ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - Generic Drug Details

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

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Aiping Pharm Inc, Apotex Inc, Cipla, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Pharmobedient, and is included in twelve NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; ipratropium bromide has seventy-two patent family members in thirty-five countries.

Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

International Patents:	72
US Patents:	4
Tradenames:	4
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	16
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
DailyMed Link:	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE at DailyMed

Recent Clinical Trials for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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

Sponsor	Phase
James J. Peters Veterans Affairs Medical Center	Phase 2
University of Texas Southwestern Medical Center	Phase 4
Dey	Phase 3

See all ALBUTEROL SULFATE; IPRATROPIUM BROMIDE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ALBUTEROL SULFATE; 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 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIVENT RESPIMAT	Inhalation Aerosol	albuterol sulfate; ipratropium bromide	100 mcg/20 mcg per actuation	021747	1	2023-03-30

US Patents and Regulatory Information for ALBUTEROL SULFATE; 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	COMBIVENT	albuterol sulfate; ipratropium bromide	AEROSOL, METERED;INHALATION	020291-001	Oct 24, 1996		DISCN	No	No
Watson Labs Teva	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	077063-001	Dec 31, 2007		DISCN	No	No
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y		Y

Expired US Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011

International Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1084909	Blocking device for a sprung lock with a spring operation
World Intellectual Property Organization (WIPO)	2004024340
World Intellectual Property Organization (WIPO)	2005065836
Russian Federation	2005108975	БЛОКИРОВОЧНОЕ ПРИСПОСОБЛЕНИЕ ДЛЯ СТОПОРНО-ЗАЖИМНОГО МЕХАНИЗМА С ВЫХОДНЫМ ЗВЕНОМ С ПРУЖИННЫМ ПРИВОДОМ

Market Dynamics and Financial Trajectory for Albuterol Sulfate and Ipratropium Bromide

Last updated: August 1, 2025

Introduction

The combination of Albuterol Sulfate and Ipratropium Bromide is a cornerstone in respiratory therapy, primarily used in managing obstructive airway diseases such as COPD and asthma. Their synergistic effects improve bronchodilation, leading to significant clinical benefits. This article examines market dynamics and financial projections surrounding these medications, factoring in regulatory, clinical, and competitive landscapes to inform decision-making for stakeholders.

Market Overview

The global respiratory drug market is experiencing substantial growth, driven by rising prevalence of respiratory diseases and expanding aging populations. Key drivers include increased awareness of chronic obstructive pulmonary disease (COPD) and asthma, growing urban pollution, and advances in inhaler technology that enhance drug delivery. Within this ecosystem, combination therapies featuring Albuterol Sulfate and Ipratropium Bromide have established prominence due to their proven efficacy and safety profiles.

Market Drivers

1. Rising Burden of Respiratory Diseases

COPD affects over 200 million globally, with projections indicating an increase due to aging populations and environmental factors [1]. Asthma remains prevalent, impacting an estimated 262 million individuals worldwide [2]. The demand for efficacious bronchodilator formulations directly fuels sales of drugs combining Albuterol and Ipratropium Bromide.

2. Therapeutic Effectiveness and Safety Profile

The combination therapy offers a rapid onset of action and improved symptom control compared to monotherapy. Clinical guidelines endorse their use for acute exacerbations and maintenance therapy, which sustains steady demand.

3. Technological Advancements

Innovations in inhaler devices—metered-dose inhalers (MDIs), dry powder inhalers (DPIs)—have enhanced patient adherence and drug delivery efficiency, boosting market penetration.

4. Regulatory Approvals and Label Expansions

Regulatory agencies, including the FDA and EMA, have approved combination formulations for broad indications, expanding the potential patient base and enabling market growth.

Market Challenges

1. Patent Expirations and Generic Competition

Generic versions of these drugs are increasingly entering markets post-patent expiry, exerting pricing pressures on branded formulations. For example, the patent for Combivent, a combination inhaler, expired in 2017, leading to increased generic availability [3].

2. Pricing and Reimbursement Dynamics

Healthcare payers are scrutinizing drug costs, favoring lower-cost alternatives, which impacts revenue streams for branded products.

3. Market Saturation in Developed Economies

While developed markets demonstrate high penetration, growth potential is tapering due to market maturity and existing competition.

