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, Norvium Bioscience, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, and Hikma, and is included in twenty-eight 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. Eighteen suppliers are listed for this compound.

Summary for IPRATROPIUM BROMIDE

International Patents:	10
US Patents:	1
Tradenames:	3
Applicants:	17
NDAs:	28
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	85
Patent Applications:	7,495
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
Oregon Health and Science University	Phase 2
University at Buffalo	Phase 2
Wake Forest University Health Sciences	Phase 2

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
Watson Labs	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	076291-001	May 9, 2005		DISCN	No	No
Teva Pharms Usa	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	075313-001	Feb 7, 2000		DISCN	No	No
Actavis Mid Atlantic	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	075111-001	Apr 22, 1999		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	5,766,573
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020394-001	Oct 20, 1995	4,385,048
Boehringer Ingelheim	ATROVENT	ipratropium bromide	AEROSOL, METERED;INHALATION	019085-001	Dec 29, 1986	3,681,500

International Patents for IPRATROPIUM BROMIDE

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

IPRATROPIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ipratropium Bromide

Introduction

Ipratropium bromide, an anticholinergic drug, is widely used in the management of respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. The market for ipratropium bromide is influenced by several key factors, including increasing demand for respiratory medications, technological advancements, and regulatory considerations.

Market Drivers

Increasing Prevalence of Respiratory Diseases

The rising prevalence of COPD and other respiratory disorders is a significant driver for the ipratropium bromide market. As the global population ages and exposure to pollutants increases, the demand for effective respiratory treatments is on the rise[1][4].

Expansion in Emerging Markets

Emerging economies in Asia-Pacific, Latin America, and Africa offer substantial growth opportunities due to increasing healthcare expenditures, rising disease awareness, and the expansion of healthcare infrastructure. These regions are experiencing rapid growth in the demand for respiratory medications, driven by factors such as increasing pollution levels and smoking prevalence[1].

Development of Combination Therapies

The development of combination therapies that combine ipratropium bromide with other bronchodilators or anti-inflammatory agents presents opportunities for market differentiation and improved treatment outcomes. These combinations are gaining traction due to their enhanced efficacy and convenience[1].

Market Challenges

Generic Competition

The ipratropium bromide market faces significant competition from generic products, which can lead to pricing pressures and reduced market share for branded products. Generic alternatives often offer similar efficacy at lower costs, making them attractive to cost-conscious healthcare providers and patients[1].

Regulatory Considerations

Stringent regulatory standards, particularly in mature markets like Europe, pose challenges for new product approvals and market entry. Compliance with these regulations is crucial for maintaining market presence and trust among customers[1].

Regional Analysis

North America

North America holds a significant share of the ipratropium bromide market, driven by a high prevalence of respiratory diseases and advanced healthcare infrastructure. The region is characterized by strong demand for combination therapies and ongoing research and development activities[1].

Europe

Europe is a mature market with established healthcare systems and high awareness of respiratory therapies. The region is witnessing growth in the use of ipratropium bromide for COPD management, with stringent regulatory standards governing the market[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth due to increasing pollution levels, smoking prevalence, and expanding healthcare access. The market is driven by rising demand for effective respiratory treatments and significant investments in healthcare infrastructure[1].

Latin America and Middle East & Africa

These regions are expanding with growing awareness of respiratory diseases and increasing healthcare expenditure. They present opportunities for market growth with the rising adoption of advanced respiratory therapies[1].

Competitive Landscape

The competitive landscape of the ipratropium bromide market features a mix of established pharmaceutical companies and emerging players. Key market players focus on product innovation, strategic partnerships, and expanding their distribution networks to maintain a competitive edge. Companies compete based on factors such as product efficacy, pricing, and customer support[1].

Financial Trajectory

Cost Savings through Delivery Methods

Studies have shown that switching from metered-dose inhalers (MDIs) to nebulizer treatments can result in significant cost savings. For example, an academic health system in the United States saved $99,359 over three months by substituting ipratropium-albuterol MDIs with nebulization solutions, with an extrapolated full-year savings of $397,436[2][5].

Market Growth Projections

The ipratropium bromide market is projected to experience significant growth from 2023 to 2031, driven by the upward trend in market dynamics and sustained expansion in demand for respiratory therapies. The market is expected to undergo a meticulous evaluation during the forecasted period, with a focus on diverse segments and prevailing trends[4].

