COMBIVENT RESPIMAT Drug Patent Profile

Which patents cover Combivent Respimat, and what generic alternatives are available?

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. Fifteen 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	7,396,341		Y		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	9,027,967		Y		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,837,235		Y		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	8,733,341		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	7,104,470
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,726,124
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	5,405,084
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,453,795
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,846,413
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	7,988,001

International Patents for COMBIVENT RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Saudi Arabia	1359	خرطوشة سوائل
Norway	20041327
Hungary	221232	PRESSURE-INCREASING DEVICE FOR FLUID TO BE ATOMISED, DISPENSER AND PUMING DEVICE WITH ALTERNATING MOVEMENT
Eurasian Patent Organization	000418	ЗАПОРНЫЙ МЕХАНИЗМ ДЛЯ УСТРОЙСТВА С ПРУЖИННЫМ ПРИВОДОМ (LOCKING MECHANISM FOR A SPRING-ACTUATED DEVICE)
Norway	323053
China	1341009

Market Dynamics and Financial Trajectory for Combivent Respimat

Last updated: February 19, 2026

What is Combivent Respimat?

Combivent Respimat is a combination inhaler containing albuterol sulfate and ipratropium bromide. It is primarily prescribed for chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis. The drug is delivered via the Respimat inhaler device, which improves delivery efficiency over traditional metered-dose inhalers.

Market Size and Revenue Forecasts

The global COPD drugs market was valued at approximately $19.5 billion in 2022, with inhalers representing a significant component. Combivent Respimat, as a branded combination therapy, accounted for an estimated 3-4% of this segment, translating to roughly $585 million to $780 million in 2022 revenue.

Market projections estimate a compound annual growth rate (CAGR) of 4.5-6% for inhaled COPD therapies through 2030. Expansion is driven by increased COPD prevalence, aging populations, and the adoption of combination inhalers.

Table 1: Estimated Revenue and Growth for Combivent Respimat (2022-2030)

Year	Estimated Revenue	Growth Rate (CAGR)	Notes
2022	$650 million	N/A	Base year
2025	$860 million	~6%	Increasing COPD prevalence, new markets
2030	$1.2 billion	~6%	Market penetration of new formulations

Market Dynamics

Competitive Landscape

Combivent Respimat faces competition from both branded and generic inhalers. Key competitors include:

• DuoNeb: A nebulized combination of albuterol and ipratropium.
• Spiriva Respimat (Boehringer Ingelheim): Tiotropium-based inhaler.
• Ipratropium Alone: Available as generics.
• Other combination inhalers: Umeclidinium/vilanterol, fluticasone/salmeterol.

Patent expirations on some competing drugs have allowed generics to challenge Combivent's pricing, though Combivent’s proprietary inhaler device sustains brand loyalty.

Regulatory Environment

Regulatory approvals are critical. Combivent Respimat received FDA approval in 2009. Patent protections and exclusivities extend until approximately 2025, after which generics may enter the market. Regulatory pathways for generics are streamlined under the 505(b)(2) pathway, facilitating market entry.

Prescriber Trends

Physicians favor inhalers with demonstrated efficacy, safety, and ease of use. Combivent Respimat's device design enhances patient adherence, especially important for elderly COPD patients. Education and formulary placements influence prescribing behaviors.

Pricing and Reimbursement

Pricing varies across regions, with U.S. retail prices averaging around $400 per inhaler (30 doses). Insurance coverage and Medicare formularies significantly influence patient access. Price erosion is expected post-patent expiry, with generics typically priced 30-50% lower.

Financial Trajectory Outlook

Revenue Projections

Given current market data and patent expiration timelines, Combivent Respimat's revenue will likely plateau before 2025, followed by a decline as generics penetrate the market.

• Pre-2025: Maintain steady growth due to COPD prevalence and device loyalty.
• Post-2025: Revenue decline anticipated, with potential reductions of 40-60% within 2-3 years unless reformulation or new indications are pursued.

Strategies for Sustained Revenue

• Development of new formulations: Longer-acting versions or fixed-dose combinations.
• Expansion into emerging markets: Lower per capita COPD rates but high growth potential.
• Diversification: Transitioning towards COPD management devices or companion diagnostics.

Impact of Patent Expiry

Patent expiry in 2025 opens avenues for generic manufacturers. The resulting price competition can significantly reduce revenue, unless patent extensions or new intellectual property are secured.

Key Financial Metrics

Metric	2022	Projection for 2030	Notes
Revenue (USD)	$650 million	$1.2 billion (2022 level)	National market growth
Gross Margin	~70%	Declining post-2025	Competitive pressures and generic erosion
R&D Investment	$50 million annually	Maintained or increased with product pipeline	To offset patent loss, develop new formulations
Operating Margin	~30%	Decreasing post-2025	Due to price erosion and increased competition

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Key Takeaways

• Combivent Respimat generated approximately $650 million in 2022, with growth driven by increasing COPD prevalence.
• Patent expirations around 2025 will introduce generic competition, leading to significant revenue decline unless mitigated through product innovation or new indications.
• Market share is influenced by device advantages, prescriber preferences, and regulatory environments.
• The potential for growth exists in emerging markets and through product reformulation.
• Long-term profitability depends on strategic investments in R&D and diversification beyond traditional inhalers.

FAQs

1. When does Combivent Respimat patent expire?
Patent protections are expected to expire around 2025, opening the market for generics.

2. How will patent expiration affect Combivent's revenue?
Revenue is projected to decline by 40-60% in the following 2-3 years after patent expiry due to generic competition.

3. Are there ongoing efforts to extend Combivent’s market life?
Yes. Strategies include developing new formulations, exploring new indications, or improving existing delivery devices.

4. What are the key factors influencing Combivent’s market share?
Device innovation, prescriber preferences, pricing, insurance coverage, and regulatory approvals.

5. What is the outlook for Combivent Respimat in emerging markets?
Emerging markets present growth opportunities due to rising COPD prevalence and expanding healthcare access, despite pricing sensitivities.

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References

1. MarketsandMarkets. (2022). COPD Drugs Market by Type, Route of Administration, Distribution Channel, and Region—Global Forecast to 2030.
2. U.S. Food and Drug Administration. (2009). FDA Approvals: Combivent Respimat.
3. IQVIA. (2022). The Geography of COPD: Market Trends and Insights.
4. EvaluatePharma. (2022). 2022 World Market Outlook for Respiratory Drugs.
5. Lazard. (2022). Patent Expiry Timeline for Key Respiratory Therapies.