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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-two patent family members in twenty-four countries.

The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-six 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:	192
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	14
Patent Applications:	3,834
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
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	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 four 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
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	201300232	ВАЛ ДЛЯ УДЕРЖИВАНИЯ ЛЕНТЫ СЧЕТЧИКА В СЧЕТЧИКЕ ДОЗ, СБОРОЧНЫЙ УЗЕЛ ВАЛА И ЛЕНТЫ СЧЕТЧИКА, СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННОГО ВЕЩЕСТВА
Japan	6273242
Eurasian Patent Organization	201300236	ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННОГО ВЕЩЕСТВА И СПОСОБ СБОРКИ ИНГАЛЯТОРА
Eurasian Patent Organization	200970907	ДОЗИРУЮЩИЙ ИНГАЛЯТОР
China	105903110
Croatia	P20150102

Market Dynamics and Financial Trajectory for PROAIR HFA

Last updated: July 3, 2025

Introduction

PROAIR HFA, a widely prescribed albuterol sulfate inhaler, serves as a critical rescue medication for asthma and chronic obstructive pulmonary disease (COPD) patients. Developed by Teva Pharmaceuticals following its acquisition from previous manufacturers, this drug has shaped respiratory care markets since its FDA approval in 2004. As global respiratory conditions rise due to environmental factors and aging populations, understanding PROAIR HFA's market dynamics and financial trajectory equips business professionals with actionable insights. This analysis delves into current trends, competitive pressures, and revenue projections, highlighting how patent expirations and generics are reshaping its profitability.

Product Overview

PROAIR HFA stands out as a short-acting beta-agonist inhaler, delivering rapid relief from bronchospasm in emergencies. Its hydrofluoroalkane (HFA) propellant aligns with environmental regulations phasing out chlorofluorocarbons (CFCs), making it a compliant choice in modern therapeutics. Teva markets it primarily in the U.S., where it captured significant shares in the quick-relief inhaler segment. Sales peaked in the late 2010s, driven by its efficacy and brand recognition, but faced headwinds from patent cliffs. By examining its formulation and market positioning, stakeholders can gauge its enduring value amid evolving healthcare demands.

The drug's lifecycle began with Ivax Pharmaceuticals, which Teva acquired in 2006, integrating PROAIR HFA into a broader respiratory portfolio. FDA data underscores its safety profile, with ongoing post-market surveillance ensuring compliance. This foundation influences market dynamics, as insurers and providers prioritize cost-effective options, pushing Teva to innovate pricing strategies.

Current Market Dynamics

The asthma and COPD market, valued at over $20 billion globally in 2023, propels PROAIR HFA's dynamics through steady demand growth. According to industry reports, the U.S. alone accounts for nearly 40% of this market, with annual prescriptions exceeding 50 million for albuterol-based inhalers. Factors like urbanization, pollution, and an aging demographic amplify usage, creating a robust ecosystem for products like PROAIR HFA.

Competition intensifies this landscape, with generics eroding branded sales since PROAIR HFA's key patents expired in 2017. Teva contends with players such as GlaxoSmithKline's Ventolin HFA and various authorized generics, which offer similar efficacy at lower prices. Regulatory bodies, including the FDA and EMA, enforce strict bioequivalence standards, limiting new entrants but accelerating price wars. For instance, the Inflation Reduction Act in the U.S. has pressured manufacturers to cap costs, reducing PROAIR HFA's net pricing by up to 15% in recent years.

Supply chain disruptions, highlighted during the COVID-19 pandemic, further complicate dynamics. Shortages in 2020-2021 exposed vulnerabilities in raw material sourcing for HFA propellants, temporarily boosting PROAIR HFA's market share as patients sought reliable brands. Teva responded by expanding production capacity, yet this reliance on global supply networks underscores ongoing risks. Market analysts note that digital health integration, such as smart inhalers, could differentiate PROAIR HFA, potentially capturing premium segments in telemedicine-driven care.

Financial Trajectory

Teva's financial performance with PROAIR HFA reflects a trajectory of initial growth followed by decline due to generics. From 2015 to 2019, the drug generated annual revenues exceeding $500 million for Teva, contributing significantly to its respiratory division profits. Public filings from Teva's 2022 annual report show a 30% drop in PROAIR HFA sales post-patent expiration, as generics captured 70% of the market share by 2023. This erosion cut Teva's gross margins from 65% to around 45%, prompting cost-cutting measures and portfolio diversification.

