VENTOLIN Drug Patent Profile

When do Ventolin patents expire, and what generic alternatives are available?

Ventolin is a drug marketed by Glaxosmithkline and is included in seven NDAs.

The generic ingredient in VENTOLIN is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ventolin

A generic version of VENTOLIN was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for VENTOLIN

US Patents:	0
Applicants:	1
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	51
Patent Applications:	4,136
Drug Prices:	Drug price information for VENTOLIN
Drug Sales Revenues:	Drug sales revenues for VENTOLIN
What excipients (inactive ingredients) are in VENTOLIN?	VENTOLIN excipients list
DailyMed Link:	VENTOLIN at DailyMed

See drug prices for VENTOLIN

See drug sales revenues for VENTOLIN

Recent Clinical Trials for VENTOLIN

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

Sponsor	Phase
University of Alberta	Phase 1
Canisius-Wilhelmina Hospital	Phase 3
Hat Yai Medical Education Center	Phase 3

See all VENTOLIN clinical trials

US Patents and Regulatory Information for VENTOLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	VENTOLIN	albuterol	AEROSOL, METERED;INHALATION	018473-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987		DISCN	No	No
Glaxosmithkline	VENTOLIN ROTACAPS	albuterol sulfate	CAPSULE;INHALATION	019489-001	May 4, 1988		DISCN	No	No
Glaxosmithkline	VENTOLIN	albuterol sulfate	SOLUTION;INHALATION	019773-001	Apr 23, 1992		DISCN	Yes	No
Glaxosmithkline	VENTOLIN	albuterol sulfate	SOLUTION;INHALATION	019269-002	Jan 16, 1987		DISCN	No	No

Expired US Patents for VENTOLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-002	Jul 10, 1986
Glaxosmithkline	VENTOLIN	albuterol	AEROSOL, METERED;INHALATION	018473-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-001	Jul 10, 1986
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-001	Jul 10, 1986
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987

International Patents for VENTOLIN

See the table below for patents covering VENTOLIN around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	656308	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU SALBUTAMOL.
Germany	1643224
Israel	68805
Germany	3319356	Wäßrige Arzneimittelzubereitung, enthaltend als Wirkstoff Salbutamol und/oder ein oder mehrere physiologisch annehmbare Salze davon
Cyprus	806	PHENYLAMINOETHANOL DERIVATIVES
Belgium	752892

VENTOLIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Albuterol (Ventolin)

Introduction to Albuterol (Ventolin)

Albuterol, commonly known by the brand name Ventolin, is a widely used medication for the treatment and prevention of symptoms associated with respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and bronchitis. Here, we delve into the market dynamics and financial trajectory of albuterol, highlighting key drivers, opportunities, and projections.

Increasing Prevalence of Respiratory Diseases

The global prevalence of respiratory diseases is on the rise, creating a significant demand for albuterol. Conditions like asthma and COPD are becoming more common, driven by factors such as lifestyle changes, environmental pollution, and genetic predispositions. This increasing patient population is a major driver for the growth of the albuterol market[1].

Growing Awareness and Diagnosis

Advancements in healthcare facilities, awareness campaigns, and diagnostic techniques have led to better detection and management of respiratory diseases. Early diagnosis and treatment have increased the number of patients being prescribed albuterol, contributing to market growth[1].

Lifestyle Changes and Environmental Factors

Modern lifestyles, characterized by sedentary habits, poor dietary choices, and exposure to pollutants, exacerbate respiratory conditions. Smoking, occupational hazards, and urbanization further increase the risk of these diseases, making albuterol a crucial medication for symptom management[1].

Government Initiatives and Healthcare Expenditure

Governments and healthcare organizations are actively involved in addressing the burden of respiratory diseases through awareness campaigns, research support, and healthcare budget allocations. These initiatives enhance access to albuterol medications, driving market expansion[1].

