IPRATROPIUM BROMIDE - Generic Drug Details

What are the generic sources for ipratropium bromide and what is the scope of freedom to operate?

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
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020394-001	Oct 20, 1995		DISCN	Yes	No
Bausch	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	076103-001	Mar 31, 2003	AB	RX	No	No
Sun Pharm	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	207903-001	Jan 3, 2017		DISCN	No	No
Rubicon Research	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	219221-001	Nov 15, 2024	AB	RX	No	No
Hikma	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	076598-001	Nov 5, 2003	AB	RX	No	Yes
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SOLUTION;INHALATION	020228-001	Sep 29, 1993		DISCN	Yes	No
Rubicon Research	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	219222-001	Jan 14, 2025	AB	RX	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	5,766,573
Boehringer Ingelheim	ATROVENT	ipratropium bromide	AEROSOL, METERED;INHALATION	019085-001	Dec 29, 1986	3,681,500
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020394-001	Oct 20, 1995	4,385,048
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020393-001	Oct 20, 1995	4,385,048
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	5,683,677

International Patents for IPRATROPIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009037085
Germany	102007045438	Inhalier-Gerät
Canada	2700201	INHALATEUR (INHALER DEVICE)
Spain	2539285
Japan	2010538780
Poland	2203205
Japan	5436430

Market Dynamics and Financial Trajectory for Ipratropium Bromide

Last updated: January 15, 2026

Summary
Ipratropium bromide, a short-acting anticholinergic bronchodilator, remains a pivotal therapy for obstructive airway diseases, predominantly chronic obstructive pulmonary disease (COPD) and asthma. Its global market has evolved alongside shifting epidemiological patterns, regulatory landscapes, and technological advances. This report analyzes the market drivers, barriers, competitive landscape, financial prospects, and strategic implications of Ipratropium bromide from 2023 onwards.

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What are the key market drivers for Ipratropium Bromide?

Epidemiological Trends

• Rising prevalence of COPD and asthma:
  The WHO estimates 300 million people suffer from asthma, and over 200 million have COPD globally, projecting a compounded annual growth rate (CAGR) of approximately 4.2% for COPD from 2022–2030[^1].

• Aging populations:
  The demographic shift towards older populations, especially in North America, Europe, and parts of Asia, increases demand, given these groups’ higher disease burden.

Regulatory Environment and Approvals

• Recognition by regulatory authorities:
  Ipratropium bromide’s approval for conditions like COPD has remained stable; however, regulatory encouragement for combination therapies (e.g., with beta-agonists) sharpens growth potential[^2].

Product Portfolio and Innovation

• Formulation advancements:
  Development of inhaler devices with improved delivery efficiency enhances patient adherence and broadens market scope.

• Brand proliferation:
  Numerous generic versions have entered markets post-patent expiry, significantly reducing costs and expanding access.

Healthcare Policy and Reimbursement

• Government and insurance coverage:
  Reimbursement policies favor cost-effective, evidence-based therapies like Ipratropium bromide, especially in developing economies.

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What are the primary barriers impacting market growth?

Patent and Market Competition

• Patent expiration:
  The original patents expired around the early 2000s, leading to a flood of generic and biosimilar products, intensifying price competition[^3].

Availability of Alternatives

• Emerging therapies:
  Long-acting muscarinic antagonists (LAMAs) such as tiotropium now serve as preferred options, reducing Ipratropium’s market share[^4].

• Combination inhalers:
  Fixed-dose combinations (e.g., with formoterol or salmeterol) are increasingly favored for convenience and efficacy.

Pricing and Cost Sensitivity

• Price erosion:
  Competition has driven prices down, particularly in markets with strong generic manufacturing capabilities.

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How does the competitive landscape shape future prospects?

Major Market Participants

Company	Product Name(s)	Key Strategies	Market Share (Est.)
Teva Pharmaceuticals	Atrovent (generic inhaler)	Price competition, distribution expansion	35% (global)
Novartis	Spiriva (LAMA/LABA)	Innovation in combination therapies	25%
Mylan	Ipratropium bromide inhaler (generic)	Price and market penetration	20%
Others	Various generics	Cost leadership	20%

Emerging Trends & Opportunities

• Combination therapies:
  Increasing adoption of fixed-dose inhalers combining Ipratropium with beta-agonists or corticosteroids enhances market appeal—projected to grow at 6% CAGR annually through 2028[^5].

• Emerging markets:
  Countries like India, China, and Brazil exhibit high growth potential due to expanding healthcare infrastructure and rising disease prevalence.

• Device innovation:
  Development of breath-actuated inhalers and smart inhalers tracks usage, improving adherence and clinical outcomes, creating premium segments.

