DUONEB Drug Patent Profile

Which patents cover Duoneb, and when can generic versions of Duoneb launch?

Duoneb is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in DUONEB 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 Duoneb

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

Summary for DUONEB

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	2
DailyMed Link:	DUONEB at DailyMed

Recent Clinical Trials for DUONEB

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

Sponsor	Phase
University Hospitals Cleveland Medical Center	Phase 1
Shin-hwar Wu	N/A

See all DUONEB clinical trials

US Patents and Regulatory Information for DUONEB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	DUONEB	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	020950-001	Mar 21, 2001		DISCN	Yes	No

Expired US Patents for DUONEB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	DUONEB	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	020950-001	Mar 21, 2001	6,632,842

International Patents for DUONEB

See the table below for patents covering DUONEB around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	552548	An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease
Mexico	PA04003927	UNA SOLUCION DE INHALACION DE ALBUTEROL E IPRATROPIO, SISTEMA, EQUIPO Y METODO PARA ALIVIAR SINTOMAS DE ENFERMEDAD PULMONAR OBSTRUCTIVA CRONICA. (AN ALBUTEROL AND IPRATROPIUM INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE.)
Canada	2464735	SOLUTION D'INHALATION A BASE D'ALBUTEROL ET D'IPRATROPIUM, ET SYSTEME, KIT ET METHODE PERMETTANT DE SOULAGER LES SYMPTOMES DE LA BRONCHOPNEUMOPATHIE CHRONIQUE OBSTRUCTIVE (AN ALBUTEROL AND IPRATROPIUM INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
Japan	2010235617	METHOD FOR PREPARING ALBUTEROL AND IPRATROPIUM INHALATION SOLUTION FOR RELIEVING SYMPTOM OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND PREPACKAGE TREATMENT SYSTEM
World Intellectual Property Organization (WIPO)	2004091536
Australia	2006202585
China	1939279

DUONEB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DuoNeb

Introduction

DuoNeb, a combination of the β2-adrenergic bronchodilator albuterol sulfate and the anticholinergic bronchodilator ipratropium bromide, is a crucial medication for managing bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD). Understanding the market dynamics and financial trajectory of DuoNeb is essential for pharmaceutical companies, healthcare providers, and patients alike.

Market Context

The pharmaceutical market, particularly for respiratory medications, is complex and influenced by various factors such as regulatory changes, competition from generics, and evolving patient needs.

Drug Expenditure Trends

Drug spending in the U.S. has seen significant growth over the past few decades. According to IQVIA, real net per capita drug spending has increased by 20% from 2010 to 2020, while manufacturer net revenue has grown by 5% during the same period[3].

Competitive Landscape

DuoNeb competes in a market dominated by both branded and generic respiratory medications. The generic share of combined generic and loss-of-exclusivity (LOE) segments has been increasing steadily, which can impact the market share of branded products like DuoNeb[3].

Clinical Efficacy and Patient Outcomes

Clinical Trials

Clinical trials have demonstrated the efficacy of DuoNeb in improving pulmonary function in COPD patients. A 12-week randomized study showed that DuoNeb provided better changes in FEV1 (forced expiratory volume in one second) compared to albuterol sulfate or ipratropium bromide alone. It also exhibited a rapid onset and extended duration of action, combining the benefits of both components[4].

Patient Compliance and Resource Utilization

A population-based retrospective claims analysis indicated that patients using DuoNeb had lower emergency department (ED) costs and fewer ED visits compared to those using generic ipratropium and albuterol (dual single agents). This study also found that the DuoNeb cohort had fewer therapy interruptions, which can improve patient compliance and overall health outcomes[1].

Economic Profile

Expenditures and Resource Utilization

The economic analysis of DuoNeb versus generic ipratropium and albuterol revealed that total per-member-per-month (PMPM) expenditures were lower for DuoNeb ($1,840.36) compared to the generic combination ($2,046.73), although the difference was not statistically significant. However, ED costs were significantly lower for DuoNeb ($36.67 vs $52.84)[1].

