COMBIVENT RESPIMAT Drug Patent Profile

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

Combivent Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in thirty-five countries.

The generic ingredient in COMBIVENT RESPIMAT is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combivent Respimat

A generic version of COMBIVENT RESPIMAT was approved as albuterol sulfate; ipratropium bromide by CIPLA on December 31^st, 2007.

Summary for COMBIVENT RESPIMAT

International Patents:	72
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	5
Patent Applications:	111
Drug Prices:	Drug price information for COMBIVENT RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIVENT RESPIMAT
What excipients (inactive ingredients) are in COMBIVENT RESPIMAT?	COMBIVENT RESPIMAT excipients list
DailyMed Link:	COMBIVENT RESPIMAT at DailyMed

See drug prices for COMBIVENT RESPIMAT

Recent Clinical Trials for COMBIVENT RESPIMAT

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

Sponsor	Phase
Boehringer Ingelheim	Phase 4
Boehringer Ingelheim	Phase 2
Boehringer Ingelheim	Phase 3

See all COMBIVENT RESPIMAT clinical trials

Pharmacology for COMBIVENT RESPIMAT

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

Paragraph IV (Patent) Challenges for COMBIVENT RESPIMAT

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 COMBIVENT RESPIMAT

COMBIVENT RESPIMAT is protected by four US patents.

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 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
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 COMBIVENT RESPIMAT

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 COMBIVENT RESPIMAT

See the table below for patents covering COMBIVENT RESPIMAT around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	284636
Poland	327079
Brazil	0313816	Dispositivo de bloqueio para um mecanismo tensor de bloqueio com saìda ativada à mola
Denmark	1611958

Market Dynamics and Financial Trajectory for COMBIVENT RESPIMAT

Last updated: July 27, 2025

Introduction

COMBIVENT RESPIMAT, marketed primarily in the United States and Europe by Boehringer Ingelheim, represents a leading fixed-dose combination inhaler used for the management of chronic obstructive pulmonary disease (COPD) and certain types of asthma. This inhaler combines ipratropium bromide and albuterol sulfate, offering rapid relief and prolonged bronchodilation. As a critical asset in the respiratory therapeutics segment, its market trajectory is subject to multifaceted dynamics, including regulatory developments, competitive landscape shifts, and evolving patient needs.

Market Overview

The global respiratory drugs market is projected to grow at a CAGR of approximately 4.9% from 2023 to 2030, driven by rising prevalence of COPD and asthma, aging populations, and increasing awareness of respiratory care innovations [1]. COMBIVENT RESPIMAT, as a multipurpose inhaler, occupies a significant niche due to its dual-action mechanism, simplifying therapy regimens and improving patient adherence.

Boehringer Ingelheim's strategic positioning in the COPD segment capitalizes on a robust portfolio of inhalation therapies, with COMBIVENT RESPIMAT historically maintaining a substantial market share. However, consideration must be given to key competitive alternatives, such as Spiriva (tiotropium), Spiriva Respimat, and combination inhalers like Advair (fluticasone/salmeterol), which influence market share dynamics.

Market Drivers

Rising COPD and Asthma Prevalence

The World Health Organization estimates over 250 million individuals globally suffer from COPD, with prevalence predicted to increase due to smoking, pollution, and aging demographics [2]. Similarly, asthma affects an estimated 262 million globally [3]. The demand for effective inhalation therapies like COMBIVENT RESPIMAT aligns with these epidemiological trends, expanding its market potential.

Therapeutic Efficacy and Patient Compliance

COMBIVENT RESPIMAT offers a convenient, fixed-dose combination with rapid onset, long-lasting effects, and ease of use, promoting medication adherence in chronic management. The RESPIMAT inhaler device itself is praised for its user-friendly design, which is crucial for elder patients or those with dexterity issues, thus broadening its applicability.

Regulatory Environment

Regulatory agencies, including the FDA and EMA, continue to scrutinize inhaler approvals and label expansions to accommodate new indications or formulations. The regulatory landscape influences product lifecycle management, patent protections, and potential pipeline developments.

Competitive Landscape

The inhalation therapy market is characterized by intense competition from both branded and generic products. Key competitors for COMBIVENT RESPIMAT include:

• Spiriva Respimat (Boehringer Ingelheim): A leading LAMA (long-acting muscarinic antagonist) with higher market penetration.
• Advair (GlaxoSmithKline): A popular ICS/LAMA combination, competing in asthma and COPD sub-segments.
• Other Fixed-Dose Combinations: Such as Dulera and Symbicort, diversified by their composition.

Innovative devices like once-daily inhalers, efficacy improvements, and reduced side effects are driving product differentiation.

