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-three 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:	2
Clinical Trials:	16
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
Vitaccess Ltd	Phase 4
American Health Research	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	021585-001	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
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

International Patents for MUCINEX D

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1108166
Mexico	PA04010225	LIBERACION SOSTENIDA DE LA COMBINACION DE GUAIFENESINA CON FARMACOS. (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS.)
Taiwan	I314866
European Patent Office	1913937
Hong Kong	1052651
Taiwan	I326602
Israel	164438

Market Dynamics and Financial Trajectory for Mucinex D

Introduction

Mucinex D, a widely recognized over-the-counter (OTC) medication, is used to alleviate symptoms of the common cold, hay fever, and upper respiratory allergies. It combines guaifenesin, an expectorant, and pseudoephedrine, a decongestant. Here, we delve into the market dynamics and financial trajectory of Mucinex D.

Market Size and Growth

The global guaifenesin market, which includes Mucinex D, is projected to experience significant growth. By 2033, the market is expected to reach approximately $2.7 billion, growing at a Compound Annual Growth Rate (CAGR) of 7.4% from $1.3 billion in 2023[3].

Product Variants and Availability

Mucinex D is available in two strengths: Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg, and Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg. These variants are sold in different package sizes, such as 18-count, 24-count, and 36-count packages, catering to various consumer needs[1][5].

Sales Performance

The Mucinex D brand and its store-brand equivalents have shown robust sales performance. As of May 2019, combined U.S. sales for Mucinex D and its store-brand equivalents were approximately $71 million for the preceding twelve months[1][5].

Market Drivers

Several factors drive the demand for Mucinex D:

Increasing Prevalence of Respiratory Conditions

The growing prevalence of respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections significantly boosts the demand for guaifenesin-based products. For instance, COPD affected approximately 251 million individuals globally in 2022, and asthma affects about 25 million people in the United States, including 5.5 million children[3].

COVID-19 Impact

The COVID-19 pandemic has heightened awareness of respiratory health, leading to an increased demand for over-the-counter expectorants like Mucinex D. This surge in demand is partly due to the pandemic's impact on respiratory health and the need for effective symptomatic treatments[3][4].

Expanding Distribution Channels

The proliferation of e-commerce platforms and the expansion of retail and hospital pharmacies have made Mucinex D more accessible to consumers. This increased accessibility has contributed to the market's growth[3].

Regional Market Analysis

North America

North America dominates the guaifenesin market, including Mucinex D, with a revenue share of 39.7% in 2023. The region's high incidence of respiratory conditions, coupled with increased healthcare awareness and robust pharmaceutical infrastructure, drives this market segment[3].

Asia Pacific

The Asia Pacific region is expected to experience the highest CAGR during the forecast period due to the rising prevalence of respiratory ailments and expanding pharmaceutical manufacturing capabilities. Countries like India and China, with rapid urbanization and increasing pollution levels, are seeing a higher incidence of respiratory issues, thus boosting demand for expectorants like Mucinex D[3].

Competitive Landscape

The market for Mucinex D is competitive, with several pharmaceutical companies involved in the production and distribution of guaifenesin-based products. Dr. Reddy’s Laboratories, for example, launched a store-brand equivalent of Mucinex D, which has contributed to the market's growth and competition[1][5].

Regulatory Environment

Regulatory approvals play a crucial role in the market dynamics of Mucinex D. For instance, Dr. Reddy’s OTC Guaifenesin and Pseudoephedrine HCl was approved by the U.S. Food and Drug Administration (USFDA), enabling its launch in the U.S. market[1][5].

Financial Projections

Given the growing demand and expanding market, the financial trajectory for Mucinex D is positive. Here are some key financial projections:

• Revenue Growth: The global guaifenesin market, which includes Mucinex D, is expected to grow from $1.3 billion in 2023 to $2.7 billion by 2033, at a CAGR of 7.4%[3].
• Market Share: North America currently holds the largest market share, but the Asia Pacific region is expected to grow at the fastest CAGR during the forecast period[3].

Key Takeaways

• The global guaifenesin market, including Mucinex D, is projected to reach $2.7 billion by 2033.
• The market is driven by increasing prevalence of respiratory conditions and the COVID-19 pandemic's impact on respiratory health.
• North America dominates the market, but the Asia Pacific region is expected to experience the highest growth rate.
• Regulatory approvals and expanding distribution channels are crucial for market growth.

FAQs

What are the key ingredients in Mucinex D?

Mucinex D contains guaifenesin, an expectorant, and pseudoephedrine, a decongestant[1][5].

How has the COVID-19 pandemic affected the demand for Mucinex D?

The COVID-19 pandemic has increased demand for Mucinex D due to heightened awareness of respiratory health and the need for effective symptomatic treatments[3][4].

Which region dominates the guaifenesin market, including Mucinex D?

North America currently dominates the guaifenesin market with a revenue share of 39.7% in 2023[3].

What is the expected CAGR for the global guaifenesin market from 2024 to 2033?

The global guaifenesin market is expected to grow at a CAGR of 7.4% from 2024 to 2033[3].

Who are some of the key players in the market for Mucinex D?

Key players include Dr. Reddy’s Laboratories, which launched a store-brand equivalent of Mucinex D, and other pharmaceutical companies involved in the production and distribution of guaifenesin-based products[1][5].

Sources

1. Dr. Reddy’s Announces the Launch of the Over-the-counter Store Brand Equivalent of Mucinex® D Extended Release Tablets in Two Strengths in the U.S. Market. Business Wire.
2. Mucinex maker reports 161% increase in sales. Gale.
3. Global Guaifenesin Market Size, Share | CAGR Of 7.4%. Market.us.
4. Guaifenesin Market Size, Trends | Industry Report 2021 - 2030. Allied Market Research.
5. Dr. Reddy's Announces the Launch of the Over-the-counter Store Brand Equivalent of Mucinex® D Extended Release Tablets in Two Strengths in the U.S. Market. BioSpace.