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-three 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:	5
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
Vitaccess Ltd	Phase 4
American Health Research	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	021620-002	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
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	021620-002	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
China	1655766
European Patent Office	1276467	FORMULATION ET COMPRIMÉS À LIBÉRATION SOUTENUE DE GUAIFENESINE (GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS)
Canada	2481739	LIBERATION REGULIERE DE MEDICAMENTS COMBINES DE GUAIFENESIN (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS)
Hong Kong	1052651
Spain	2301537
European Patent Office	1503739
Taiwan	200733952

Supplementary Protection Certificates for MUCINEX DM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
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	SPC/GB13/070	United Kingdom		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626
1539166	2013/055	Ireland		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION 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

MUCINEX DM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mucinex DM

Introduction

Mucinex DM, a combination of guaifenesin and dextromethorphan, is a widely used over-the-counter (OTC) medication for relieving cough and chest congestion. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The expectorant drugs market, which includes Mucinex DM, is projected to grow steadily. As of 2024, the expectorant drugs market is estimated to be around USD 100 million and is expected to reach USD 120 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period[3].

Key Drivers

Several factors drive the demand for Mucinex DM and similar expectorant drugs:

Prevalence of Respiratory Diseases

The high prevalence of respiratory diseases such as the common cold, influenza, and pneumonia in regions like North America significantly contributes to the demand for these medications. For instance, in 2022, 4.6% of adults in the U.S. reported being diagnosed with Chronic Obstructive Pulmonary Disease (COPD), emphysema, or chronic bronchitis, according to the Centers for Disease Control and Prevention (CDC)[3].

Consumer Preferences and Habits

Changes in food consumption habits among youth and middle-class consumers have led to an increase in cough cases worldwide, driving the demand for guaifenesin-based products like Mucinex DM[4].

Regulatory Environment

Strict regulations against the use of codeine in many countries have boosted the demand for non-opioid expectorants like guaifenesin. This regulatory landscape has created opportunities for researchers to formulate non-opioid expectorants, further driving the market growth[4].

Financial Performance

Historical Sales

Mucinex DM Maximum Strength has shown significant financial performance. Retail sales of Mucinex DM Maximum Strength totaled about $128 million over a 12-month period prior to 2018, highlighting its market success[1].

Launch of Generic Versions

The approval and launch of generic versions, such as Perrigo’s store-brand equivalent of Mucinex DM Maximum Strength, have provided consumers with high-quality, value alternatives. This move has been an important accomplishment for Perrigo’s OTC business, indicating a strong financial trajectory for such products[1].

Market Competition

Major Players

The market for expectorant drugs is moderately concentrated, with key players like Reckitt Benckiser and Perrigo Co. playing significant roles. The entry of generic versions by companies like Perrigo has increased competition, offering consumers more choices and potentially impacting the market share of branded products[3].

Geographic Market

Dominant Regions

North America is the largest market for expectorant drugs due to the high prevalence of respiratory diseases and the presence of key players. The Asia Pacific region is expected to be the fastest-growing market, driven by increasing demand from developing countries[3].

Product Features and Benefits

Mechanism of Action

Mucinex DM combines guaifenesin, an expectorant that thins and loosens mucus, and dextromethorphan, a cough suppressant. This combination helps control coughing and makes coughs more productive by breaking up chest congestion[5].

Extended-Release Formulation

The extended-release formulation of Mucinex DM provides both immediate and extended relief, lasting up to 12 hours. Each dose contains 1200 mg of guaifenesin and 60 mg of dextromethorphan hydrobromide, ensuring sustained relief from cough and congestion[5].

Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic has significantly impacted the demand for cough and cold medications, including Mucinex DM. The increased cases of respiratory infections during the pandemic have surged the demand for these drugs, presenting opportunities for manufacturers[4].

"Increase in COVID-19 cases and availability of guaifenesin as OTC product in cough can significantly affect the market," highlighting the pandemic's influence on market dynamics[4].

Future Outlook

The expectorant drugs market, including Mucinex DM, is poised for growth driven by increasing respiratory disease prevalence, regulatory support for non-opioid alternatives, and rising demand from developing countries. However, the market may face challenges from stringent regulations and the availability of substitutes.

Key Takeaways

• The expectorant drugs market is growing at a CAGR of 4.5% from 2024 to 2029.
• Mucinex DM has significant market sales, with retail sales totaling $128 million over a 12-month period.
• The launch of generic versions by companies like Perrigo has increased competition and provided value alternatives.
• North America is the largest market, with the Asia Pacific region expected to be the fastest-growing.
• The COVID-19 pandemic has increased demand for cough and cold medications.

FAQs

What are the key ingredients in Mucinex DM?

Mucinex DM contains guaifenesin, an expectorant, and dextromethorphan, a cough suppressant.

How long does the extended-release formulation of Mucinex DM last?

The extended-release formulation of Mucinex DM provides relief lasting up to 12 hours.

What is the estimated market size of the expectorant drugs market in 2024?

The expectorant drugs market is estimated to be around USD 100 million in 2024.

Which region is expected to be the fastest-growing market for expectorant drugs?

The Asia Pacific region is expected to be the fastest-growing market for expectorant drugs.

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

The COVID-19 pandemic has significantly increased the demand for cough and cold medications, including Mucinex DM, due to the rise in respiratory infections.

Sources

1. Chain Drug Review: Perrigo readies store-brand Mucinex DM Maximum Strength.
2. Gale: Mucinex maker reports 161% increase in sales.
3. Mordor Intelligence: Expectorant Drugs Market Size & Share Analysis.
4. Allied Market Research: Guaifenesin Market Size, Trends | Industry Report 2021 - 2030.
5. BevMo: Mucinex DM 12-Hour Max Strength Extended Release Tablets 7ct.