performance.

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References

[1] Research and Markets. “Global OTC Respiratory Drugs Market Forecasts 2023-2028.” 2022.

[2] Reckitt Benckiser Group plc. Annual Report 2022.