Revenue Outlook

The revenue outlook for the ipratropium bromide market is positive, with projections indicating robust growth rates. The market's development will be influenced by factors such as technological advancements, regulatory developments, and shifts in healthcare demand[4].

Segmentation

By Formulation

The market can be segmented into inhalation solutions, inhalation aerosols, and nasal sprays. Inhalation solutions are widely used in hospital settings for acute respiratory management, while inhalation aerosols are popular for their convenience and ease of use in home care settings[1].

By Application

Ipratropium bromide is used for COPD treatment, asthma management, and other respiratory disorders. Its use in combination therapies is particularly noteworthy for managing severe exacerbations of asthma and COPD[1][3].

By End-User

The market is segmented by end-users such as hospitals, clinics, and home care settings. Each segment has different needs and preferences, influencing the market dynamics and product offerings[1].

Key Benefits for Industry Participants

Growth Opportunities

The expanding demand for respiratory medications and healthcare infrastructure investments provide significant growth opportunities for market players. Focusing on emerging markets and innovative product formulations can enhance market presence[1].

Technological Advancements

Investing in advanced drug formulations and delivery systems can enhance product performance and market competitiveness. Technologies like nebulizers and vibrating mesh nebulizers offer cost-effective and efficient delivery methods[2][5].

Regulatory Compliance

Adhering to regulatory standards and safety requirements ensures market acceptance and trust among customers. Compliance is crucial for maintaining a strong market position and avoiding regulatory hurdles[1].

SWOT Analysis

Strengths

• Established efficacy of ipratropium bromide
• Growing demand for combination therapies
• Expanding market presence in emerging regions[1]

Weaknesses

• Generic competition
• Regulatory complexities
• Potential side effects[1]

Opportunities

• Product innovation
• Expansion into emerging markets
• Strategic partnerships[1]

Threats

• Regulatory challenges
• Economic fluctuations
• Competition from alternative therapies[1]

Conclusion

The ipratropium bromide market is poised for steady growth, driven by rising demand for respiratory medications, advancements in drug formulations, and expanding healthcare access in emerging markets. Companies that focus on innovation, regulatory compliance, and market expansion will be well-positioned to capitalize on emerging opportunities and achieve long-term success.

Key Takeaways

• Increasing prevalence of respiratory diseases drives market growth.
• Emerging markets offer significant growth opportunities.
• Combination therapies and technological advancements are key market differentiators.
• Generic competition and regulatory complexities pose challenges.
• Cost savings can be achieved through efficient delivery methods.

FAQs

Q: What are the primary indications for ipratropium bromide?

A: Ipratropium bromide is primarily indicated for the management of COPD, asthma, and other respiratory disorders, as well as for symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis[3].

Q: How does ipratropium bromide work?

A: Ipratropium bromide acts as an antagonist of the muscarinic acetylcholine receptor, inhibiting the parasympathetic nervous system in the airways and leading to bronchodilation and reduced secretions[3].

Q: What are the key drivers of the ipratropium bromide market?

A: The market is driven by the increasing prevalence of respiratory diseases, expansion in emerging markets, and the development of combination therapies[1][4].

Q: What are the challenges faced by the ipratropium bromide market?

A: The market faces challenges such as generic competition, regulatory complexities, and potential side effects[1].

Q: How can cost savings be achieved in the delivery of ipratropium bromide?

A: Cost savings can be achieved by switching from MDIs to nebulizer treatments, as demonstrated by studies showing significant reductions in drug costs and overall healthcare expenditures[2][5].

Sources

1. MarkWide Research - Ipratropium Bromide Market 2024-2032 | Size, Share, Growth
2. Aerogen - Cost savings associated with delivery of ipratropium bromide–albuterol via the Aerogen Solo versus an MDI within an academic health system in the United States
3. DrugBank - Ipratropium: Uses, Interactions, Mechanism of Action
4. Market Research Intellect - Global Ipratropium Bromide Market Size, Scope And Forecast Report
5. PubMed - Financial effect of converting ipratropium-albuterol therapy from inhalers to nebulizer treatments at an academic health system