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Last Updated: December 22, 2024

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Guaifenesin And Pseudoephedrine Hydrochloride, and what generic alternatives are available?

Guaifenesin And Pseudoephedrine Hydrochloride is a drug marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, and Sun Pharm Inds Inc. and is included in six NDAs.

The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Guaifenesin And Pseudoephedrine Hydrochloride

A generic version of GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE was approved as guaifenesin; pseudoephedrine hydrochloride by ACTAVIS LABS FL on May 27th, 2015.

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Summary for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents:0
Applicants:6
NDAs:6
Finished Product Suppliers / Packagers: 28
Clinical Trials: 4
What excipients (inactive ingredients) are in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE?GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE excipients list
DailyMed Link:GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

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

See all GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-001 May 27, 2015 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Granules GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 216082-002 Aug 22, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213203-001 Mar 25, 2020 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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
Granules GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 216082-001 Aug 22, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-002 May 27, 2015 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

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Guaifenesin and Pseudoephedrine Hydrochloride

Market Overview

Guaifenesin and pseudoephedrine hydrochloride, commonly found in medications like Mucinex D, are key components in the treatment of respiratory conditions such as cough, nasal congestion, and chest congestion. Here’s a detailed look at the market dynamics and financial trajectory of this combination.

Global Market Size and Growth

The global guaifenesin market, which includes guaifenesin and pseudoephedrine hydrochloride combinations, is projected to experience significant growth. By 2027, the global guaifenesin market is forecasted to reach approximately USD 95 million, growing at a CAGR of around 3.1% from 2022 to 2027[1].

However, a more expansive forecast suggests that the global guaifenesin market will be worth around USD 2.7 billion by 2033, growing at a CAGR of 7.4% from 2023 to 2033. This growth is driven by the increasing prevalence of respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections[3].

Regional Market Performance

North America is the fastest-growing region in the global guaifenesin market. This region is expected to grow with a CAGR of around 4.5% during the forecast period, driven by developing medical infrastructure, growing cases of respiratory and cough-related complications, and rising health expenditure. The region accounted for the largest pharmaceutical sales, with 49% of global sales in 2020[1].

Product Type and Application

The market for guaifenesin and pseudoephedrine hydrochloride is segmented by product type, including tablets, granules, syrups, and others. Tablets lead the market, holding a 42.7% market share in 2023. In terms of application, the cough suppressant segment holds a significant share of 48.3%[3].

Distribution Channels

Hospital pharmacies dominate the distribution channel segment, holding the largest revenue share of 46.5% in the guaifenesin market. Retail pharmacies and online pharmacies also play significant roles, but hospital pharmacies remain the primary channel due to the high demand for these medications in clinical settings[3].

Drivers of Market Growth

Increasing Prevalence of Respiratory Conditions

The rise in cases of COPD, asthma, and acute respiratory infections drives the demand for guaifenesin-based medications. For instance, COPD affected approximately 251 million individuals globally in 2022, highlighting the need for effective symptomatic treatments[3].

Advancements in Pharmaceutical Sector

Innovative drug technologies and advancements in the pharmaceutical sector contribute to the growing demand for guaifenesin. The Indian hospital sector, for example, is expected to rise significantly, driving the demand for pharmaceutical medications[1].

Combination Therapies

Guaifenesin and pseudoephedrine hydrochloride combinations are widely used to relieve cough and nasal congestion. These combination therapies enhance the efficacy of treatment, making them a preferred choice for healthcare providers[2][4].

Challenges and Limitations

Availability of Substitutes

The global guaifenesin market faces challenges from the availability of substitute medications. This competition can impact market growth and demand for guaifenesin-based products[1].

Potential Side Effects

Guaifenesin and pseudoephedrine hydrochloride combinations can have side effects, such as dizziness, stomach problems, and interactions with other medications. These side effects need to be carefully managed to ensure patient safety[2][5].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the global guaifenesin market. Initially, production halts and supply chain disruptions affected the market. However, the surging demand for cough and cold medications during the recovery phase led to major growth opportunities. The pandemic highlighted the importance of effective expectorants like guaifenesin in managing respiratory symptoms[1].

Emerging Markets and Opportunities

Emerging economies, such as India and Brazil, present significant growth opportunities for the guaifenesin market. Increasing healthcare awareness and rising incidences of respiratory conditions in these regions drive the demand for expectorants like guaifenesin. The Indian pharmaceutical sector, in particular, is projected to grow at a CAGR of 10%, indicating a robust market for over-the-counter medications[3].

Key Takeaways

  • The global guaifenesin market is expected to grow significantly, driven by the increasing prevalence of respiratory conditions and advancements in the pharmaceutical sector.
  • North America is the fastest-growing region, driven by developing medical infrastructure and rising health expenditure.
  • Combination therapies with pseudoephedrine hydrochloride enhance the market demand for guaifenesin.
  • Emerging markets offer substantial growth opportunities due to increasing healthcare awareness and rising respiratory conditions.

FAQs

What is the primary use of guaifenesin and pseudoephedrine hydrochloride combination?

The primary use is to relieve cough and nasal congestion caused by the common cold, hay fever, and upper respiratory allergies[2][4].

How is the global guaifenesin market expected to grow?

The global guaifenesin market is expected to grow at a CAGR of around 7.4% from 2023 to 2033, reaching approximately USD 2.7 billion by 2033[3].

What are the main drivers of the guaifenesin market?

The main drivers include the increasing prevalence of respiratory conditions, advancements in the pharmaceutical sector, and the effectiveness of combination therapies[1][3].

Which region leads the guaifenesin market?

North America leads the guaifenesin market, driven by developing medical infrastructure and rising health expenditure[1].

What are the potential side effects of guaifenesin and pseudoephedrine hydrochloride combination?

Potential side effects include dizziness, stomach problems, and interactions with other medications. It is crucial to use these medications with caution, especially in elderly patients and those with certain health conditions[2][5].

Cited Sources

  1. IndustryARC: Guaifenesin Market Size Report, 2022-2027.
  2. Mayo Clinic: Hydrocodone, pseudoephedrine, and guaifenesin (oral route).
  3. Market.US: Global Guaifenesin Market Size, Share | CAGR Of 7.4%.
  4. Cleveland Clinic: Guaifenesin; Pseudoephedrine (Mucinex D) tablets or capsules.
  5. DailyMed: Mucinex D Maximum Strength - guaifenesin and pseudoephedrine hydrochloride tablet, extended release.

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