Market Challenges

Generic and Biosimilar Competition

Patent expirations threaten COMBIVENT RESPIMAT’s exclusivity, inviting generic and biosimilar entrants which typically exert downward pressure on prices and revenues. Boehringer Ingelheim actively manages patent portfolios to prolong market exclusivity.

Healthcare Policy and Reimbursement Shifts

Healthcare systems are increasingly emphasizing cost-effective therapies, with reimbursement policies affecting market access. Patients’ affordability and insurance coverage substantially influence utilization patterns.

Technological Advancements

Emerging inhaler technologies—such as digital inhalers with connectivity features—are setting new standards, requiring firms like Boehringer Ingelheim to invest in innovation to sustain competitive edge.

Financial Trajectory

Revenue Performance and Growth Prospects

Historical data suggest COMBIVENT RESPIMAT has contributed consistently to Boehringer Ingelheim’s respiratory franchise revenues. The incremental rise in COPD prevalence and heightened awareness amplify future sales prospects. However, anticipated patent expiry dates and impending biosimilar entries forecast a moderate decline in peak revenues over the next 5–7 years.

Strategic Initiatives and Pipeline Development

Boehringer Ingelheim’s strategic pipeline includes next-generation inhalers and novel combination therapies aimed at enhancing efficacy and patient compliance. These initiatives are projected to mitigate revenue decline from existing patents and extend the product’s life cycle.

Potential for Market Expansion

Emerging markets, including Asia-Pacific and Latin America, present significant growth opportunities due to increasing COPD prevalence, rising disposable incomes, and expanding healthcare infrastructure. Local regulatory approvals and tailored marketing strategies are pivotal to capturing these markets.

Future Outlook and Market Trends

• Digital Integration: Incorporation of smart inhalers with dose tracking and telemedicine-compatible features will reshape usage patterns.
• Personalized Medicine: Genomic and phenotypic profiling may influence prescribing practices, favoring more tailored inhalation therapies.
• Regulatory Advances: Faster approvals for combination therapies and new indications will unlock additional revenue streams.
• Competitive Innovations: Development of once-daily inhalers, minimizing side effects, and optimizing drug delivery will determine market shares.

Conclusion

COMBIVENT RESPIMAT’s market dynamics are shaped by epidemiological trends, technological innovation, and competitive pressures, with an overarching trajectory sensitive to patent protections, healthcare policies, and emerging digital health solutions. While current revenues are robust, future growth hinges on strategic innovation, geographical expansion, and adaptation to evolving regulatory landscapes.

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Key Takeaways

• The global respiratory market’s growth, driven by COPD and asthma prevalence, underpins COMBIVENT RESPIMAT’s long-term demand.
• Competition from branded inhalers and generics presents both challenges and opportunities for market share adjustments.
• Patent expirations and biosimilar entries necessitate innovation and pipeline development for sustained revenues.
• Expansion in emerging markets and technological advancements such as digital inhalers will be critical growth drivers.
• Strategic focus on regulatory agility, patient-centric formulations, and digital integration will influence profitability and market positioning.

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FAQs

1. How does COMBIVENT RESPIMAT compare to its competitors in terms of efficacy?
COMBIVENT RESPIMAT offers rapid bronchodilation with proven efficacy in COPD management, similar to other combination inhalers like Advair. Its dual-agent approach simplifies treatment regimens, potentially improving adherence compared to single-agent therapies. Clinicians favor its ease of use and onset of action, though individual patient response varies.

2. What factors could affect COMBIVENT RESPIMAT’s market share in the next five years?
Patent expirations, the entry of biosimilars, technological innovations in inhaler design, regulatory policy changes, and shifts in healthcare reimbursement will significantly influence market share dynamics. Successful pipeline development and strategic geographical expansion are also crucial.

3. Are there any upcoming regulatory approvals that could impact COMBIVENT RESPIMAT?
Future approvals for new indications, formulations, or delivery devices could enhance its market footprint. Conversely, regulatory crackdowns on inhaler safety or quality issues could pose risks. Active monitoring of regulatory agencies' updates is essential.

4. How are digital health trends influencing the future of respiratory inhalers?
Digital inhalers equipped with connectivity features enable dose tracking, adherence monitoring, and integration with telehealth platforms. These innovations are likely to improve patient outcomes and create competitive advantages for brands adopting such technologies.

5. What strategic moves can manufacturers adopt to protect COMBIVENT RESPIMAT’s market position?
Investing in pipeline innovation, securing patent protections, expanding into emerging markets, integrating digital features, and fostering strategic partnerships will help maintain a competitive edge and buffer against generic competition.

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References

1. Research and Markets. "Global Respiratory Drugs Market," 2023.
2. WHO. "Chronic Obstructive Pulmonary Disease (COPD)," 2022.
3. Global Initiative for Asthma (GINA). "Global Strategy for Asthma Management and Prevention," 2022.