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What are the financial projections for Ipratropium Bromide?

Market Size and Revenue Forecasts

Year	Estimated Global Revenue (USD Billion)	CAGR (%)	Notes
2023	1.2	-	Post-patent expiry generic market stabilization
2025	1.6	11.8%	Growth driven by generics and emerging markets
2030	2.8	9.3%	Due to innovations and market expansion in Asia

(Source: MarketResearch.com; projections based on epidemiology, device innovation, and competitive dynamics.)

Profitability and Investment Outlook

• Pricing pressures:
  Margins are declining in mature markets; however, value-added formulations and delivery systems can sustain profitability.

• R&D expenditure:
  Minimal for generics; primary investments are in pipeline development for combination therapies.

• Market segmentation revenue breakdown:

Segment	Share of Total Revenue	CAGR (2023–2030)	Remarks
Generic inhalers	70%	10%	Cost-driven volume growth
Branded formulations	20%	6%	Innovation and differentiation
Combination inhalers	10%	12%	High-growth niche

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How do regional markets differ in the Ipratropium Bromide landscape?

Region	Market Size (USD Billion, 2023)	Key Drivers	Challenges
North America	0.4	High COPD prevalence, reimbursement	Competition from LAMAs
Europe	0.3	Aging population, regulatory support	Price pressure in generics
Asia-Pacific	0.4	Rapid urbanization, high prevalence	Lower healthcare access
Latin America	0.1	Increasing awareness, affordability	Distribution logistics
Middle East & Africa	0.0.2	Growing disease burden	Infrastructure limitations

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What are the regulatory and policy considerations?

• Market approval pathways:
  Existing approvals facilitate rapid entry for generics, with expedited pathways in some regions such as the US FDA’s 505(b)(2) process.

• Pricing regulations:
  Stringent in European nations and some Latin American countries, impacting profitability.

• Reimbursement policies:
  Favor cost-effective inhalers; government procurement drives demand in public health systems.

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Key Strategic Implications

• Innovation vs. commoditization:
  As the market matures, brands that innovate—particularly in device technology or combination formulations—will command premium pricing.

• Market expansion in emerging economies:
  Tailored strategies in India, China, and Southeast Asia can unlock incremental growth.

• Partnerships and licensing:
  Collaborations with regional producers can enhance distribution and localization.

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FAQs

1. Will Ipratropium Bromide maintain relevance in COPD management?
Yes, despite the rise of LAMAs, Ipratropium remains a cost-effective option, especially in resource-constrained settings. It also serves as a foundational therapy often used in combination with other agents.

2. How does patent expiry affect the global market?
Patent expiration led to a surge in generic versions, reducing prices and margins but expanding patient access. It has intensified competition but also opened opportunities for low-cost providers.

3. Are combination therapies replacing monotherapies?
Yes, fixed-dose combinations (FDCs) with beta-agonists and corticosteroids are increasingly preferred for their convenience and improved efficacy, positioning Ipratropium as a component in broader treatment regimens.

4. Which regions offer the highest growth potential?
Emerging markets in Asia-Pacific, Latin America, and Africa show high growth prospects driven by increasing disease burden, healthcare access expansion, and affordability.

5. How do device innovations influence market prospects?
Smart inhalers and breath-activated devices improve adherence and outcomes, enabling premium pricing and differentiating products in competitive landscapes.

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Key Takeaways

• Market expansion is driven by demographic shifts, increasing prevalence of respiratory diseases, and the proliferation of combination and advanced delivery systems.
• Generic competition has significantly driven prices downward, pressing margins but broadening access.
• Innovation in device technology and combination therapies presents opportunities for differentiation and premium pricing.
• Emerging markets are poised as the primary growth engines for the next decade, requiring tailored regulatory and marketing approaches.
• Regulatory and policy environments influence market accessibility, product development, and profitability strategies.

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References

[^1]: World Health Organization. "Global Surveillance, Prevention and Control of Chronic Respiratory Diseases." 2019.

[^2]: U.S. Food and Drug Administration. "Approval history and regulatory guidance for Ipratropium inhalation preparations." 2000–2023.

[^3]: Taylor, R. "Patent expiries and the generic drug market." Journal of Pharmacoeconomics, 2018.

[^4]: Global Initiative for Chronic Obstructive Lung Disease (GOLD). "2023 Report."

[^5]: MarketsandMarkets. "Inhalation Devices Market by Type, Application, and Region." 2022.

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This comprehensive analysis aims to support stakeholders in strategic planning, investment assessment, and competitive positioning within the Ipratropium bromide landscape.