Ipratropium bromide - Generic Drug Details

What are the generic drug sources for ipratropium bromide and what is the scope of patent protection?

Ipratropium bromide is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Pharmobedient, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, Hikma, Lupin, and Rubicon Research, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ipratropium bromide has ten patent family members in nine countries.

There are eight drug master file entries for ipratropium bromide. Twenty-one suppliers are listed for this compound.

Summary for ipratropium bromide

International Patents:	10
US Patents:	1
Tradenames:	3
Applicants:	19
NDAs:	32
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	90
What excipients (inactive ingredients) are in ipratropium bromide?	ipratropium bromide excipients list
DailyMed Link:	ipratropium bromide at DailyMed

See drug sales revenues for ipratropium bromide

Recent Clinical Trials for ipratropium bromide

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

Sponsor	Phase
Assiut University	PHASE3
Dr. J. Alberto Neder	PHASE4
Damanhour University	PHASE1

See all ipratropium bromide clinical trials

Pharmacology for ipratropium bromide

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for ipratropium bromide

Bronchodilator Agents

Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ipratropium bromide

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

R01AX	Other nasal preparations
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for IPRATROPIUM BROMIDE

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 ipratropium bromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	215105-001	Aug 16, 2022	AB	RX	No	No
Lupin	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	217886-001	Jan 27, 2025	AB	RX	No	No
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020393-001	Oct 20, 1995		DISCN	Yes	No
Bausch	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	076103-001	Mar 31, 2003	AB	RX	No	No
Boehringer Ingelheim	ATROVENT	ipratropium bromide	AEROSOL, METERED;INHALATION	019085-001	Dec 29, 1986		DISCN	No	No

Expired US Patents for ipratropium bromide

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
Boehringer Ingelheim	ATROVENT	ipratropium bromide	AEROSOL, METERED;INHALATION	019085-001	Dec 29, 1986
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020393-001	Oct 20, 1995
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020394-001	Oct 20, 1995
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004

International Patents for ipratropium bromide

Country	Patent Number	Title	Estimated Expiration
Canada	2700201	INHALATEUR (INHALER DEVICE)
Japan	2010538780
World Intellectual Property Organization (WIPO)	2009037085
Poland	2203205
Denmark	2203205

Last updated: September 24, 2025

rket Dynamics and Financial Trajectory for Ipratropium Bromide

Introduction

Ipratropium bromide, a bronchodilator primarily used in the management of obstructive airway conditions such as chronic obstructive pulmonary disease (COPD) and asthma, continues to hold a significant position within respiratory therapy. As a non-selective muscarinic antagonist, its role in inhaler formulations remains crucial for patients requiring personalized, immediate relief. This analysis explores the market drivers, competitive landscape, regulatory considerations, and financial prospects shaping the trajectory of ipratropium bromide in the current healthcare ecosystem.

Market Overview and Current Landscape

Globally, the demand for respiratory drugs, including ipratropium bromide, is driven by increasing prevalence rates of COPD and asthma. According to the World Health Organization (WHO), COPD is the third leading cause of death worldwide, with over 200 million cases documented globally [1]. The rising burden of respiratory diseases amplifies the need for effective bronchodilator therapies, thus supporting consistent market demand for ipratropium bromide.

Major pharmaceutical players, such as Boehringer Ingelheim, Mylan, and Teva Pharmaceuticals, dominate the inhaled anticholinergic segment, offering various formulations including nebulizer solutions and metered-dose inhalers (MDIs). These formulations benefit from established manufacturing processes and a wide existing patient base, ensuring steady revenue streams.

Market Drivers

1. Growing Prevalence of Respiratory Conditions
   The escalation in COPD and asthma incidences directly impacts ipratropium bromide demand. Aging populations and increased tobacco consumption contribute significantly to these trends, especially in emerging economies where healthcare infrastructure is improving.

2. Evolving Treatment Guidelines
   Leading respiratory societies, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the Global Initiative for Asthma (GINA), endorse the use of anticholinergic agents like ipratropium bromide as first-line or adjunct therapy, reinforcing its clinical relevance [2].

3. Product Portfolio Expansion and Formulation Innovation
   Advancements in inhaler technology and combination therapies incorporating ipratropium bromide enhance treatment efficacy and patient compliance. Such innovations maintain the drug's relevance amidst competition.

4. Patent Expiry and Generic Entry
   The expiration of key patents facilitates increased generic manufacturing, leading to price reductions and broader accessibility. Particularly in low- and middle-income countries, lower-cost generics significantly expand the market base.