Market Size and Growth Projections

The albuterol market was valued at USD 4,587.68 million in 2022 and is expected to grow to USD 7,984.37 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.80% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases and the expanding patient population[1].

Segmentation of the Albuterol Market

The market is segmented based on several factors, including:

• Indications: Asthma, COPD, and other respiratory conditions.
• Product Type: Various concentrations of albuterol sulfate inhalation solutions.
• Type: Generic and branded products.
• Dosage: Oral, inhalation, and other forms.
• End-Users: Hospitals, specialty clinics, home healthcare, and others.
• Distribution Channels: Direct tender, hospital pharmacy, retail pharmacy, online pharmacy, and others[1].

Dominance of Oral Dosage

The oral dosage segment is the second most preferred mode of administration among clinicians and patients, contributing significantly to the market value. This preference is due to the ease of administration and patient compliance[1].

Opportunities in Combination Therapies

Combination therapies that include albuterol along with other medications, such as corticosteroids or long-acting bronchodilators, offer significant opportunities for market growth. These therapies provide enhanced efficacy and convenience, simplifying treatment regimens for patients[1].

Financial Performance of Key Players

Companies like GSK, which are major players in the respiratory medication market, have shown strong financial performance. For instance, GSK's sales in the general medicines segment, which includes respiratory drugs, grew by 5% in 2022, contributing to the company's overall revenue[2].

Impact of Regulatory Frameworks

Regulatory approvals and changes in healthcare policies significantly influence the albuterol market. For example, the FDA's approval of new treatments and the acceptance of new drug applications, such as Verona Pharma's Ensifentrine for COPD, can impact market dynamics and growth[4].

Global and Regional Market Share

The global asthma drugs market, which includes albuterol, is projected to grow significantly. North America, particularly the U.S., holds a substantial market share due to the high prevalence of asthma and other respiratory diseases. The U.S. asthma drugs market alone is expected to surpass USD 14.75 billion by 2033, growing at a CAGR of 5.12%[4].

Spending Trends in Pharmaceutical Markets

The overall pharmaceutical market, including respiratory medications, has seen significant spending growth driven by innovation, price increases, and lower patent expiry impacts. Specialty medicines, which include advanced treatments for respiratory diseases, have contributed substantially to this growth, with spending increasing by 26.5% in recent years[3].

Key Takeaways

• The albuterol market is driven by the increasing prevalence of respiratory diseases and improved diagnosis and treatment options.
• Government initiatives and healthcare expenditure play a crucial role in market growth.
• Combination therapies offer significant opportunities for market expansion.
• The oral dosage segment is a key contributor to the market value.
• Regulatory frameworks and approvals are critical for market dynamics.
• The global and U.S. markets for asthma drugs, including albuterol, are projected to grow substantially over the next decade.

FAQs

What is the projected growth rate of the albuterol market?

The albuterol market is expected to grow at a CAGR of 6.80% from 2023 to 2030[1].

Which segment dominates the albuterol market in terms of dosage?

The oral dosage segment is the second most preferred mode of administration and significantly contributes to the market value[1].

How do lifestyle changes impact the demand for albuterol?

Lifestyle changes such as sedentary habits, poor dietary choices, and exposure to environmental pollutants contribute to the development and exacerbation of respiratory diseases, increasing the demand for albuterol[1].

What role do combination therapies play in the albuterol market?

Combination therapies that include albuterol offer enhanced efficacy and convenience, providing opportunities for market growth and catering to the evolving needs of healthcare providers and patients[1].

How does government healthcare expenditure influence the albuterol market?

Government initiatives and healthcare expenditure enhance access to albuterol medications, driving market growth by promoting awareness campaigns, supporting research and development, and allocating healthcare budgets for respiratory disease management[1].

Sources

1. Data Bridge Market Research: Global Albuterol Market – Industry Trends and Forecast to 2030.
2. GSK: Full-year and fourth quarter 2022 results announcement.
3. Vermont Legislature: Medicines Use and Spending Shifts.
4. BioSpace: U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033.