Inpatient and Outpatient Costs

Inpatient expenditures represented the largest portion of total costs, with DuoNeb associated with lower inpatient costs ($874.97) compared to the generic combination ($1,105.80). This suggests that DuoNeb may help reduce the overall healthcare burden by minimizing hospitalizations[1].

Regulatory and Reimbursement Environment

FDA Regulations and User Fees

The FDA's regulatory environment plays a crucial role in the approval and maintenance of pharmaceutical products. Increases in user fees for medical device and drug reviews, as requested in the FDA's budget, can impact the cost structure and development timelines for medications like DuoNeb[2].

Reimbursement and Payer Dynamics

Reimbursement policies and payer dynamics significantly influence the financial trajectory of pharmaceuticals. The use of discounts and rebates can reduce the net spending on drugs, affecting the manufacturer's revenue. For instance, IQVIA reports that off-invoice discounts and rebates have offset list prices, leading to slower net revenue growth for pharmaceutical companies[3].

Market Forecast and Growth Drivers

Spending Growth and Projections

The U.S. drug spending is projected to continue growing, driven by the uptake of novel therapies and the increasing prevalence of chronic diseases. However, the growth in net manufacturer revenues is expected to be slower due to discounts and rebates[3].

Specific Therapeutic Areas

In the respiratory segment, the introduction of new therapies and the shift towards more effective treatments can drive growth. DuoNeb, being a combination therapy, benefits from its comprehensive action on bronchospasm, making it a preferred choice for patients requiring multiple bronchodilators[4].

Financial Trajectory

Revenue and Cost Analysis

The financial performance of DuoNeb is influenced by its market share, pricing strategies, and competition from generics. While the drug may not be more expensive than generic alternatives, its lower ED costs and fewer therapy interruptions can lead to better health outcomes and reduced overall healthcare expenditures[1].

Future Outlook

Given the increasing demand for effective COPD treatments and the clinical benefits of DuoNeb, the drug is likely to maintain a significant market presence. However, continuous monitoring of market dynamics, regulatory changes, and reimbursement policies will be essential to navigate the evolving pharmaceutical landscape.

Key Takeaways

• Clinical Efficacy: DuoNeb demonstrates superior bronchodilator efficacy compared to single-agent treatments.
• Economic Benefits: Lower ED costs and fewer therapy interruptions contribute to reduced healthcare expenditures.
• Market Dynamics: The drug competes in a market influenced by generics, regulatory changes, and reimbursement policies.
• Financial Trajectory: DuoNeb's financial performance is driven by its market share, pricing, and the overall healthcare cost savings it provides.

FAQs

What is DuoNeb used for?

DuoNeb is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator[4].

How does DuoNeb compare to generic ipratropium and albuterol?

DuoNeb has been associated with lower ED costs, fewer ED visits, and fewer therapy interruptions compared to generic ipratropium and albuterol[1].

What are the key drivers of growth in the respiratory medication market?

The market is driven by the uptake of novel therapies, increasing prevalence of chronic diseases, and the shift towards more effective treatments[3].

How do regulatory changes impact DuoNeb?

Regulatory changes, such as increases in user fees and reimbursement policies, can affect the development and maintenance costs of DuoNeb[2].

What is the projected financial outlook for DuoNeb?

DuoNeb is expected to maintain a significant market presence due to its clinical benefits, but its financial performance will depend on market dynamics, regulatory changes, and reimbursement policies[3].

Sources

1. Exploratory economic evaluation of patients with COPD on a nebulized ipratropium and albuterol combination product - PubMed.
2. AGRICULTURE, RURAL DEVELOPMENT, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2006 - Congress.gov.
3. Drug Expenditure Dynamics 1995-2020: Understanding Medicine Spending in Context U.S Detail Appendix - IQVIA.
4. DuoNeb Inhalation Solution - FDA.