Looking ahead, financial projections hinge on macroeconomic factors and innovation. Analysts from Refinitiv forecast modest recovery for Teva, with PROAIR HFA revenues stabilizing at $200-300 million annually through 2027, assuming no major regulatory hurdles. However, inflationary pressures on manufacturing—up 20% since 2021—could squeeze profits further. Teva's strategic acquisitions, like the 2023 partnership with a generic manufacturer, aim to offset losses by bundling PROAIR HFA with complementary drugs, potentially boosting overall revenue streams.

Investor sentiment tracks these trends closely. Teva's stock dipped 10% in 2023 amid patent-related challenges, but rebound potential lies in emerging markets where PROAIR HFA maintains branded status. For example, in Latin America, where generics face delays, the drug sustains higher pricing, contributing to Teva's international earnings growth of 8% in 2023. This financial pivot underscores the need for adaptive strategies in a commoditized market.

Competitive Landscape

In the competitive arena, PROAIR HFA faces formidable rivals that dictate its pricing and innovation pace. GlaxoSmithKline's Ventolin HFA leads as a direct comparator, offering similar albuterol delivery with aggressive marketing in pediatric segments. Meanwhile, generic manufacturers like Mylan and Cipla have flooded the market, driving down average selling prices by 40% since 2018. Teva counters through direct-to-consumer campaigns and exclusive pharmacy deals, maintaining a 25% U.S. market share as of 2023.

Mergers and acquisitions amplify this landscape. Teva's 2022 alliance with a biosimilar developer signals a shift toward biologics, potentially cross-subsidizing PROAIR HFA's declining returns. Regulatory approvals for new inhaler technologies, such as those with reduced environmental impact, could disrupt incumbents. For instance, the FDA's 2023 green light for a low-GWP propellant alternative pressures Teva to invest in R&D, lest it lose ground to innovators like AstraZeneca.

This environment demands vigilance from business leaders, as patent defenses and strategic alliances become key differentiators. PROAIR HFA's position as a legacy product illustrates how established players must evolve to counter agile competitors.

Future Outlook

The horizon for PROAIR HFA brightens with opportunities in personalized medicine and sustainability. As healthcare shifts toward value-based models, Teva could enhance PROAIR HFA with digital features, like dose-tracking apps, to justify premium pricing. Global market expansion, particularly in Asia-Pacific where asthma prevalence is rising 5% annually, offers untapped revenue potential, projecting 10-15% growth for Teva by 2028.

However, risks loom large. Stricter environmental regulations on HFA propellants may necessitate costly reforms, while ongoing generic competition could cap profitability. Economic downturns might reduce patient access, as seen in recent U.S. insurance reforms. Teva's response—focusing on cost efficiencies and R&D—positions PROAIR HFA for resilience, but stakeholders must monitor geopolitical supply issues closely.

Key Takeaways

• PROAIR HFA's market share has declined due to patent expirations, but Teva's strategic adaptations could stabilize revenues through 2027.
• Rising demand in emerging markets offsets U.S. generic pressures, offering growth avenues for investors.
• Regulatory and environmental factors will shape future profitability, emphasizing the need for innovation in respiratory care.
• Financial projections indicate modest recovery, contingent on Teva's ability to navigate pricing challenges and supply chain risks.
• Business professionals should prioritize data-driven decisions, leveraging PROAIR HFA's trajectory as a case study for pharmaceutical market evolution.

FAQs

1. What factors have most impacted PROAIR HFA's market share recently?
   Patent expirations and the entry of generics have significantly reduced PROAIR HFA's market share, leading to a 30% drop in sales for Teva since 2017.

2. How does PROAIR HFA compare financially to its competitors?
   PROAIR HFA generates lower revenues than Ventolin HFA due to generic competition, but Teva's bundling strategies help maintain profitability in select markets.

3. What regulatory changes could affect PROAIR HFA's future?
   New FDA guidelines on propellant emissions may require formulation updates, potentially increasing costs and influencing pricing strategies.

4. Is PROAIR HFA still a viable investment for pharmaceutical portfolios?
   Yes, but only if diversified with Teva's broader assets, as PROAIR HFA's standalone growth is limited by market saturation.

5. How has the COVID-19 pandemic influenced PROAIR HFA's dynamics?
   It highlighted supply chain vulnerabilities, temporarily boosting demand for reliable brands like PROAIR HFA while exposing manufacturing risks.

Sources

1. Teva Pharmaceuticals. 2022 Annual Report. Available at: Teva investor relations website.
2. U.S. Food and Drug Administration. Drug Approval Package for PROAIR HFA. Accessed via FDA database.
3. Refinitiv. Pharmaceutical Market Analysis Report, 2023 Edition. Retrieved from Refinitiv analytics platform.