Guaifenesin - Generic Drug Details

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

Guaifenesin is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Chartwell Rx, Sovereign Pharms, Eci Pharms Llc, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty-one NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for guaifenesin. Eighty-five suppliers are listed for this compound.

Summary for guaifenesin

US Patents:	3
Tradenames:	8
Applicants:	16
NDAs:	21
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	85
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	31
Patent Applications:	6,317
Drug Prices:	Drug price trends for guaifenesin
Drug Sales Revenues:	Drug sales revenues for guaifenesin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for guaifenesin
What excipients (inactive ingredients) are in guaifenesin?	guaifenesin excipients list
DailyMed Link:	guaifenesin at DailyMed

See drug prices for guaifenesin

See drug sales revenues for guaifenesin

Recent Clinical Trials for guaifenesin

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

Sponsor	Phase
Johnson & Johnson Consumer and Personal Products Worldwide	Phase 1
Hoffmann-La Roche
Massachusetts Eye and Ear Infirmary	N/A

See all guaifenesin clinical trials

Pharmacology for guaifenesin

Drug Class	Expectorant
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Medical Subject Heading (MeSH) Categories for guaifenesin

Expectorants

Anatomical Therapeutic Chemical (ATC) Classes for guaifenesin

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

Paragraph IV (Patent) Challenges for GUAIFENESIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX	Extended-release Tablets	guaifenesin	600 mg and 1.2 gm	021282	1	2006-06-09

US Patents and Regulatory Information for guaifenesin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
L Perrigo Co	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214407-002	Feb 1, 2022		OTC	No	No
Marksans Pharma	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	217780-002	Aug 21, 2023		OTC	No	No
Dr Reddys	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208369-001	Dec 29, 2017		OTC	No	No
Aurobindo Pharma Ltd	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213203-001	Mar 25, 2020		OTC	No	No
Guardian Drug	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	209215-001	Sep 6, 2017		OTC	No	No

Expired US Patents for guaifenesin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002	6,372,252
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	7,838,032
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	6,955,821
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	6,372,252
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002	6,955,821

Guaifenesin Market Analysis and Financial Projection Experimental

Global Guaifenesin Market Dynamics and Financial Trajectory

Market Overview

The global guaifenesin market is poised for significant growth, driven by increasing demand for effective expectorants to treat various respiratory conditions. Here’s a detailed look at the market dynamics and financial trajectory of guaifenesin.

Market Size and Growth

The global guaifenesin market is expected to expand substantially over the next decade. By 2033, the market is projected to reach approximately US$ 2.7 billion, up from US$ 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].

Drivers of Growth

Several factors are driving the growth of the guaifenesin market:

Prevalence of Respiratory Conditions

The increasing prevalence of respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections is a major driver. For instance, COPD affected approximately 251 million individuals globally in 2022, and asthma prevalence in the U.S. remains significant, affecting about 25 million people[1].

COVID-19 Impact

The COVID-19 pandemic has heightened awareness of respiratory health, leading to a surge in demand for over-the-counter expectorants like guaifenesin. The pandemic disrupted supply chains but also led to increased production and demand for cough and cold medications in the recovery phase[4].

Regulatory Approvals

Recent regulatory approvals for new formulations and combinations of guaifenesin with other active ingredients have enhanced its market presence. For example, Marksans Pharma received FDA approval for guaifenesin extended-release tablets in 2023[3].

Product Type and Application Segments

The market is segmented by product type and application:

Product Type

The product type segment includes tablets, granules, syrups, and others. In 2023, tablets led the market with a share of 42.7%[1].

Application

The application segment includes mucolytic agents, cough suppressants, and others. Cough suppressants held a significant share of 48.3% in 2023[1].

Distribution Channels

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%[1].

Regional Analysis

North America

North America leads the market with a revenue share of 39.7% in 2023, driven by increased incidences of respiratory conditions and heightened awareness of respiratory health post-COVID-19. The region's pharmaceutical sector has seen significant growth, with companies expanding product lines and increasing production capacities[1].

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. Rapid urbanization and increasing pollution levels in countries like China and India have led to a higher incidence of respiratory issues[1].

Competitive Landscape

Key players in the guaifenesin market include Perrigo Company plc, Lupin, Johnson & Johnson, Hikma Pharmaceuticals PLC, Eli Lilly and Company, Bayer AG, AstraZeneca plc, Marksans Pharma Ltd., and others. These companies are actively launching and promoting expectorant drugs, contributing to market expansion[1][3].

Financial Trajectory

Revenue Forecast

The global guaifenesin market generated a revenue of US$ 1.3 billion in 2023 and is expected to reach US$ 2.7 billion by 2033, growing at a CAGR of 7.4%[1].

Investment and R&D

The market is supported by rising R&D expenditure and investments in pharmaceutical infrastructure. For example, the Indian pharmaceutical sector is expected to reach USD 65 billion by 2024 and approximately USD 120-130 billion by 2030, indicating robust infrastructure capable of supporting increased production and distribution of medications like guaifenesin[1].

Challenges and Restraints

Despite the growth prospects, the guaifenesin market faces challenges such as the availability of substitutes and potential side effects. However, the benefits of guaifenesin, including its effectiveness as a mucolytic agent and its affordability, continue to drive its adoption[4].

Key Takeaways

• The global guaifenesin market is expected to reach US$ 2.7 billion by 2033, growing at a CAGR of 7.4%.
• North America leads the market, but the Asia Pacific region is expected to grow at the highest CAGR.
• The market is driven by the increasing prevalence of respiratory conditions and regulatory approvals for new formulations.
• Hospital pharmacies are the dominant distribution channel.
• Key players are actively launching and promoting expectorant drugs.

FAQs

What is the projected market size of the global guaifenesin market by 2033?

The global guaifenesin market is expected to reach approximately US$ 2.7 billion by 2033[1].

What is the CAGR of 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[1].

Which region dominates the guaifenesin market?

North America dominates the guaifenesin market with a revenue share of 39.7% in 2023[1].

What are the main drivers of the guaifenesin market?

The main drivers include the increasing prevalence of respiratory conditions, COVID-19 impact, and regulatory approvals for new formulations[1][3][4].

Who are the key players in the guaifenesin market?

Key players include Perrigo Company plc, Lupin, Johnson & Johnson, Hikma Pharmaceuticals PLC, and others[1][3].

Cited Sources

1. Market.us: Global Guaifenesin Market Size, Share | CAGR Of 7.4% - Report Overview.
2. MarketResearchIntellect: Guaifenesin API Powder Market Size, Scope And Forecast Report.
3. Mordor Intelligence: Expectorant Drugs Market Size & Share Analysis.
4. IndustryARC: Guaifenesin Market Size Report, 2022-2027.
5. OpenPR: Global Guaifenesin (API) Market: What Is The Projected Market.