DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - Generic Drug Details

What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of patent protection?

Dextromethorphan hydrobromide; guaifenesin is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, Sun Pharm, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Sixty-three suppliers are listed for this compound.

Summary for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	63
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
DailyMed Link:	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN at DailyMed

Pharmacology for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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

Anatomical Therapeutic Chemical (ATC) Classes for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

R05CA	Expectorants
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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	021620-001	Apr 29, 2004		OTC	Yes	Yes
Amneal Pharms	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	209692-002	Nov 1, 2018		OTC	No	No
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004		OTC	Yes	No
Aurobindo Pharma	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	206941-001	Mar 17, 2017		OTC	No	No
Actavis Labs Fl	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	091070-001	Aug 31, 2015		OTC	No	No

Expired US Patents for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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	6,955,821
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004	6,372,252
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004	7,838,032
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004	6,372,252
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004	7,838,032

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Guaifenesin

Introduction

Dextromethorphan hydrobromide and guaifenesin are two widely used active ingredients in over-the-counter (OTC) medications, particularly for treating respiratory conditions such as coughs, colds, and bronchial congestion. This article delves into the market dynamics and financial trajectory of these drugs, highlighting key trends, drivers, and challenges.

Market Overview

The market for dextromethorphan hydrobromide and guaifenesin is part of the broader respiratory care market, which has seen significant growth due to increasing prevalence of respiratory conditions like chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections.

Dextromethorphan Market

• The dextromethorphan market is expected to grow at a CAGR of 4.1% over the forecast period, driven by its widespread use as a cough suppressant[1].
• The market is slightly fragmented, with notable companies such as AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical holding significant market shares.

Guaifenesin Market

• The global guaifenesin market is projected to grow at a CAGR of 7.4% from 2023 to 2033, reaching a value of approximately $2.7 billion by 2033[3].
• Guaifenesin, an expectorant, is in high demand due to its effectiveness in treating respiratory conditions by facilitating the clearance of mucus.

Key Drivers

Increasing Prevalence of Respiratory Conditions

• The growing prevalence of COPD, asthma, and acute respiratory infections globally drives the demand for both dextromethorphan and guaifenesin. For instance, COPD affected approximately 251 million individuals worldwide in 2022, and asthma prevalence in the U.S. remains significant, affecting about 25 million people[3].

COVID-19 Impact

• The COVID-19 pandemic has significantly impacted the market, leading to increased demand for cough and cold medications. Despite initial disruptions in production and supply chains, the recovery phase saw a surge in the production and demand for these medications[4].

Expanding Pharmaceutical Sector

• The pharmaceutical sector, particularly in emerging markets like India and Brazil, is experiencing rapid growth. This expansion, coupled with increasing healthcare awareness and rising incidences of respiratory ailments, presents significant growth opportunities for guaifenesin and dextromethorphan[3].

Market Segmentation

Product Type

• For guaifenesin, the market is segmented into tablets, granules, syrups, and others, with tablets leading the market share in 2023[3].
• Dextromethorphan is often combined with guaifenesin in extended-release tablets, which help in loosening phlegm and suppressing coughs[2].

Application

• Guaifenesin is primarily used as a mucolytic agent and cough suppressant, with the cough suppressant segment holding a significant share of the market[3].
• Dextromethorphan is used to temporarily relieve coughs due to minor throat and bronchial irritation, making it a crucial component in combination medications like Mucinex DM[5].

Distribution Channel

• The market is segmented into retail pharmacies, hospital pharmacies, and online pharmacies. Hospital pharmacies dominate the distribution channel, holding the largest revenue share in the guaifenesin market[3].

Regional Analysis

North America

• North America leads the guaifenesin market with the highest revenue share, driven by increased incidences of respiratory conditions and heightened awareness of respiratory health post-COVID-19[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 in countries like China and India[3].

Financial Trajectory

Revenue Projections

• The global guaifenesin market is expected to grow from $1.3 billion in 2023 to $2.7 billion by 2033, at a CAGR of 7.4%[3].
• The dextromethorphan market, while growing at a slightly lower CAGR of 4.1%, is still expected to see significant revenue growth driven by its widespread use in combination medications.

Investment Opportunities

• The expanding healthcare infrastructure and growing consumer base in emerging markets present lucrative investment opportunities for pharmaceutical companies. For instance, the Indian pharmaceutical sector is projected to grow at a CAGR of 10% during the forecast period, indicating robust market potential for OTC medications[3].

Challenges and Opportunities

Availability of Substitutes

• One of the major challenges facing the guaifenesin market is the availability of substitutes. However, the unique combination of guaifenesin with dextromethorphan in medications like Mucinex DM continues to drive demand due to its efficacy in treating respiratory symptoms[4].

Regulatory Approvals

• Regulatory approvals for new formulations and combinations of guaifenesin with other active ingredients have enhanced its market presence. This trend is expected to continue, offering growth opportunities for pharmaceutical companies[3].

Consumer Behavior and Preferences

• Consumers are increasingly seeking cost-effective, accessible remedies for respiratory conditions. The proliferation of e-commerce platforms has facilitated easier access to these medications, contributing to market expansion[3].

Side Effects and Safety Considerations

• While these medications are generally safe, side effects such as drowsiness associated with dextromethorphan can impact consumer behavior. Healthcare providers play a crucial role in advising patients on the safe use of these medications[5].

Key Takeaways

• The markets for dextromethorphan and guaifenesin are driven by the increasing prevalence of respiratory conditions and the COVID-19 pandemic.
• North America and the Asia Pacific region are key markets, with the latter expected to experience the highest CAGR.
• The global guaifenesin market is projected to reach $2.7 billion by 2033, growing at a CAGR of 7.4%.
• Combination medications like Mucinex DM, which include both dextromethorphan and guaifenesin, are in high demand due to their efficacy in treating respiratory symptoms.
• Regulatory approvals and expanding pharmaceutical infrastructure in emerging markets offer significant growth opportunities.

FAQs

Q: What are the primary uses of dextromethorphan and guaifenesin? A: Dextromethorphan is used as a cough suppressant, while guaifenesin is an expectorant that helps in loosening and thinning mucus to ease chest congestion[5].

Q: How has the COVID-19 pandemic impacted the market for these drugs? A: The pandemic has led to increased demand for cough and cold medications, despite initial disruptions in production and supply chains. The recovery phase saw a surge in production and demand[4].

Q: Which region is expected to experience the highest CAGR in the guaifenesin market? A: 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[3].

Q: What are the major challenges facing the guaifenesin market? A: The availability of substitutes and potential side effects are major challenges. However, the unique combination of guaifenesin with dextromethorphan continues to drive demand[4].

Q: How do regulatory approvals impact the market for these drugs? A: Regulatory approvals for new formulations and combinations of guaifenesin with other active ingredients have enhanced its market presence and are expected to continue offering growth opportunities[3].

Sources:

1. Mordor Intelligence, "Dextromethorphan - Market Share Analysis, Industry Trends ...", 2024.
2. DailyMed, "GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release", Updated December 18, 2023.
3. Market.us, "Global Guaifenesin Market Size, Share | CAGR Of 7.4%", 2024.
4. IndustryARC, "Guaifenesin Market Size Report, 2022-2027", 2024.
5. Cleveland Clinic, "Dextromethorphan Guaifenesin (Mucinex DM) oral solution", 2024.