Competitive and Regulatory Landscape

The competitive environment is characterized by a mix of branded and generic products. Patents on certain formulations have expired or are nearing expiry, opening avenues for generic manufacturers to penetrate markets with cost-effective options [3]. Regulatory pathways differ across regions but generally include stringent proof of bioequivalence and safety.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have streamlined approval pathways for generic inhalers, potentially accelerating market penetration for new entrants. However, inhalation device registration involves complex bioequivalence testing, which can pose barriers to smaller companies.

Market Challenges and Risks

• Market Saturation and Pricing Pressures: The availability of generics results in aggressive pricing strategies, compressing profit margins for originators.
• Regulatory Hurdles: Variations in inhaler device approval requirements can delay product launches.
• Competition from Alternative Therapies: Long-acting muscarinic antagonists (LAMAs) and combination inhalers (e.g., tiotropium/olodaterol) offer competing treatment options, potentially impacting market share.
• Innovation Barriers: The need for continuous innovation in inhaler design and drug delivery mechanisms incurs high R&D costs.

Financial Trajectory and Future Outlook

The global respiratory drug market, including ipratropium bromide, was valued at approximately USD 17 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2028 [4]. Ipratropium bromide’s segment specifically benefits from its position as a cost-effective, established therapy, especially in markets with limited access to newer biologic treatments.

Emerging markets are anticipated to display the fastest growth, driven by increasing healthcare access, improved diagnostic rates, and expanding insurance coverage. For example, Asia-Pacific is expected to witness a CAGR exceeding 7%, nurturing opportunities for both generic manufacturers and established firms seeking regional expansion.

In terms of revenue, the segment's outlook remains favorable as the drug maintains a foundational role in respiratory therapy. While patent cliffs for certain formulations may create short-term volatility, the overall financial trajectory is bolstered by the increasing demand for affordable inhaler solutions.

Strategic Opportunities

• Development of Fixed-dose Combinations (FDCs): Combining ipratropium bromide with agents like albuterol can improve patient outcomes, offering a competitive edge.
• Device Innovation: Improving inhaler design for ease of use and dose delivery accuracy can enhance market share.
• Market Expansion: Targeting low-income and developing regions with affordable generic products aligns with increasing healthcare infrastructure and rising respiratory disease prevalence.
• Regulatory Engagement: Proactively managing approval pathways and demonstrating bioequivalence can accelerate market entry for new formulations.

Conclusion

Ipratropium bromide remains a vital component of respiratory pharmacotherapy, supported by robust market drivers including rising disease burden and favorable regulatory shifts. The impending expirations of key patents and the proliferation of generics will reshape competitive dynamics, creating both opportunities and challenges. Companies that innovate in device design, expand into emerging markets, and develop combination therapies will be best positioned to capitalize on its ongoing financial trajectory.

Key Takeaways

• The global demand for ipratropium bromide is projected to grow steadily due to increasing respiratory disease prevalence.
• Patent expiries promote a surge in generic formulations, driving down prices and expanding access, particularly in emerging markets.
• Innovation in inhaler technology and combination therapies offers competitive advantages.
• Market growth is concentrated in developing regions, necessitating tailored regulatory and marketing strategies.
• Companies should monitor evolving regulatory landscapes and focus on cost-effective, patient-friendly formulations to sustain revenue streams.

FAQs

1. What factors influence the pricing of ipratropium bromide?
Pricing is affected by patent status, manufacturing costs, regulatory requirements, competition from generics, and regional healthcare policies. Patent expiries generally lead to price reductions and increased market access.

2. How does patent expiration impact the market for ipratropium bromide?
Patent expirations facilitate the entry of generic manufacturers, increasing competition, lowering prices, and expanding accessibility. This often results in a shift from branded to generic products, affecting original drug revenues.

3. What are the primary competitors to ipratropium bromide in respiratory therapy?
The main competitors include other inhaled bronchodilators such as long-acting muscarinic antagonists (e.g., tiotropium), beta-agonists (e.g., salbutamol), and combination therapies that integrate multiple drug classes.

4. What regions are expected to see the highest growth in ipratropium bromide demand?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa are projected to experience significant growth due to rising respiratory disease prevalence and expanding healthcare infrastructure.

5. What innovations could influence the future market of ipratropium bromide?
Innovations include advanced inhaler devices with improved delivery and ease of use, fixed-dose combination inhalers, and formulations with enhanced drug stability or reduced side effects.