Guaifenesin; hydrocodone bitartrate - Generic Drug Details

What are the generic drug sources for guaifenesin; hydrocodone bitartrate and what is the scope of freedom to operate?

Guaifenesin; hydrocodone bitartrate is the generic ingredient in four branded drugs marketed by Chartwell Rx, Sovereign Pharms, and Eci Pharms Llc, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for guaifenesin; hydrocodone bitartrate

US Patents:	3
Tradenames:	4
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	guaifenesin; hydrocodone bitartrate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for guaifenesin; hydrocodone bitartrate

Constraining patent/regulatory exclusivity:

9,549,907

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for guaifenesin; hydrocodone bitartrate

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

Sponsor	Phase
Reckitt Benckiser LLC	Phase 1

See all guaifenesin; hydrocodone bitartrate clinical trials

Pharmacology for guaifenesin; hydrocodone bitartrate

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

Anatomical Therapeutic Chemical (ATC) Classes for guaifenesin; hydrocodone bitartrate

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

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for guaifenesin; hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No	10,105,324		Y	Y
Eci Pharms Llc	XTRELUS	guaifenesin; hydrocodone bitartrate	TABLET;ORAL	208085-001	Apr 25, 2018		DISCN	Yes	No
Chartwell Rx	FLOWTUSS	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	022424-001	May 14, 2015		DISCN	No	No

Guaifenesin; hydrocodone bitartrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Guaifenesin and Hydrocodone Bitartrate

Introduction

Guaifenesin and hydrocodone bitartrate are two active pharmaceutical ingredients commonly combined in medications to treat cough and respiratory issues. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview of Guaifenesin

Guaifenesin, an expectorant, is widely used in treating cough, bronchitis, and chest congestion. Here are some key points about the guaifenesin market:

Global Market Size and Growth

The global guaifenesin market is projected to reach USD 95 million by 2027, growing at a CAGR of around 3.1% from 2022 to 2027[3].

Applications and Demand

Guaifenesin is used in various forms such as syrups, tablets, dissolving granules, and extended-release tablets. The demand for guaifenesin is driven by its application in cough treatment drugs, particularly in hospitals, clinics, and other healthcare settings. The North American region is the fastest-growing market due to its developing medical infrastructure and increasing cases of respiratory and cough-related complications[3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the guaifenesin market. Initially, the pandemic caused disruptions in production and supply chains, but the subsequent increase in demand for cough and cold medications during the recovery phase led to growth opportunities in the market. Medicaid spending and hospital expenditures increased significantly during this period, contributing to the market's growth[3].

Market Dynamics of Hydrocodone Bitartrate and Guaifenesin Combination

The combination of hydrocodone bitartrate and guaifenesin is used for the symptomatic relief of cough associated with common colds and other respiratory conditions.

Regulatory Considerations

Due to the opioid component (hydrocodone bitartrate), these medications are subject to strict regulatory oversight. The FDA requires careful assessment of the risks of addiction, abuse, and misuse, even at recommended doses. Prescribers must monitor patients regularly and prescribe the drug for the shortest duration consistent with treatment goals[2].

Clinical Use and Dosing

The dosing regimen for guaifenesin and hydrocodone bitartrate oral solution typically involves 10 mL every 4 to 6 hours for patients 18 years and older, not to exceed 6 doses (60 mL) in 24 hours. The combination is contraindicated in children under 6 years due to the risk of life-threatening respiratory depression[1][2].

Financial Trajectory

Revenue Projections

The financial trajectory of guaifenesin and hydrocodone bitartrate combination products is influenced by several factors, including market demand, regulatory environment, and competition.

• The growing demand for cough treatment drugs, especially in regions like North America, is expected to drive revenue growth. The global guaifenesin market's projected growth to USD 95 million by 2027 indicates a positive financial outlook[3].

Pharmaceutical Sector Growth

The pharmaceutical sector, particularly in India and other emerging markets, is expected to see significant growth. The Indian pharmaceutical sector is projected to reach USD 65 billion by 2024 and around USD 120-130 billion by 2030, which will further boost the demand for guaifenesin and hydrocodone bitartrate combination products[3].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as the availability of substitutes and potential side effects. However, advancements in medical and pharmaceutical technologies, along with increasing healthcare expenditure, offer significant opportunities for growth[3].

Regional Market Analysis

North America

North America is the fastest-growing region for the guaifenesin market, driven by developing medical infrastructure, growing cases of respiratory and cough-related complications, and rising health expenditure. This region is expected to grow with a CAGR of around 4.5% during the forecast period[3].

Other Regions

Other regions, including Asia-Pacific and Europe, also show promising growth due to increasing demand for cough treatment medications and advancements in healthcare infrastructure.

Competitive Landscape

The market for guaifenesin and hydrocodone bitartrate combination products is competitive, with several pharmaceutical companies offering various formulations. Companies must navigate regulatory requirements, ensure product safety, and innovate to stay competitive.

Consumer and Patient Impact

Patient Benefits

For patients, the combination of guaifenesin and hydrocodone bitartrate provides effective relief from cough and respiratory symptoms. However, patients must be aware of the risks associated with opioid use and follow prescribed dosing regimens carefully[2].

Patient Counseling

Healthcare providers play a crucial role in counseling patients about the proper use of these medications, the risks of addiction and abuse, and the importance of disposing of unused medication properly[2].

Key Takeaways

• The global guaifenesin market is projected to grow significantly, driven by increasing demand for cough treatment medications.
• The combination of guaifenesin and hydrocodone bitartrate is subject to strict regulatory oversight due to the opioid component.
• North America is the fastest-growing region for this market.
• Advancements in healthcare infrastructure and increasing healthcare expenditure are key drivers of market growth.
• Challenges include the availability of substitutes and potential side effects.

FAQs

1. What is the primary use of guaifenesin and hydrocodone bitartrate combination products?

The primary use of guaifenesin and hydrocodone bitartrate combination products is for the symptomatic relief of cough associated with common colds and other respiratory conditions.

2. What are the regulatory considerations for these medications?

These medications are subject to strict regulatory oversight due to the opioid component (hydrocodone bitartrate), requiring careful assessment of the risks of addiction, abuse, and misuse[2].

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

The COVID-19 pandemic initially caused disruptions in production and supply chains but later led to increased demand for cough and cold medications, driving growth in the market[3].

4. What are the key regions driving the growth of the guaifenesin market?

North America is the fastest-growing region for the guaifenesin market, driven by developing medical infrastructure and increasing cases of respiratory and cough-related complications[3].

5. What are the potential challenges facing the guaifenesin market?

The market faces challenges such as the availability of substitutes and potential side effects, but advancements in medical and pharmaceutical technologies offer significant opportunities for growth[3].

Cited Sources:

1. FDA: "Guaifenesin and Hydrocodone Bitartrate Oral Solution" - FDA Review[1].
2. FDA: "Hydrocodone Bitartrate and Guaifenesin Tablets" - Label[2].
3. IndustryARC: "Guaifenesin Market Size Report, 2022-2027"[3].
4. RxList: "Hycotuss (Hydrocodone Bitartrate and Guaifenesin) - Expectorant Syrup"[4].
5. University of Maryland, Baltimore: "Guaifenesin" - Report[5].