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-three 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:	122
Clinical Trials:	16
Patent Applications:	3,082
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
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004		OTC	Yes	Yes

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	021282-001	Jul 12, 2002	6,955,821
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
Denmark	1276467
Germany	60133538
Taiwan	I314866
European Patent Office	1276467	FORMULATION ET COMPRIMÉS À LIBÉRATION SOUTENUE DE GUAIFENESINE (GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS)

MUCINEX Market Analysis and Financial Projection Experimental

Global Guaifenesin (Mucinex) Market Dynamics and Financial Trajectory

Market Overview

The global guaifenesin market, commonly associated with the brand name Mucinex, is experiencing significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this essential expectorant.

Market Size and Growth

The global guaifenesin market is projected to grow substantially over the next decade. By 2033, the market is expected to reach approximately US$ 2.7 billion, up from US$ 1.3 billion in 2023, with a Compound Annual Growth Rate (CAGR) of 7.4% during the forecast period from 2024 to 2033[1].

Drivers of Growth

Increasing Prevalence of Respiratory Conditions

The rising incidence of respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections is a major driver of the guaifenesin market. According to the World Health Organization, COPD affected approximately 251 million individuals globally in 2022, highlighting the need for effective symptomatic treatments like guaifenesin[1].

COVID-19 Impact

The COVID-19 pandemic has had a significant impact on the market. While the initial phase saw disruptions in production and supply chains, the recovery phase led to a surge in demand for cough and cold medications, including those containing guaifenesin. This surge is expected to continue as healthcare infrastructure and drug production recover and expand[4].

Pharmaceutical Sector Development

Advancements in the pharmaceutical sector, including innovative drug technologies and the development of new formulations, are also driving market growth. The Indian pharmaceutical sector, for example, is expected to reach USD 65 billion by 2024 and approximately USD 120-130 billion by 2030, indicating robust infrastructure capable of supporting increased production and distribution of medications like guaifenesin[1][4].

Product Types and Applications

Product Types

The guaifenesin market is segmented by product type into tablets, granules, syrups, and others. In 2023, tablets led the market with a share of 42.7%. The versatility of these product forms, especially the convenience of tablets and the ease of administration of syrups, contributes to their popularity[1].

Applications

Guaifenesin is primarily used as a mucolytic agent and cough suppressant. The cough suppressant segment held a significant share of 48.3% in 2023. The drug's effectiveness in thinning mucus and facilitating its clearance makes it a crucial component in cough treatment medications[1].

Distribution Channels

Dominance of Hospital Pharmacies

The distribution channel segment is divided into retail pharmacies, hospital pharmacies, and online pharmacies. Hospital pharmacies dominate the market, holding the largest revenue share of 46.5%. This is due to the high demand for guaifenesin in hospital settings for treating various respiratory conditions[1].

Regional Analysis

North America

North America leads the guaifenesin market with a market share of 39.7% in 2023. The region's high incidence of respiratory conditions, heightened awareness of respiratory health post-COVID-19, and the proliferation of e-commerce platforms have contributed to this dominance. Regulatory approvals for new formulations have also enhanced the market presence of guaifenesin in this region[1].

Asia Pacific

The Asia Pacific region is expected to experience the highest CAGR during the forecast period. Rapid urbanization, increasing pollution levels, and expanding pharmaceutical manufacturing capabilities in countries like China and India are driving the demand for expectorants like guaifenesin[1].

Financial Performance of Key Players

Reckitt

Reckitt, the company behind Mucinex, has seen mixed results in recent years. While their OTC portfolio, including Mucinex, experienced a low-single digit decline in the first half of 2024 due to a softer end to the cold and flu season and retailer inventory destocking, the company remains optimistic about revenue growth in the second half of the year. Reckitt reported a group net revenue growth of 0.8% on a like-for-like basis, with health segment growth partially offset by declines in seasonal OTC brands[2].

Revenue and Profit Margins

Despite challenges, Reckitt's health segment delivered strong growth in non-seasonal OTC brands and intimate wellness products. The company's adjusted operating profit margin was 23.5%, though this was offset by increased brand equity investment and fixed costs. Free cash flow was £821 million, an 8% increase year on year, reflecting strong cash flow generation and confidence in future growth[2].

Challenges and Opportunities

Availability of Substitutes and Side Effects

The guaifenesin market faces challenges from the availability of substitute products and potential side effects. However, the drug's efficacy and widespread use continue to drive demand, especially in regions with high prevalence of respiratory conditions[4].

Regulatory Approvals and Innovations

Regulatory approvals for new formulations and combinations of guaifenesin with other active ingredients are expected to enhance its market presence. Innovations in drug technologies and the development of extended-release tablets and other forms are also likely to boost market growth[1][4].

Key Takeaways

• The global guaifenesin market is projected to reach US$ 2.7 billion by 2033, growing at a CAGR of 7.4%.
• North America dominates the market, driven by high incidences of respiratory conditions and increased awareness post-COVID-19.
• The Asia Pacific region is expected to experience the highest CAGR due to rising prevalence of respiratory ailments and expanding pharmaceutical manufacturing.
• Hospital pharmacies are the dominant distribution channel, holding 46.5% of the market share.
• Regulatory approvals and innovations in drug technologies are key drivers of market growth.

FAQs

What is the expected market size of guaifenesin by 2033?

The global guaifenesin market is expected to reach approximately US$ 2.7 billion by 2033[1].

What is the primary driver of the guaifenesin market?

The primary driver is the increasing prevalence of respiratory conditions such as COPD, asthma, and acute respiratory infections[1].

Which region dominates the guaifenesin market?

North America dominates the market with a market share of 39.7% in 2023[1].

What are the main product types of guaifenesin?

The main product types are tablets, granules, syrups, and others, with tablets leading the market in 2023[1].

How has the COVID-19 pandemic impacted the guaifenesin market?

The pandemic initially disrupted production and supply chains but later led to a surge in demand for cough and cold medications, including those containing guaifenesin[4].

Sources

1. Market.us: Global Guaifenesin Market Size, Share | CAGR Of 7.4% - https://market.us/report/global-guaifenesin-market/
2. Reckitt: RECKITT ANNOUNCES H1 RESULTS AND STRATEGIC UPDATE - https://www.reckitt.com/media/5lkjj12r/reckitt-rns-fy24-h1-results.pdf
3. ACCP: Pharmacokinetic Studies in Healthy Subjects for the Development of Guaifenesin - https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.8
4. IndustryARC: Guaifenesin Market Size Report, 2022-2027 - https://www.industryarc.com/Research/Global-Guaifenesin-Market-Research-511494
5. Reckitt: Reckitt Full Year 2023 Results - https://www.reckitt.com/media/hovlwv3a/transcript-reckitt-full-year-2023-results.pdf