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Last Updated: December 25, 2024

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug 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.

Recent Clinical Trials for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1
Reckitt Benckiser LLCPhase 4
Reckitt Benckiser Inc.Phase 4

See all GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
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
Sun Pharm Inds Inc GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212542-001 Apr 28, 2020 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212542-002 Apr 28, 2020 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
L Perrigo Co GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214407-002 Feb 1, 2022 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 208369-002 Dec 29, 2017 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe ⤷  Subscribe
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 ⤷  Subscribe ⤷  Subscribe
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 ⤷  Subscribe ⤷  Subscribe
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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]

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