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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighteen patent family members in thirty-six 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:	118
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	5
Patent Applications:	12
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 six 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
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,896,264		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,284,474		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,837,235		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	6,007,676
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	7,284,474
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	5,405,084

International Patents for COMBIVENT RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Poland	327571
Germany	69117193
Finland	104311
New Zealand	320158	Device for mounting a component exposed to a pressurized fluid

COMBIVENT RESPIMAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMBIVENT RESPIMAT

Introduction

COMBIVENT RESPIMAT, developed by Boehringer Ingelheim, is a significant advancement in the treatment of chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of this drug, highlighting its development, clinical efficacy, market positioning, and financial performance.

Development and Approval

COMBIVENT RESPIMAT was approved by the U.S. Food and Drug Administration (FDA) in October 2011. It is a propellant-free inhaler that uses a slow-moving mist to deliver the active ingredients ipratropium bromide and albuterol sulfate, replacing the older COMBIVENT MDI which used chlorofluorocarbons (CFCs) as propellants[1][4].

Clinical Efficacy

Clinical studies have shown that COMBIVENT RESPIMAT is clinically comparable to COMBIVENT MDI in terms of FEV1 (the maximal amount of air that can be forcefully exhaled in one second). The combination of ipratropium bromide and albuterol sulfate in COMBIVENT RESPIMAT provides patients with significantly greater improvement in lung function compared to either component alone[1][3][4].

Market Positioning

COMBIVENT RESPIMAT is one of the few short-acting bronchodilator products that offer two different medicines in a single inhaler. This unique feature, along with its propellant-free delivery mechanism, positions it as a preferred option for patients with COPD who require a second bronchodilator. The drug's availability by prescription in the United States since 2012 has helped it gain a significant market share in the respiratory disease treatment segment[1][4].

Transition from COMBIVENT MDI

To facilitate a smooth transition from COMBIVENT MDI to COMBIVENT RESPIMAT, Boehringer Ingelheim ensured that COMBIVENT MDI remained available until mid-2013. This transition period was supported by training tools and educational resources for both healthcare professionals and patients to understand the new inhaler mechanism[1][4].

Financial Performance

COMBIVENT RESPIMAT has been a notable contributor to Boehringer Ingelheim's revenue. In 2015, it generated $892 million in revenue, making it one of the company's top brands[5].

Revenue Growth

The drug's revenue has been steady, reflecting its strong market position. As part of Boehringer Ingelheim's Human Pharma segment, which accounts for 74% of the company's net sales, COMBIVENT RESPIMAT benefits from the company's robust sales network and marketing efforts[2][5].

Global Reach

Boehringer Ingelheim's global revenue, which includes sales from COMBIVENT RESPIMAT, has shown consistent growth. In 2020, the company reported net sales of 19,566 million EUR, with the Americas, Europe, and Asia/Australia/Africa regions contributing significantly to this figure[2].

Cost and Accessibility

While COMBIVENT RESPIMAT is available only as a brand-name medication and is not currently available in generic form, the active ingredients ipratropium and albuterol are available as a generic solution used in nebulizers. This generic alternative is generally less expensive than COMBIVENT RESPIMAT, although the actual cost to patients depends on insurance plans, location, and pharmacy[3].

Competitive Landscape

In the COPD treatment market, COMBIVENT RESPIMAT competes with other brand-name drugs like Symbicort. However, its unique propellant-free delivery mechanism and the combination of two active ingredients in a single inhaler set it apart from competitors. Symbicort, while less expensive, does not offer the same combination of ipratropium and albuterol in a single device[3].

Research and Development

Boehringer Ingelheim's commitment to research and development is evident in the continuous improvement and expansion of its product portfolio. The company's R&D expenses have increased, reflecting its focus on developing new treatments and improving existing ones. This includes exploring the potential of several late-stage investigational compounds delivered by the RESPIMAT inhaler[2][4].

Key Takeaways

• Clinical Efficacy: COMBIVENT RESPIMAT is clinically comparable to COMBIVENT MDI and offers significant improvement in lung function for COPD patients.
• Market Positioning: It is one of the few short-acting bronchodilators offering two medicines in a single inhaler, with a propellant-free delivery mechanism.
• Financial Performance: The drug has generated substantial revenue and is a top brand for Boehringer Ingelheim.
• Cost and Accessibility: While it is a brand-name medication, generic alternatives are available, though in different forms.
• Competitive Landscape: It competes with other brand-name drugs but stands out due to its unique delivery mechanism and combination of active ingredients.

FAQs

1. What is COMBIVENT RESPIMAT used for? COMBIVENT RESPIMAT is used to treat chronic obstructive pulmonary disease (COPD) in adults who require a second bronchodilator.

2. How does COMBIVENT RESPIMAT differ from COMBIVENT MDI? COMBIVENT RESPIMAT uses a propellant-free delivery mechanism with a slow-moving mist, whereas COMBIVENT MDI uses chlorofluorocarbons (CFCs) as propellants.

3. Is COMBIVENT RESPIMAT available in generic form? No, COMBIVENT RESPIMAT is not currently available in generic form, but the active ingredients ipratropium and albuterol are available as a generic solution for use in nebulizers.

4. How does COMBIVENT RESPIMAT compare to other COPD treatments like Symbicort? COMBIVENT RESPIMAT offers a unique combination of ipratropium and albuterol in a single inhaler, which is not available in Symbicort. However, Symbicort is generally less expensive.

5. What were the key reasons for developing COMBIVENT RESPIMAT? The development of COMBIVENT RESPIMAT was driven by the need to replace COMBIVENT MDI, which used CFCs as propellants, in compliance with the Montreal Protocol, and to provide a more environmentally friendly and effective treatment option for COPD patients.

Cited Sources

1. FDA Approves Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) - PR Newswire.
2. Boehringer Ingelheim Annual Report 2020 - Annual Reports.
3. Combivent Respimat: Dosage, side effects, alternatives, and more - Medical News Today.
4. Boehringer Ingelheim Launches Combivent® Respimat (ipratropium bromide and albuterol) Inhalation Spray for Chronic Obstructive Pulmonary Disease (COPD) - PR Newswire.
5. 2015 Top 20 Companies: Boehringer Ingelheim - MM+M.