VENTOLIN HFA Drug Patent Profile

When do Ventolin Hfa patents expire, and when can generic versions of Ventolin Hfa launch?

Ventolin Hfa is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in VENTOLIN HFA 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 Hfa

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

Summary for VENTOLIN HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	51
Patent Applications:	5,671
Drug Prices:	Drug price information for VENTOLIN HFA
Drug Sales Revenues:	Drug sales revenues for VENTOLIN HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VENTOLIN HFA
What excipients (inactive ingredients) are in VENTOLIN HFA?	VENTOLIN HFA excipients list
DailyMed Link:	VENTOLIN HFA at DailyMed

See drug prices for VENTOLIN HFA

See drug sales revenues for VENTOLIN HFA

Recent Clinical Trials for VENTOLIN HFA

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 HFA clinical trials

Pharmacology for VENTOLIN HFA

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

US Patents and Regulatory Information for VENTOLIN HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes

Expired US Patents for VENTOLIN HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,435,372*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	7,350,676*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	7,107,986*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,131,566*PED

International Patents for VENTOLIN HFA

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

Country	Patent Number	Title	Estimated Expiration
Japan	4423457
European Patent Office	1220802	DISPOSITIF DE LOGEMENT D'UN APPAREIL POUR CONTENANT D'AEROSOL (DEVICE HOUSING FOR AN AEROSOL CONTAINER)
Cyprus	2566	Aerosol compositions
Hungary	228280	DISPENSER WITH DOSES COUNTER

VENTOLIN HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ventolin HFA

Introduction

Ventolin HFA, a widely used inhaler for treating asthma and chronic obstructive pulmonary disease (COPD), is a cornerstone in the respiratory medication market. To understand its market dynamics and financial trajectory, it is essential to delve into various factors influencing its demand, competition, and financial performance.

Increasing Prevalence of Respiratory Diseases

The global prevalence of respiratory diseases such as asthma and COPD continues to rise, creating a significant demand for medications like Ventolin HFA. This trend is driven by factors such as lifestyle changes, environmental pollutants, and an aging population[4].

Market Size and Growth

The market for metered dose inhalers (MDIs), which includes Ventolin HFA, has seen substantial growth. From 2015 to 2020, the sales of MDIs in the United States increased by 75%, from 80 million units to 140 million units. This growth is largely attributed to the increasing need for effective management of respiratory diseases[1].

Propellant Usage and Regulatory Impact

Ventolin HFA uses hydrofluorocarbons (HFCs) as propellants, specifically HFC-134a. The use of HFCs in MDIs accounts for a small but significant portion of total HFC emissions. Regulatory changes and environmental concerns may influence the future use of HFCs, potentially impacting the production and sales of Ventolin HFA. However, current projections suggest that HFC MDIs will continue to be used, albeit with a growth rate of approximately 1% per year through 2025[1].

Financial Performance of Key Players

Companies like GlaxoSmithKline (GSK), the manufacturer of Ventolin HFA, have reported strong financial performance in recent years. GSK's respiratory segment, which includes Ventolin HFA, has contributed significantly to the company's revenue. For instance, in 2022, GSK's General Medicines segment, which includes respiratory products, generated £10.1 billion in sales, representing a 5% increase in actual exchange rates (AER) and 1% in constant exchange rates (CER)[2].

Competitive Landscape

The market for respiratory medications is highly competitive, with various brands and generic alternatives available. The acquisition of licensing rights and distribution agreements, such as Sandoz's acquisition of licensing rights for Proventil HFA, indicates a dynamic market where companies are continually seeking to expand their market share[1].

Smart Inhalers and Technological Advancements

The emergence of smart inhalers is transforming the respiratory medication market. While Ventolin HFA is a traditional MDI, the growing demand for smart inhalers, which offer features like dose tracking and adherence monitoring, presents both opportunities and challenges. The global smart inhalers market is projected to grow significantly, with a compound annual growth rate (CAGR) of 37.0% from 2019 to 2027[3].

Distribution Channels

The distribution of Ventolin HFA is primarily through hospital pharmacies and retail pharmacies. Hospital pharmacies, in particular, are expected to continue playing a crucial role due to their accessibility to the patient population undergoing treatments in hospital settings[3].

Government Initiatives and Healthcare Expenditure

Government initiatives and increased healthcare expenditure on respiratory diseases support the market growth of medications like Ventolin HFA. These initiatives include awareness campaigns, support for research and development, and allocation of healthcare budgets for managing respiratory conditions[4].

Combination Therapies

The trend towards combination therapies, which include albuterol (the active ingredient in Ventolin HFA) along with other medications like corticosteroids or long-acting bronchodilators, offers opportunities for market expansion. These combination therapies provide enhanced efficacy and convenience, catering to the evolving needs of healthcare providers and patients[4].

Key Takeaways

• Increasing Demand: Rising prevalence of respiratory diseases drives the demand for Ventolin HFA.
• Regulatory Considerations: Environmental regulations may impact the use of HFC propellants in MDIs.
• Financial Performance: Strong revenue growth from respiratory segments for key players like GSK.
• Competitive Market: Dynamic market with various brands and generic alternatives.
• Technological Advancements: Emergence of smart inhalers presents opportunities and challenges.
• Distribution Channels: Hospital and retail pharmacies remain key distribution channels.
• Government Support: Initiatives and healthcare expenditure support market growth.

FAQs

What is the primary active ingredient in Ventolin HFA?

The primary active ingredient in Ventolin HFA is albuterol sulfate.

How has the market for MDIs like Ventolin HFA grown in recent years?

The sales of MDIs in the United States increased by 75% from 2015 to 2020, from 80 million units to 140 million units[1].

What are the key factors driving the demand for Ventolin HFA?

The increasing prevalence of respiratory diseases, lifestyle changes, and government initiatives are key factors driving the demand for Ventolin HFA[4].

How do regulatory changes impact the use of HFCs in MDIs like Ventolin HFA?

Regulatory changes may influence the future use of HFCs, but current projections suggest that HFC MDIs will continue to be used with a growth rate of approximately 1% per year through 2025[1].

What is the role of smart inhalers in the market for respiratory medications?

Smart inhalers offer features like dose tracking and adherence monitoring, presenting both opportunities and challenges for traditional MDIs like Ventolin HFA. The global smart inhalers market is projected to grow significantly[3].

Sources

1. EPA - Market Characterization of the U.S. Metered Dose Inhaler Industry
2. GSK - Full-year and fourth quarter 2022 results announcement
3. Fortune Business Insights - Smart Inhalers Market Size, Share & Growth | Global Report, 2032
4. Data Bridge Market Research - Global Albuterol Market – Industry Trends and Forecast to 2030