ATROVENT HFA Drug Patent Profile

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

Atrovent Hfa is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in ATROVENT HFA is ipratropium bromide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atrovent Hfa

A generic version of ATROVENT HFA was approved as ipratropium bromide by RITEDOSE CORP on January 26^th, 2001.

Summary for ATROVENT HFA

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	47
Patent Applications:	4,700
Drug Prices:	Drug price information for ATROVENT HFA
DailyMed Link:	ATROVENT HFA at DailyMed

See drug prices for ATROVENT HFA

See drug sales revenues for ATROVENT HFA

Recent Clinical Trials for ATROVENT HFA

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

Sponsor	Phase
Hat Yai Medical Education Center	Phase 3
Ohio State University	Phase 4
Nationwide Children's Hospital	Phase 4

See all ATROVENT HFA clinical trials

Pharmacology for ATROVENT HFA

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for ATROVENT HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATROVENT HFA	Inhalation Aerosol	ipratropium bromide	0.21 mg/Inh	021527	1	2023-12-29

US Patents and Regulatory Information for ATROVENT HFA

ATROVENT HFA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004		RX	Yes	Yes	8,474,447		Y		Y

Expired US Patents for ATROVENT HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	6,739,333
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	5,676,930
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	6,983,743
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	5,766,573

International Patents for ATROVENT HFA

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2126248	LIQUID PHARMACEUTICAL COMPOSITION AS AN AEROSOL
Japan	4048027
Germany	102007045438	Inhalier-Gerät
Finland	114283

Market Dynamics and Financial Trajectory for ATROVENT HFA

Last updated: November 4, 2025

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Introduction

ATROVENT HFA (ipratropium bromide inhalation aerosol) stands as a pivotal bronchodilator in the management of chronic obstructive pulmonary disease (COPD) and asthma. As a successor to the traditional nebulized formulations, ATROVENT HFA introduces metered-dose inhaler (MDI) delivery, aligning with evolving respiratory treatment paradigms. This analysis explores the market drivers, competitive landscape, regulatory influences, and financial prospects shaping the trajectory of ATROVENT HFA.

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Market Overview and Demand Drivers

The global COPD therapeutics market surpasses USD 15 billion and exhibits persistent growth, driven by rising smoking prevalence, aging populations, and increasing awareness of respiratory diseases [1]. Asthma treatment similarly fuels demand, with the global market projected to grow at a CAGR exceeding 4% through 2028 [2].

ATROVENT HFA's core appeal lies in its targeted delivery mechanism, offering rapid onset, portability, and user-friendly inhalation. Its positioning as an established bronchodilator with a long-standing clinical track record sustains demand amid a competitive landscape.

Key demand drivers include:

• Aging Population: The elderly, disproportionately affected by COPD, maintain robust utilization rates.
• Brand Loyalty & Prescriber Preference: Long-term clinical familiarity sustains prescribing patterns.
• Regulatory Support: Approval pathways favor proven delivery systems, bolstering market access.
• Product Differentiation: With the inhaler market transitioning towards digital and multi-drug combinations, ATROVENT HFA retains relevance as a standalone treatment and a component of combination therapies.

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Competitive Landscape

The respiratory device and drug markets are intensely competitive, featuring direct counterparts such as albuterol MDIs and other ipratropium formulations. Notable competitors include:

• Respimat-based Ipratropium: Offering alternative inhalation devices.
• Combination products: Such as DuoNeb (albuterol-ipratropium nebulizer solution) and other multidrug inhalers, which deliver enhanced therapeutic synergy.
• Emerging Biologics and Novel Drugs: Including monoclonal antibodies for severe COPD, though these target different patient subsets.

Key competitive features influencing ATROVENT HFA's positioning include device efficacy, patient adherence, drug pricing, reimbursement policies, and insurance coverage.

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Regulatory and Patent Landscape

ATROVENT HFA benefits from a well-established regulatory profile, initially approved by the FDA in the early 2000s. Patent protections surrounding its formulation and delivery device have historically shielded its market share, though patent expirations for similar products have spurred generic entries.

Recent regulatory trends favoring digital inhalers and personalized medicine could influence future positioning. However, as a mature product, ATROVENT HFA's future growth depends largely on lifecycle management strategies, including line extensions, combination therapies, and formulary negotiations.

