ATROVENT Drug Patent Profile

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

Atrovent is a drug marketed by Boehringer Ingelheim and is included in five NDAs. There is one patent protecting this drug.

The generic ingredient in ATROVENT 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

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

Summary for ATROVENT

US Patents:	0
Applicants:	1
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	47
Patent Applications:	7,886
Drug Prices:	Drug price information for ATROVENT
What excipients (inactive ingredients) are in ATROVENT?	ATROVENT excipients list
DailyMed Link:	ATROVENT at DailyMed

See drug prices for ATROVENT

Recent Clinical Trials for ATROVENT

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 clinical trials

US Patents and Regulatory Information for ATROVENT

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	ipratropium bromide	AEROSOL, METERED;INHALATION	019085-001	Dec 29, 1986		DISCN	No	No
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020394-001	Oct 20, 1995		DISCN	Yes	No
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SOLUTION;INHALATION	020228-001	Sep 29, 1993		DISCN	Yes	No
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020393-001	Oct 20, 1995		DISCN	Yes	No

Expired US Patents for ATROVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	ATROVENT	ipratropium bromide	AEROSOL, METERED;INHALATION	019085-001	Dec 29, 1986
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020394-001	Oct 20, 1995
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020393-001	Oct 20, 1995

International Patents for ATROVENT

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

Country	Patent Number	Title	Estimated Expiration
Germany	2903957
South Africa	7008400
Belgium	760251
Australia	4865079

Market Dynamics and Financial Trajectory for ATROVENT (Ipratropium Bromide)

Last updated: July 31, 2025

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Introduction

ATROVENT, a branded inhaler containing Ipratropium Bromide, has remained a cornerstone in the treatment of respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD) and asthma since its introduction. Understanding its market dynamics and financial trajectory provides insights into its positioning within the pharmaceutical landscape, competitive pressures, and future potential.

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Market Overview

Global Respiratory Disease Burden

Respiratory diseases influence hundreds of millions globally, with COPD ranking as the third leading cause of death worldwide ([1]). The expanding prevalence of COPD and asthma has driven demand for effective bronchodilators like ATROVENT. The World Health Organization (WHO) estimates COPD affects more than 200 million people, with a rising trend driven by aging populations and environmental pollutants ([2]).

Market Segmentation

The inhaled respiratory drug market is segmented into:

• Short-acting muscarinic antagonists (SAMAs): Includes ATROVENT.
• Long-acting muscarinic antagonists (LAMAs)
• Beta-agonists
• Combination therapies

ATROVENT's primary role is as a SAMA, often used for acute episodes and as part of combination therapy. Its segment is influenced by clinical guidelines advocating for early intervention and combination therapy efficacy.

Competitive Landscape

ATROVENT faces competition from:

• LAMA and LABA/LAMA combo inhalers (e.g., Spiriva, Ultibro)
• Leukotriene receptor antagonists and inhaled corticosteroids

While newer fixed-dose combinations threaten to diminish ATROVENT’s market share, its established efficacy and safety profile sustain its relevance, especially in certain markets and critical care settings.

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Market Dynamics

Regulatory Factors

Regulatory policies influence ATROVENT’s market trajectory. Patent expirations of key formulations in the late 1990s and early 2000s facilitated generic entry, leading to significant price erosion. Nonetheless, branded versions, especially in emerging markets, retain substantial market share due to perceived quality and supplier relationships.

Price and Reimbursement Trends

Pricing pressures stem from increased generic competition and national health schemes aiming to reduce costs. In many regions, inclusion in insurance formularies and reimbursement policies continue to support steady sales, although margins diminish comparatively.

Technological Advancements

Delivery devices have evolved, with inhalers becoming more portable and user-friendly. While this affects the competitive landscape, ATROVENT’s traditional metered-dose inhalers (MDIs) retain favor in acute and hospital settings.

Emergence of Biosimilars and Generics

Generic versions of Ipratropium Bromide have flooded markets, notably in Europe and Asia, delivering cost advantages but often limited clinical differentiation. This trend pressures branded formulations’ pricing strategies and market shares.

