PROVENTIL-HFA Drug Patent Profile

Which patents cover Proventil-hfa, and when can generic versions of Proventil-hfa launch?

Proventil-hfa is a drug marketed by Kindeva and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proventil-hfa

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

Summary for PROVENTIL-HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	19
Patent Applications:	5,216
DailyMed Link:	PROVENTIL-HFA at DailyMed

Recent Clinical Trials for PROVENTIL-HFA

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

Sponsor	Phase
AstraZeneca	Phase 2
University Medical Center of Southern Nevada	N/A
Asthma Management Systems	Phase 4

See all PROVENTIL-HFA clinical trials

Paragraph IV (Patent) Challenges for PROVENTIL-HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROVENTIL-HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	020503	1	2015-05-20

US Patents and Regulatory Information for PROVENTIL-HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	AB1	RX	Yes	Yes

Expired US Patents for PROVENTIL-HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996

International Patents for PROVENTIL-HFA

See the table below for patents covering PROVENTIL-HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H08509689
Germany	68904300
European Patent Office	0995434
European Patent Office	0796805	Configuration de joint d'étanchéité pour récipient aérosol (Seal configuration for aerosol canister)
World Intellectual Property Organization (WIPO)	9425373
Japan	H02200627	MEDICAL AEROSOL PREPARATION

Market Dynamics and Financial Trajectory for PROVENTIL-HFA

Last updated: July 29, 2025

Introduction

PROVENTIL-HFA (albuterol sulfate inhalation aerosol) stands as a cornerstone in bronchodilator therapy, predominantly prescribed for asthma and chronic obstructive pulmonary disease (COPD). As a vital inhaler medication, its market trajectory hinges on a complex interplay of regulatory, competitive, and technological shifts. This report delineates the evolving market dynamics and forecasts the financial trajectory for PROVENTIL-HFA, providing stakeholders with comprehensive insights essential for strategic decision-making.

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1. Market Overview

1.1 Product Profile and Therapeutic Role

PROVENTIL-HFA contains albuterol sulfate, a selective β2-adrenergic agonist that induces bronchial smooth muscle relaxation, providing rapid relief from acute bronchospasm. Its inhalation aerosol formulation revolutionized delivery, making it a preferred treatment for both asthma attacks and COPD exacerbations.

1.2 Market Size and Segmentation

The global asthma therapeutics market was valued at approximately USD 26 billion in 2022, with inhaled bronchodilators accounting for over 55% of this figure [1]. PROVENTIL-HFA holds a significant market share within the short-acting β2-agonists (SABAs) segment, especially in North America and Europe.

The COPD segment, projected to grow at a CAGR of 4.7% through 2030, further expands the scope for albuterol-based inhalers [2].

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2. Key Market Drivers

2.1 Rising Prevalence of Respiratory Conditions

The World Health Organization reports over 262 million asthma cases globally [3], and COPD affects an estimated 200 million people. The increasing burden of respiratory diseases, fueled by urbanization and environmental pollution, drives demand for effective bronchodilators, including PROVENTIL-HFA.

2.2 Advancements in Inhaler Technology

Innovations in inhaler devices—such as breath-actuated inhalers and multidose reservoirs—enhance patient adherence and therapy outcomes, sustaining the demand for existing formulations like PROVENTIL-HFA.

2.3 Regulatory Environment and Patent Landscape

While PROVENTIL-HFA’s patent protections have largely expired, leading to generic competition, regulatory frameworks emphasizing fast-track approvals for generic inhalers bolster accessibility and market penetration [4].

2.4 Global Accessibility and Distribution

Expansion in emerging markets, supported by health initiatives and international procurement contracts, continues to open new revenue streams for PROVENTIL-HFA, especially as affordability improves.

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3. Competitive Landscape

3.1 Generic Competition and Market Saturation

Post-patent expiry, generic versions of albuterol inhalers flooded the market, exerting downward pressure on prices. In the U.S., multiple FDA-approved generics have captured a significant share, reducing revenue per unit but expanding overall volume sales.

3.2 Brand vs. Generic Dynamics

Brands like PROVENTIL-HFA benefit from existing brand recognition, physician preference, and patient familiarity. However, generic price competitiveness forces innovator companies to adopt strategic pricing and marketing approaches to maintain margins.

3.3 Emerging Alternatives

Long-acting β2-agonists (LABAs) and combination inhalers (e.g., LABA/ICS) are increasingly replacing SABAs for maintenance therapy, potentially affecting PROVENTIL-HFA’s role as a rescue inhaler.