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Financial Trajectory and Revenue Projections

Contributing significantly to its manufacturer’s portfolio, ATROVENT HFA's revenue relies on demand stability, competitive pricing, and market access strategies.

• Historical Performance: Past sales reflect a mature drug with steady but slowing growth; in 2021, annual global sales approached USD 500 million, primarily in North America and Europe [3].
• Growth Opportunities: Introduction in new markets, increased adoption in emerging economies, and expansion into related therapeutic areas (e.g., pediatric asthma) can catalyze revenue streams.
• Pricing Dynamics: The shift toward value-based care and increasing pressure on drug pricing pose challenges, necessitating strategic pricing models and reimbursement negotiations.
• Lifecycle Management: Developing combination inhalers incorporating ATROVENT HFA or reformulating into dry powder inhalers (DPIs) may unlock additional sales, prolonging product relevance.

Forecasts suggest that, barring significant patent challenges, ATROVENT HFA's revenues could remain within the USD 400-600 million range for the next 3-5 years, with potential growth if market expansion and new formulations are successfully introduced.

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Market Challenges and Risks

Several factors could hinder growth trajectories:

• Generic Competition: Patent cliffs could herald generics that erode market share.
• Regulatory Changes: Evolving approval standards for inhaler devices and formulations may necessitate costly modifications.
• Technological Advancements: Adoption of digital inhalers providing real-time adherence monitoring could favor newer products.
• Pricing Pressures: Healthcare reforms aimed at reducing drug costs increasingly impact profitability.

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Strategic Opportunities

To maximize financial prospects, stakeholders should prioritize:

• Product Innovation: Developing digital inhalers with connectivity features.
• Combination Formulations: Merging ATROVENT HFA with long-acting bronchodilators or corticosteroids.
• Market Expansion: Targeting emerging markets with aging demographics and expanding indications.
• Lifecycle Extensions: Securing patents or exclusivity for formulations and delivery devices.

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Conclusion

ATROVENT HFA remains a commercially relevant bronchodilator in the respiratory therapeutics landscape, underpinned by a stable demand base and a mature market. Its financial trajectory hinges on strategic lifecycle management, technological adaptation, and market penetration. As competition intensifies and regulatory environments evolve, proactive innovation and cost positioning will be vital in sustaining its market share and optimizing revenue.

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Key Takeaways

• Stable Demand: ATROVENT HFA's longstanding clinical utility ensures consistent therapy adoption among COPD and asthma patients.
• Competitive Pressures: Patents, generics, and innovative inhalers pose challenges; strategic differentiation is critical.
• Growth Prospects: Expansion into emerging markets and new formulations represent key opportunities.
• Regulatory and Pricing Risks: Evolving policies necessitate agility in compliance and reimbursement strategies.
• Innovation as a Differentiator: Digital inhalers and combination therapies can extend product lifecycle and enhance financial performance.

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FAQs

1. What are the primary market drivers for ATROVENT HFA?
Demand is driven by the increasing prevalence of COPD and asthma, aging populations, prescriber familiarity, and the drug’s proven clinical efficacy.

2. How does patent expiration affect ATROVENT HFA’s market position?
Patent expirations open doors for generic competition, potentially reducing prices and sales unless lifecycle management strategies, like reformulations or new device features, are employed.

3. What competitive advantages does ATROVENT HFA possess?
Its longstanding clinical track record, established safety profile, and device familiarity confer an advantage amid evolving inhaler technologies.

4. How is technological innovation impacting ATROVENT HFA’s financial outlook?
Advancements such as digital inhalers enhance adherence tracking and personalized therapy, but also introduce new competitors. Staying current through innovation is vital for maintaining market relevance.

5. What strategic moves could enhance ATROVENT HFA’s future revenue?
Developing combination products, expanding into emerging markets, investing in digital inhaler features, and leveraging lifecycle management can boost longevity and profitability.

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Sources

1. Grand View Research. "Chronic Obstructive Pulmonary Disease (COPD) Diagnostics and Therapeutics Market Size, Share & Trends Analysis Report." 2022.
2. Research and Markets. "Global Asthma Drugs Market Forecast to 2028." 2022.
3. IQVIA. "Pharmaceutical Market Reports." 2022.