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Financial Trajectory

Historical Revenue Trends

Historically, ATROVENT generated hundreds of millions in annual sales globally, primarily through its inhaler formulations. Its revenue trajectory experienced declines post-patent expiry due to generic competition; however, steady demand persists in specific markets, especially in regions with limited access to newer drugs.

Regional Market Performance

• United States & Europe: Market share has declined owing to the adoption of LAMA/ICS combinations; however, ATROVENT remains a viable option for certain patient populations.
• Emerging Markets: Growth remains robust due to affordability, availability, and clinical familiarity. Countries like India, Brazil, and China report consistent demand, driven by high COPD prevalence.

Profitability and Margins

Generic competition has resulted in compression of profit margins. However, manufacturing efficiencies, cost-saving measures, and strategic partnerships have helped sustain profitability. Additionally, some pharmaceutical companies maintain niche markets through licensed formulations and specialized delivery systems.

Future Revenue Outlook

The future of ATROVENT’s revenue hinges on:

• Regulatory landscape in key markets
• Development and marketing of combination therapies
• Pricing strategies and reimbursement policies
• Potential new formulations or delivery innovations

In the short to medium term, revenues are expected to stabilize or slightly decline, given the saturation in mature markets and shift toward newer therapies.

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Strategic Factors Influencing Future Trajectory

• Pipeline Innovations: Companies are exploring inhaler device improvements and combination formulations that could reduce the prominence of traditional ATROVENT inhalers.

• Market Penetration in Developing Countries: Increased access and affordability could sustain or increase demand, supporting revenue streams.

• Regulatory Approvals for Biosimilars: Entry of biosimilars might further impact pricing and market share.

• Healthcare Policy Shifts: Emphasis on cost-effective treatments may favor generic versions, pushing branded drugs like ATROVENT towards niche or adjunctive roles.

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Conclusion

The market for ATROVENT remains influenced by a confluence of regulatory, technological, and competitive factors. While face pressures from generics and newer therapies, it sustains presence through established efficacy, diverse global markets, and clinical familiarity. The financial trajectory suggests a plateau with potential for stabilization in mature markets, alongside growth opportunities in developing economies where affordability and access remain pivotal.

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Key Takeaways

• Market driven by COPD and asthma prevalence: The growing disease burden sustains demand, especially in emerging markets.
• Generic competition and pricing pressures dominate: These factors have eroded margins but preserved demand in cost-sensitive regions.
• Shifts toward combination therapies: Newer inhalers threaten traditional ATROVENT formulations, influencing future revenue.
• Innovation in delivery systems: Advances may extend product relevance or open new markets.
• Strategic focus on emerging markets: Opportunities persist through affordability and healthcare infrastructure expansion.

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FAQs

1. How does ATROVENT compare to newer bronchodilators in terms of efficacy?
ATROVENT remains effective for acute symptom relief and as part of combination therapy but is generally surpassed by long-acting agents for maintenance. Its role is more adjunctive or in specific patient subsets.

2. What are the main drivers of generic competition against ATROVENT?
Patents expired in key markets facilitated the entry of cost-effective generics, driven by manufacturing advancements and regulatory approvals. Price competition and formulary preferences further accelerate displacement.

3. Are biosimilars affecting ATROVENT’s market share?
While biosimilars are more relevant for biologic therapies, the emergence of generic small-molecule inhalers like Ipratropium Bromide impacts ATROVENT’s pricing and sales.

4. What opportunities exist for ATROVENT in emerging markets?
High COPD prevalence, limited access to newer therapies, and price sensitivity create opportunities to maintain or grow revenue, especially with local manufacturing and tailored distribution strategies.

5. How might regulatory changes influence ATROVENT’s future?
Strict cost-containment policies and reimbursement adjustments could further favor generics, reducing branded product sales. Conversely, approval of innovative formulations could provide new growth avenues.

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References:

[1] World Health Organization. (2021). The global burden of respiratory diseases.
[2] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2022). Global Strategy for Prevention, Diagnosis and Management of COPD.