Benzonatate - Generic Drug Details

What are the generic drug sources for benzonatate and what is the scope of freedom to operate?

Benzonatate is the generic ingredient in two branded drugs marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, Zydus Pharms Usa, and Pfizer, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for benzonatate. Forty-three suppliers are listed for this compound.

Summary for benzonatate

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	4
Patent Applications:	3,342
Drug Prices:	Drug price trends for benzonatate
Drug Sales Revenues:	Drug sales revenues for benzonatate
What excipients (inactive ingredients) are in benzonatate?	benzonatate excipients list
DailyMed Link:	benzonatate at DailyMed

See drug prices for benzonatate

See drug sales revenues for benzonatate

Recent Clinical Trials for benzonatate

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

Sponsor	Phase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Pfizer	Phase 1

See all benzonatate clinical trials

Pharmacology for benzonatate

Drug Class	Non-narcotic Antitussive
Physiological Effect	Decreased Tracheobronchial Stretch Receptor Activity

Anatomical Therapeutic Chemical (ATC) Classes for benzonatate

R05DB	Other cough suppressants
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for benzonatate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mikart	BENZONATATE	benzonatate	CAPSULE;ORAL	040851-001	Nov 9, 2009		DISCN	No	No
Heritage Pharms Labs	BENZONATATE	benzonatate	CAPSULE;ORAL	040682-002	Jul 30, 2007	AA	RX	No	No
Ascent Pharms Inc	BENZONATATE	benzonatate	CAPSULE;ORAL	211518-002	Feb 22, 2019		RX	No	No
Puracap Pharm Llc	BENZONATATE	benzonatate	CAPSULE;ORAL	206948-002	Dec 19, 2018	AA	RX	No	Yes

Benzonatate Market Analysis and Financial Projection Experimental

Benzonatate Market Dynamics and Financial Trajectory

Introduction

Benzonatate, a cough suppressant belonging to the antitussive agents class, has been a significant player in the pharmaceutical market, particularly in the context of relieving coughs associated with colds and influenza. Here, we delve into the market dynamics and financial trajectory of benzonatate, highlighting key trends, drivers, and regional performances.

Global Market Size and Growth Rate

The global benzonatate capsules market is projected to exhibit a positive growth trajectory. As of 2024, the market size is estimated to be USD XX million and is expected to expand at a compound annual growth rate (CAGR) of 4.30% from 2024 to 2031[1].

Regional Market Performance

The growth of the benzonatate market varies across different regions:

• North America: Expected to grow at a CAGR of 2.5% from 2024 to 2031, driven by established healthcare systems and consumer awareness of over-the-counter medications[1].
• Europe: Forecasted to grow at a CAGR of 2.8% during the same period, influenced by the region's robust healthcare infrastructure and increasing demand for cough suppressants[1].
• Asia Pacific: This region is anticipated to experience the highest growth rate, with a CAGR of 6.3% from 2024 to 2031, largely due to the rapid expansion of the biopharmaceutical sector in countries like China[1].
• Latin America: The market in this region is expected to grow at a CAGR of 3.7%, fueled by rising demand for easily accessible cough suppressants and investments in healthcare infrastructure[1].
• Middle East and Africa: This region is projected to grow at a CAGR of 4.0%, driven by increasing awareness of cough suppressants and strategic investments in healthcare research[1].

Key Drivers

Several factors are driving the growth of the benzonatate market:

• Rising Geriatric Population: The increasing age of the global population is leading to higher incidence rates of respiratory disorders, thereby boosting the demand for cough suppressants like benzonatate[3].
• Healthcare Access and Infrastructure: Improvements in healthcare access and infrastructure, especially in emerging markets, are facilitating the growth of the benzonatate market[1][4].
• Over-the-Counter (OTC) Market: The convenience and accessibility of OTC medications are contributing significantly to the market's expansion. Many consumers prefer self-care alternatives, which include benzonatate capsules[1][4].

