Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details

What are the generic sources for guaifenesin; pseudoephedrine hydrochloride and what is the scope of patent protection?

Guaifenesin; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, Sun Pharm Inds Inc, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-one suppliers are listed for this compound.

Summary for guaifenesin; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	31
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for guaifenesin; pseudoephedrine hydrochloride
DailyMed Link:	guaifenesin; pseudoephedrine hydrochloride at DailyMed

Recent Clinical Trials for guaifenesin; pseudoephedrine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1
Reckitt Benckiser LLC	Phase 4
Reckitt Benckiser Inc.	Phase 4

See all guaifenesin; pseudoephedrine hydrochloride clinical trials

Pharmacology for guaifenesin; pseudoephedrine hydrochloride

Drug Class	Expectorant alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Anatomical Therapeutic Chemical (ATC) Classes for guaifenesin; pseudoephedrine hydrochloride

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

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 guaifenesin; pseudoephedrine hydrochloride

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	021585-001	Jun 22, 2004		OTC	Yes	No
Aurobindo Pharma Ltd	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213203-001	Mar 25, 2020		OTC	No	No
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004		OTC	Yes	Yes

Expired US Patents for guaifenesin; pseudoephedrine hydrochloride

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	6,955,821
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004	6,372,252
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	7,838,032

Guaifenesin; pseudoephedrine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Guaifenesin and Pseudoephedrine Hydrochloride

Introduction to Guaifenesin and Pseudoephedrine Hydrochloride

Guaifenesin and pseudoephedrine hydrochloride are commonly used in combination to treat respiratory symptoms such as cough, nasal congestion, and sinus pressure. Guaifenesin acts as an expectorant, thinning mucus to make it easier to cough up, while pseudoephedrine hydrochloride is a decongestant that reduces nasal congestion by narrowing blood vessels and decreasing blood flow to the nasal passages[4][5].

Market Size and Growth

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

Key Drivers of Market 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[1].

COVID-19 Impact

The COVID-19 pandemic has accelerated the demand for over-the-counter (OTC) medications, including those containing guaifenesin and pseudoephedrine hydrochloride. The pandemic led to increased awareness of respiratory health and a surge in the consumption of cough and cold remedies, contributing to market growth[3].

Expansion into Emerging Markets

Emerging economies, particularly in the Asia Pacific region, present significant growth opportunities. Countries like India and Brazil are experiencing rising incidences of respiratory ailments, driven by factors such as urbanization and increasing pollution levels. This has led to a higher demand for expectorants like guaifenesin[1].

Product Types and Applications

Product Types

The guaifenesin market is segmented into various product types, including tablets, granules, syrups, and others. In 2023, tablets held the largest market share of 42.7% due to their convenience and ease of administration[1].

Applications

Guaifenesin is used in several applications, including as a mucolytic agent, cough suppressant, and in combination with other medications. The cough suppressant segment held a significant share of 48.3% in 2023, reflecting the widespread use of guaifenesin in treating cough-related symptoms[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% in the guaifenesin market. This is due to the high demand for guaifenesin-based medications in hospital settings for treating various respiratory conditions[1].

Regional Analysis

North America's Leading Role

North America leads the guaifenesin market with a revenue share of 39.7% in 2023. The region's high incidence of respiratory conditions, coupled with increased healthcare awareness and the proliferation of e-commerce platforms, has driven the demand for OTC expectorants like guaifenesin[1].

Asia Pacific's Growth Potential

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. India's pharmaceutical sector, for instance, is projected to reach USD 120-130 billion by 2030, indicating robust growth potential for guaifenesin-based medications[1].

Challenges and Opportunities

Availability of Substitutes and Side Effects

The global guaifenesin market faces challenges such as the availability of substitute medications and potential side effects associated with guaifenesin. However, the development of new formulations and combinations of guaifenesin with other active ingredients is expected to mitigate these challenges and enhance market presence[3].

Regulatory Approvals and Innovations

Regulatory approvals for new guaifenesin formulations and the integration of advanced drug technologies are key opportunities for market growth. Pharmaceutical companies are expanding their product lines and increasing production capacities to meet the growing demand, further driven by the ease of access through e-commerce platforms[1].

Financial Trajectory

Revenue Projections

The global guaifenesin market is expected to grow from $1.3 billion in 2023 to $2.7 billion by 2033, with a CAGR of 7.4%. This growth is driven by increasing demand, expansion into emerging markets, and the development of new pharmaceutical technologies[1].

Investment and Production

Pharmaceutical companies are investing heavily in expanding their production capacities and developing new formulations to capitalize on the growing demand. The Indian pharmaceutical sector, for example, is expected to grow at a CAGR of 10% during the forecast period, indicating a robust market for OTC medications like guaifenesin[1].

Key Takeaways

• Market Growth: The global guaifenesin market is projected to reach $2.7 billion by 2033, growing at a CAGR of 7.4% from 2023.
• Product Types: Tablets dominate the market with a 42.7% share in 2023.
• Applications: Cough suppressant applications hold a significant share of 48.3%.
• Distribution Channels: Hospital pharmacies lead with a 46.5% revenue share.
• Regional Analysis: North America leads the market, while the Asia Pacific region is expected to grow at the highest CAGR.
• Challenges and Opportunities: Despite challenges from substitutes and side effects, regulatory approvals and innovations drive market growth.

FAQs

What is the primary use of guaifenesin in medical treatments?

Guaifenesin is primarily used as an expectorant to help loosen and thin mucus, making it easier to cough up and relieve respiratory symptoms such as cough and chest congestion[4][5].

How does the COVID-19 pandemic impact the guaifenesin market?

The COVID-19 pandemic has increased the demand for OTC medications, including those containing guaifenesin, due to heightened awareness of respiratory health and a surge in the consumption of cough and cold remedies[3].

Which region is expected to experience the highest CAGR in the guaifenesin market?

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[1].

What are the main distribution channels for guaifenesin-based medications?

The main distribution channels include retail pharmacies, hospital pharmacies, and online pharmacies, with hospital pharmacies holding the largest revenue share of 46.5%[1].

What are the potential challenges facing the guaifenesin market?

The market faces challenges such as the availability of substitute medications and potential side effects associated with guaifenesin. However, new formulations and regulatory approvals are expected to mitigate these challenges[3].

Sources

1. Market.us: Global Guaifenesin Market Size, Share | CAGR Of 7.4%[1]
2. Mayo Clinic: Hydrocodone, pseudoephedrine, and guaifenesin (oral route)[2]
3. IndustryARC: Guaifenesin Market Size Report, 2022-2027[3]
4. DailyMed: Guaifenesin and pseudoephedrine hydrochloride tablet, extended release[4]
5. DailyMed: Guaifenesin and pseudoephedrine hydrochloride tablet, extended release[5]