PROAIR HFA Drug Patent Profile

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

Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twelve patent family members in twenty-six countries.

The generic ingredient in PROAIR 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 Proair Hfa

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

Summary for PROAIR HFA

International Patents:	212
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	14
Patent Applications:	5,671
Drug Prices:	Drug price information for PROAIR HFA
Drug Sales Revenues:	Drug sales revenues for PROAIR HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR HFA
DailyMed Link:	PROAIR HFA at DailyMed

See drug prices for PROAIR HFA

See drug sales revenues for PROAIR HFA

Recent Clinical Trials for PROAIR HFA

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

Sponsor	Phase
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	Early Phase 1
Wake Forest University Health Sciences	Early Phase 1

See all PROAIR HFA clinical trials

Pharmacology for PROAIR HFA

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

Paragraph IV (Patent) Challenges for PROAIR HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROAIR HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	021457	1	2012-05-18

US Patents and Regulatory Information for PROAIR HFA

PROAIR HFA is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y

Expired US Patents for PROAIR HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004

International Patents for PROAIR HFA

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	016831	ДОЗИРУЮЩИЙ ИНГАЛЯТОР (METERED-DOSE INHALER)
United Kingdom	8828477
Spain	2175413
South Korea	20160066563

PROAIR HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ProAir HFA

Introduction

ProAir HFA, a widely used bronchodilator, is a crucial medication in the management of asthma and chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of ProAir HFA, examining the broader context of the asthma and bronchodilators market.

Market Overview of Bronchodilators

The global bronchodilators market is experiencing significant growth, driven by factors such as the increasing prevalence of lung diseases, a growing geriatric population, and heightened awareness about lung disease treatment. As of 2022, the global bronchodilators market was valued at USD 22.19 billion and is expected to expand at a compound annual growth rate (CAGR) of 3.29% until 2030, reaching USD 28.75 billion[4].

ProAir HFA in the Bronchodilators Market

ProAir HFA, which contains albuterol, is a short-acting beta-2 agonist (SABA) that dominates the bronchodilators market. Beta-adrenergic bronchodilators, including ProAir HFA, held a market share of 41.15% in 2022. These medications target smooth muscle cell receptors to dilate airways, providing quick relief for asthma and COPD symptoms[4].

U.S. Asthma Drugs Market

In the United States, the asthma drugs market is substantial and growing. The market size was valued at USD 8.95 billion in 2023 and is projected to surpass USD 14.75 billion by 2033, with a CAGR of 5.12% over the forecast period. This growth is driven by the high prevalence of asthma, affecting approximately 25 million individuals in the U.S.[3].

Sales and Revenue Trends

ProAir HFA, as part of the broader bronchodilators market, benefits from the increasing demand for asthma and COPD treatments. The U.S. market for bronchodilators is expected to grow at a CAGR of 2.91% from 2022 to 2030. This growth is partly attributed to the off-label use of bronchodilators during the COVID-19 pandemic, which highlighted the importance of respiratory medications[4].

Financial Performance of Key Players

Teva Pharmaceutical Industries, the manufacturer of ProAir HFA, has reported mixed financial results in recent years. In the third quarter of 2023, Teva saw a 7% increase in revenues compared to the same period in 2022, reaching $3.9 billion. However, operating income decreased due to higher legal settlements, R&D, and sales & marketing expenses. Non-GAAP operating income was $1,020 million, representing a non-GAAP operating margin of 26.5%[5].

Impact of Regulatory and Environmental Factors

The use of hydrofluorocarbons (HFCs) in metered-dose inhalers (MDIs) like ProAir HFA has been under regulatory scrutiny due to their contribution to greenhouse gas emissions. In the U.S., HFC MDIs account for a small but significant portion of total HFC use. The EPA has noted that while alternative propellants are being developed, HFC MDIs are expected to retain their market size with a growth rate of approximately 1% per year through 2025[1].

Competitive Landscape

The bronchodilators market is highly competitive, with several key players including Teva, GlaxoSmithKline, and AstraZeneca. The launch of advanced inhaler bronchodilators, such as Zydus Cadila's Forglyn pMDI, further intensifies the competition. However, ProAir HFA remains a dominant player due to its established brand and widespread use[4].

Public Sector Influence

The public sector plays a crucial role in the U.S. asthma drugs market by providing essential support for asthma treatment and management initiatives. Increased funding for public programs aims to enhance the quality of asthma care, reduce emergency visits, and improve patient outcomes. This proactive approach by the public sector underscores its significance in driving growth within the market[3].

Consumer Demand and Awareness

Consumer awareness about lung diseases and the importance of proper treatment is on the rise. This increased awareness, coupled with the growing prevalence of asthma and COPD, drives the demand for bronchodilators like ProAir HFA. The COVID-19 pandemic has further highlighted the importance of respiratory health, contributing to the market's growth[4].

Technological Advancements

The development of new inhaler technologies and alternative propellants is a key trend in the bronchodilators market. For instance, the transition from HFC-based MDIs to more environmentally friendly options is ongoing. These advancements are expected to influence the market dynamics and potentially impact the sales of ProAir HFA and similar products[1].

Key Takeaways

• Market Growth: The global bronchodilators market, including ProAir HFA, is expected to grow at a CAGR of 3.29% until 2030.
• Regulatory Impact: HFC regulations may influence the future of MDIs like ProAir HFA, though they are expected to retain market size with a 1% annual growth rate.
• Financial Performance: Teva's financial results indicate a mixed performance, with revenue growth but decreased operating income due to various expenses.
• Public Sector Role: Public funding and initiatives are crucial in driving the U.S. asthma drugs market and improving patient outcomes.
• Consumer Awareness: Increased awareness about lung diseases and the COVID-19 pandemic's impact on respiratory health are driving market growth.

FAQs

1. What is the projected growth rate of the global bronchodilators market? The global bronchodilators market is expected to grow at a CAGR of 3.29% from 2023 to 2030[4].

2. How does ProAir HFA fit into the broader bronchodilators market? ProAir HFA is a short-acting beta-2 agonist (SABA) that dominates the bronchodilators market, with beta-adrenergic bronchodilators holding a 41.15% market share in 2022[4].

3. What are the key drivers of the U.S. asthma drugs market? The U.S. asthma drugs market is driven by the high prevalence of asthma, public sector initiatives, and increased awareness about lung disease treatment[3].

4. How have regulatory factors impacted the use of HFCs in MDIs like ProAir HFA? Regulatory efforts aim to reduce HFC use due to their environmental impact, but HFC MDIs are expected to retain their market size with a 1% annual growth rate through 2025[1].

5. What role does the public sector play in the U.S. asthma drugs market? The public sector provides essential support for asthma treatment and management initiatives, aiming to enhance care quality, reduce emergency visits, and improve patient outcomes[3].

Sources

1. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry[1].
2. Teva Pharmaceutical Industries: Teva Reports Third Quarter 2020 Financial Results[2].
3. BioSpace: U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033[3].
4. Grand View Research: Bronchodilators Market Size & Trends Analysis Report, 2030[4].
5. Teva Pharmaceutical Industries: Teva Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance[5].