Impact of COVID-19

The COVID-19 pandemic had a dual impact on the benzonatate market. Initially, the demand for cough suppressants surged as people sought relief from respiratory symptoms associated with the virus. However, supply chain disruptions and healthcare access issues also affected market dynamics. Despite these challenges, the market has shown resilience and is expected to continue growing in the forecast period[1].

Cost and Insurance Coverage

The cost of benzonatate can vary based on several factors, including the pharmacy, treatment plan, and insurance coverage. Benzonatate is available as a generic drug, which is generally cheaper than its brand-name counterpart, Tessalon. Insurance coverage, such as Medicare, may also influence the cost, with some plans requiring prior authorization[2].

Major Players

The benzonatate market is competitive, with several key players:

• Pfizer
• Zydus Pharmaceuticals
• Sun Pharmaceutical
• Ascend Laboratories
• Apotex
• Bionpharma

These companies are driving innovation and competition in the market through their production and distribution capabilities[4].

Dosage Forms and Applications

Benzonatate is available in various dosage forms, including liquid-filled capsules. It is primarily used to relieve coughs due to colds or influenza and is not recommended for chronic coughs associated with smoking, asthma, or emphysema[5].

Side Effects and Precautions

While benzonatate is effective in relieving coughs, it can cause several side effects, including confusion, difficult breathing, and dizziness. It is crucial for patients to follow their doctor's instructions and monitor their progress to avoid any adverse effects[5].

Market Segmentation

The benzonatate market is segmented by type (100mg and 200mg capsules) and application (prescription and over-the-counter). This segmentation helps in understanding the different market dynamics and consumer preferences[4].

Financial Resources and Assistance

For patients who need financial assistance to purchase benzonatate, several resources are available, including drug assistance programs and savings cards. These resources can help make the medication more affordable and accessible[2].

Key Takeaways

• The global benzonatate capsules market is expected to grow at a CAGR of 4.30% from 2024 to 2031.
• Regional growth rates vary, with the Asia Pacific region showing the highest CAGR.
• Key drivers include the rising geriatric population and improvements in healthcare access and infrastructure.
• The COVID-19 pandemic had a mixed impact on the market, with initial demand surges followed by supply chain disruptions.
• Major players like Pfizer and Zydus Pharmaceuticals are driving market competition.
• Benzonatate is available in various dosage forms and is primarily used for relieving coughs due to colds or influenza.

FAQs

1. What is the primary use of benzonatate?

Benzonatate is primarily used to relieve coughs due to colds or influenza. It is not recommended for chronic coughs associated with smoking, asthma, or emphysema[5].

2. How does the cost of benzonatate vary?

The cost of benzonatate can vary based on factors such as the pharmacy, treatment plan, and insurance coverage. Generic versions are generally cheaper than brand-name versions[2].

3. Which regions are expected to show the highest growth in the benzonatate market?

The Asia Pacific region is anticipated to show the highest growth rate, with a CAGR of 6.3% from 2024 to 2031, driven by the rapid expansion of the biopharmaceutical sector[1].

4. What are the common side effects of benzonatate?

Common side effects include confusion, difficult breathing, dizziness, and nausea or vomiting. Severe side effects can include convulsions, loss of consciousness, and shortness of breath[5].

5. Are there any financial assistance programs available for purchasing benzonatate?

Yes, several financial assistance programs and resources are available to help make benzonatate more affordable, including drug assistance programs and savings cards[2].

Cited Sources:

1. Cognitive Market Research, Benzonatate Capsules Market Report 2024 (Global Edition), May 8, 2024.
2. MedicalNewsToday, Benzonatate cost 2024: Coupons and more, October 24, 2023.
3. Stats and Data, Global Benzonatate Market Growth Opportunities 2024-2031.
4. OpenPR, Benzonatate Capsules Market Forecast 2023-2029: Demand, Business Growth, Opportunity, Application, Cost, sales, Type, Size, Top Manufacturers Analysis, April 3, 2023.
5. Mayo Clinic, Benzonatate (oral route), February 1, 2024.