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.

Twenty-nine suppliers are listed for this compound.

Summary for guaifenesin; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	4
Patent Applications:	242
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
Dr Reddys	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208369-001	Dec 29, 2017		OTC	No	No
Actavis Labs Fl	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091071-002	May 27, 2015		OTC	No	No
L Perrigo Co	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214407-002	Feb 1, 2022		OTC	No	No
Aurobindo Pharma Ltd	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213203-002	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
Sun Pharm Inds Inc	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212542-001	Apr 28, 2020		OTC	No	No

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

Market Dynamics and Financial Trajectory for Guaifenesin and Pseudoephedrine Hydrochloride

Last updated: July 27, 2025

Introduction

Guaifenesin and pseudoephedrine hydrochloride are pivotal components in respiratory pharmacotherapy, predominantly used in over-the-counter (OTC) and prescription medications to treat cough, cold, and allergy symptoms. Their combined application underscores a substantial segment within the global respiratory drugs market, exhibiting unique market dynamics influenced by evolving regulatory landscapes, consumer preferences, manufacturing trends, and technological advancements. This analysis elucidates the current market trends, regulatory considerations, and financial prospects surrounding these active pharmaceutical ingredients (APIs).

Market Overview

Guaifenesin: An Expectorant's Market Trajectory

Guaifenesin serves primarily as an expectorant, facilitating mucus clearance from the respiratory tract. Its ease of formulation and established efficacy sustain its steady demand in OTC formulations globally. According to IQVIA, the global expectorants market, with guaifenesin as a leading compound, generated approximately USD 1.3 billion in revenue in 2022, with a compound annual growth rate (CAGR) forecasted at around 4% through 2027 [1].

Pseudoephedrine Hydrochloride: A Decongestant's Evolving Landscape

Pseudoephedrine hydrochloride functions as a sympathomimetic decongestant, effectively reducing nasal congestion. However, its market trajectory faces complexities due to regulatory restrictions designed to prevent illicit methamphetamine manufacturing, leading to fluctuating market dynamics across different regions. The global decongestants market was valued at USD 3.2 billion in 2022, with pseudoephedrine constituting roughly 60% of this segment; projections indicate a modest CAGR of approximately 3% until 2027 [2].

Regulatory and Legal Considerations

Regulatory Frameworks Impacting Market Dynamics

Pseudoephredine's notoriety as a precursor for methamphetamine synthesis prompted regulatory controls, notably the US Combat Methamphetamine Epidemic Act (2005), mandating sales in behind-the-counter settings, requiring ID verification, and limited purchase quantities [3]. Similar regulations exist across the EU and Asian markets, influencing supply chains and R&D.

Guaifenesin, classified generally as OTC safe, encounters fewer restrictions; however, purity standards and quality regulations influence manufacturing costs and market entry barriers globally.

Impact on Supply Chain and Market Access

Stringent pseudoephedrine regulations have prompted pharmaceutical firms to pivot toward alternative formulations or synthetic substitutes, impacting market size and revenue streams. For guaifenesin, regulatory adherence remains straightforward, enabling consistent supply and pricing stability.

Manufacturing Trends and Technological Innovations

Manufacturing and Supply Chain Dynamics

The pharmaceutical industry's shift toward API synthesis optimization has improved cost-efficiency. Notably, advancements in green chemistry for pseudoephedrine synthesis aim to mitigate regulatory risks and reduce environmental impact.

Innovations in Drug Formulations

Combination products containing guaifenesin and pseudoephedrine are prevalent, offering symptomatic relief in a single dose, thus driving sustained demand. Novel formulations, such as sustained-release tablets and digital adherence tools, are enhancing treatment efficacy and patient compliance.

Competitive Landscape and Market Players

Major manufacturers include Johnson & Johnson, Perrigo, GSK, and local generic API producers. The duopoly of branded and generic drugs influences pricing strategies. Patent expirations for certain formulations foster generic entry, intensifying price competition.

Financial Trajectory Analysis

Revenue and Market Growth Prospects

The combined market for guaifenesin and pseudoephedrine-based products exhibits resilient growth amid a growing global respiratory disease burden. The OTC segment is projected to account for approximately 70% of the revenue, driven by consumer preferences for self-care.

Impact of Regulatory Changes on Revenues

Regulatory tightening, especially for pseudoephedrine, constrains sales volume, prompting shifts toward alternative decongestants such as phenylephrine. Market adaptation to these changes is essential for revenue stability.

Shifts Toward Differentiated and Value-Added Products

Product innovation incorporating natural extracts, enhanced formulations for rapid onset, and digital health integrations appeal to consumer trends, influencing future market valuations positively.

Future Outlook

The landscape suggests moderate yet steady growth, contingent upon regulatory reforms, technological upgrades, and consumer preferences. Increasing global health awareness and telemedicine adoption amplify demand, while supply chain resilience remains critical amid geopolitical tensions and pandemic disruptions.

Key Drivers and Barriers

Drivers	Barriers
Rising prevalence of respiratory ailments globally	Stringent regulations, especially for pseudoephedrine
Consumer preference for OTC medications	Regulatory compliance costs
Innovation in combination formulations	Supply chain disruptions
Growing awareness of self-medication	Potential shifts to alternative active ingredients

Key Takeaways

• Market resilience: Guaifenesin’s OTC status ensures steady demand, with incremental growth driven by product innovation and expanding healthcare awareness.
• Regulatory influence: Pseudoephedrine faces significant regulatory hurdles, influencing manufacturing practices and shifting focus to alternative decongestants.
• Strategic implications: Companies investing in regulatory compliance, manufacturing efficiency, and innovative formulations are better positioned for sustained growth.
• Global dynamics: Market expansion in emerging economies presents opportunities, but regulatory and supply chain challenges necessitate strategic agility.
• Future growth sectors: Digital health integration, personalized medicine approaches, and natural ingredient formulations shape the next phase of market development.

FAQs

1. How do regulatory restrictions on pseudoephedrine impact market supply?
Regulations limit sales quantities and require dual verification, reducing the availability of pseudoephedrine for OTC markets and prompting manufacturers to develop alternative decongestants or synthetic pathways.

2. Are there ongoing innovations in guaifenesin formulations?
Yes. Innovations include sustained-release tablets, combination products with other active ingredients, and formulations that enhance bioavailability and patient compliance.

3. What is the outlook for generic manufacturers of pseudoephedrine?
Regulatory constraints increase entry barriers; however, generic manufacturers capable of navigating compliance can benefit from stable demand and price competition.

4. How might emerging economies influence demand for these APIs?
Growing healthcare infrastructure and increasing respiratory disease prevalence elevate demand, offering expansion opportunities for manufacturers of both APIs.

5. Will natural or alternative compounds replace pseudoephedrine in the future?
Potentially, as consumer preferences shift toward natural remedies, and regulatory pressures favor safer alternatives; ongoing R&D may introduce new compounds with comparable efficacy.

References

[1] IQVIA. Global Respiratory Drugs Market Report, 2022.
[2] Market Data Forecast. Decongestants Market Size & Growth Analysis, 2022–2027.
[3] US Drug Enforcement Administration (DEA). Combat Methamphetamine Epidemic Act, 2005.