Regional Market Analysis

North America: The largest market with high COPD and asthma prevalence, robust healthcare infrastructure, and high reimbursement rates. The US accounted for approximately 45% of the global respiratory drug sales in 2022 [4].

Europe: Growing demand supported by increasing disease awareness and reimbursement schemes, with key players expanding product lines.

Asia-Pacific: The fastest-growing region driven by rising urban pollution, increasing healthcare access, and aging populations. Market CAGR projected at 8% over the next five years [5].

Financial Trajectory Analysis

Market Revenue Projections
The global market for respiratory combination therapies, including Albuterol Sulfate and Ipratropium Bromide, is expected to reach USD 8.5 billion by 2027, growing at a compounded annual growth rate (CAGR) of 6% from 2022 to 2027 [4].

Key Revenue Drivers

• Expanded Indications: Including acute bronchospasm and COPD exacerbations broadens the market.
• Formulation Innovations: Transition to more patient-friendly inhaler devices augments adherence.
• Emerging Markets Expansion: Entry into developing regions is projected to contribute significantly to revenue growth, compensating for saturation in mature markets.

Profitability Outlook
Manufacturers with proprietary formulations and strong patent protections are poised for higher margins. However, increasing generic competition will compress pricing, especially in mature markets. Strategic investments in R&D and device differentiation can maintain competitive edges.

Regulatory and Competitive Landscape

Regulatory agencies continue to streamline approval processes for inhaled therapies emphasizing safety and efficacy, but patent challenges remain. Market players include established pharmaceutical giants like Boehringer Ingelheim, Cipla, and Teva, all pursuing strategies such as biosimilars, line extensions, and digital health integration to sustain market share.

Strategic Implications

Manufacturers should prioritize innovation, particularly in inhaler technology, digital health integrations, and personalized medicine, to differentiate amid commoditization. Collaborations with healthcare providers and payers can foster market access and adherence initiatives.

Conclusion

The market for Albuterol Sulfate and Ipratropium Bromide combination therapies is poised for steady growth, driven by demographic trends, regulatory support, and technological advancements. Nevertheless, increasing generic competition and pricing pressures require companies to adopt innovative strategies to sustain profitability. Emerging markets present significant opportunities, provided localized regulatory pathways and reimbursement landscapes are navigated effectively.

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Key Takeaways

• The respiratory drug market's growth is fueled by rising respiratory disease prevalence and technological innovations in inhaler devices.
• Patent expirations and generic competition pose significant challenges, necessitating differentiation strategies.
• Emerging markets are the most promising growth avenues, with projected CAGR of around 8%.
• Manufacturers should focus on device innovation, digital health integration, and strategic partnerships to enhance market share.
• Regulatory agility and cost-effective manufacturing are vital for maintaining profitability in commoditized segments.

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FAQs

1. What factors influence the pricing and reimbursement of Albuterol Sulfate and Ipratropium Bromide combination therapies?
Pricing is affected by patent status, production costs, competitive landscape, and healthcare policy. Reimbursement varies based on healthcare system regulations, formulary placements, and negotiated discounts, impacting market access and profitability.

2. How will patent expirations impact the market for these drugs?
Patent expirations lead to increased generic availability, driving down prices and reducing revenue for branded formulations. Companies must innovate or diversify their portfolios to offset revenue losses.

3. What role does device innovation play in the financial trajectory of inhaled therapies?
Enhanced inhaler devices improve drug delivery efficiency, patient adherence, and clinical outcomes, creating opportunities for premium pricing and market differentiation.

4. Can emerging markets sustain growth for respiratory combination therapies?
Yes, driven by increasing disease prevalence, urban pollution, and expanding healthcare infrastructure, these markets offer high-growth potential if regulatory and logistical challenges are managed effectively.

5. How do regulatory trends influence future market projections?
Regulatory agencies are facilitating faster approvals for combination inhalers and biosimilars, which can accelerate market entry and competition. Conversely, stringent safety requirements might affect development timelines and costs.

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Sources:
[1] World Health Organization. (2022). Global surveillance and prevalence data for COPD.
[2] Global Initiative for Asthma (GINA). (2022). Global asthma prevalence data.
[3] U.S. Patent and Trademark Office. (2017). Patent expiry of Combivent.
[4] Market Research Future. (2022). Respiratory Drugs Market Analysis.
[5] Mordor Intelligence. (2022). Asia-Pacific Respiratory Drugs Market Forecast.