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4. Regulatory and Reimbursement Trends

4.1 Evolving Reimbursement Policies

Insurance companies and government programs are increasingly scrutinizing inhaler costs. Value-based reimbursement models incentivize the use of cost-effective generics, influencing profit margins for branded products like PROVENTIL-HFA.

4.2 Environmental Concerns and Inhaler Regulations

The push to replace hydrofluoroalkane (HFA) propellants, relating to ozone depletion, prompts formulation changes and the development of environmentally friendly inhalers, potentially impacting existing products.

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5. Financial Trajectory Forecast

5.1 Short-Term Outlook (1-3 Years)

In the immediate term, revenues for PROVENTIL-HFA are expected to decline modestly due to intensified generic competition and pricing pressures. However, steady demand driven by existing patient bases and ongoing market expansion in underserved regions will sustain revenues.

5.2 Medium to Long-Term Outlook (3-10 Years)

Projections indicate a gradual decline in branded inhaler sales unless strategized innovations are introduced. Opportunities include:

• Line extensions: Developing combination therapies or alternative formulations.
• Regulatory approvals: Gaining clearance for new delivery devices.
• Market expansion: Penetrating emerging markets with tailored distribution strategies.

Despite these opportunities, the fundamental trend suggests a plateauing or marginal decline in PROVENTIL-HFA’s revenues by 2028, aligning with the general lifecycle of inhaler products post-patent expiration.

5.3 Impact of Biotech and Device Innovation

Emerging biotech therapies and digital inhalers with sensors may redefine the therapeutic landscape, potentially displacing traditional β2-agonist inhalers.

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6. Strategic Implications

6.1 Diversification and Portfolio Expansion

Manufacturers should explore pipeline products and combination therapies to offset declines. Investing in next-generation delivery devices also offers differentiation.

6.2 Pricing and Market Access Strategies

Aggressive pricing, coupled with patient assistance programs and formulary negotiations, will be critical to maintain market share.

6.3 Focus on Emerging Markets

Expanding distribution channels in Asia, Africa, and Latin America can offset stagnation in mature markets. Tailored formulations and pricing strategies are vital in these regions.

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7. Conclusion

The market dynamics for PROVENTIL-HFA are characterized by robust demand driven by respiratory disease prevalence, technological innovation, and expanding global markets. However, patent expiration and fierce competition from generics pressurized margins, compelling manufacturers to invest in innovation, diversification, and market penetration strategies. The financial trajectory suggests a gradual decline in traditional revenues unless mitigated through product innovation and strategic adaptations.

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Key Takeaways

• Demand stability for PROVENTIL-HFA persists due to the high prevalence of asthma and COPD, especially in emerging markets.
• Generic competition significantly impacts profitability, necessitating strategic pricing and innovation.
• Advances in inhaler technology and alternative therapies pose long-term challenges but also opportunities for product differentiation.
• Market expansion in developing regions remains crucial for revenue sustenance amid declining patent protections.
• Innovation in delivery devices and combination therapies can provide a competitive edge and mitigate revenue decline over the next decade.

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FAQs

1. How will patent expirations influence PROVENTIL-HFA’s market share?
Patent expirations have led to a surge in generic inhalers, increasing competition and reducing brand-specific revenues. Companies must innovate or diversify to retain market share.

2. Are there developments in environmentally friendly inhalers affecting PROVENTIL-HFA?
Yes. Regulatory shifts favor low-GWP (Global Warming Potential) propellants, prompting reformulation and device modifications, which could impact existing products like PROVENTIL-HFA.

3. What role does geographic expansion play in the future of PROVENTIL-HFA?
Significant, especially in regions with rising respiratory disease prevalence and less saturated markets. Tailored affordability and distribution strategies are essential for success.

4. How is the rise of combination inhalers impacting PROVENTIL-HFA?
While combination therapy offers improved adherence, SABAs like PROVENTIL remain critical for rescue use. Market shifts toward long-acting formulations could reduce reliance on short-acting agents.

5. What strategies can manufacturers adopt to prolong PROVENTIL-HFA’s market relevance?
Investing in formulation innovations, device technology, and expanding into emerging markets are key strategies to sustain revenues amidst evolving competitive landscapes.

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References:

[1] GlobalData, “Asthma Therapeutics Market Size & Share Analysis,” 2022.

[2] MarketsandMarkets, “COPD Therapeutics Market Forecast,” 2023.

[3] WHO, “Asthma,” 2022.

[4] FDA, “Regulatory Pathways for Inhalers Post-Patent,” 2022.