ACCUNEB Drug Patent Profile

When do Accuneb patents expire, and what generic alternatives are available?

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

The generic ingredient in ACCUNEB is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accuneb

A generic version of ACCUNEB was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for ACCUNEB

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	5,671
Drug Prices:	Drug price information for ACCUNEB
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACCUNEB
DailyMed Link:	ACCUNEB at DailyMed

See drug prices for ACCUNEB

Recent Clinical Trials for ACCUNEB

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

Sponsor	Phase
University of Florida

See all ACCUNEB clinical trials

Paragraph IV (Patent) Challenges for ACCUNEB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCUNEB	Inhalation Solution	albuterol sulfate	0.021%	020949	1	2005-10-19
ACCUNEB	Inhalation Solution	albuterol sulfate	0.042%	020949	1	2004-04-06

US Patents and Regulatory Information for ACCUNEB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-002	Apr 30, 2001		DISCN	Yes	No
Norvium Bioscience	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001		DISCN	Yes	No

Expired US Patents for ACCUNEB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-002	Apr 30, 2001
Norvium Bioscience	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001

International Patents for ACCUNEB

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	550304	An antimicrobial preservative-free albuterol inhalation solution for the relief of bronchospasm in children with asthma
World Intellectual Property Organization (WIPO)	03037317
Australia	2006202584
Mexico	PA04003928	SOLUCION PARA INHALACION DE ALBUTEROL, SISTEMA, EQUIPO Y METODO PARA ALIVIAR SINTOMAS DE ASMA PEDIATRICA. (ALBUTEROL INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF PEDIATRIC ASTHMA.)
Japan	2003212764	ALBUTEROL INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF PEDIATRIC ASTHMA
Australia	2002347948
Canada	2464660	SOLUTION D'INHALATION A BASE D'ALBUTEROL, ET SYSTEME, KIT ET METHODE PERMETTANT DE SOULAGER LES SYMPTOMES DE L'ASTHME PEDIATRIQUE (ALBUTEROL INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF PEDIATRIC ASTHMA)

ACCUNEB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inhalation and Nasal Spray Generic Drugs: A Focus on Accuneb

Introduction

The market for inhalation and nasal spray generic drugs is experiencing significant growth, driven by increasing demand for affordable and effective treatments for respiratory and other conditions. This article will delve into the market dynamics and financial trajectory of this sector, with a particular focus on Accuneb, a generic version of albuterol inhalation aerosol.

Global Market Overview

The global inhalation and nasal spray generic drugs market was valued at USD 30.08 billion in 2024 and is projected to grow at a CAGR of 8.56% from 2025 to 2030[1].

Key Market Drivers

Launch of New Products

The market is driven by the launch of new generic products, particularly combination drugs. For instance, Apotex Inc.'s launch of a generic version of Dymista, a combination of azelastine and fluticasone, has contributed significantly to market growth[1].

Rising Demand for Generics

The increasing demand for generic versions of inhalation and nasal spray drugs, especially for chronic conditions like COPD and asthma, is a major driver. Mylan N.V.’s Wixela Inhub, a generic counterpart of Advair Diskus, is an example of this trend[1].

Regional Growth

North America dominates the market, with a revenue share of over 35% in 2021. This is attributed to the launch of new products, acquisitions, partnerships, and the high prevalence of chronic respiratory diseases in the region[1].

Accuneb: A Generic Albuterol Inhalation Aerosol

Market Position

Accuneb, a generic version of albuterol inhalation aerosol, is used for the treatment of bronchospasm associated with asthma and COPD. It falls under the bronchodilators segment, which is a significant part of the inhalation drugs market.

Market Size and Growth

The bronchodilators market, which includes Accuneb, was estimated at USD 22.19 billion in 2022 and is expected to expand at a CAGR of 3.29% from 2022 to 2030[4].

Competitive Landscape

The market for bronchodilators is competitive, with several key players. The launch of generic versions like Accuneb has increased competition, driving down prices and making these medications more accessible to patients.

Financial Trajectory

Revenue Forecast

The revenue forecast for the inhalation and nasal spray generic drugs market, including Accuneb, is robust. The market is expected to reach USD 38.4 billion by 2030, growing at a CAGR of 8.96% from 2022 to 2030[1].

Operational Costs

Companies involved in the production and distribution of generic inhalation drugs like Accuneb face significant operational costs. For example, research and development expenses, as seen in the case of Acumen Pharmaceuticals, can be substantial due to clinical trial costs and licensing fees[2][5].

Cash Flow and Funding

The financial health of companies in this sector is crucial for sustaining operations. For instance, Acumen Pharmaceuticals, though not directly related to Accuneb, has a cash balance that is expected to support its clinical and operational activities into the first half of 2027. This highlights the importance of strong cash reserves in the pharmaceutical industry[3][5].

Regional Dynamics

North America

North America is a key market for inhalation and nasal spray generic drugs, including Accuneb. The region's high prevalence of chronic respiratory diseases and the launch of new generic products drive market growth[1].

Other Regions

Europe, Asia Pacific, Latin America, and the Middle East & Africa also contribute to the market, though at varying growth rates. The global reach of generic drugs like Accuneb is expanding due to increasing demand and regulatory approvals[1].

Patient Demographics and End-User Analysis

Patient Demographics

The patient demographics for Accuneb include individuals suffering from asthma and COPD. The prevalence of these conditions, particularly in older adults, drives the demand for affordable and effective treatments[1].

End-User Analysis

The end-users of Accuneb are primarily hospitals, clinics, and retail pharmacies. The distribution channel plays a critical role in ensuring the availability of these medications to patients[1].

Regulatory Environment

FDA Approvals

Regulatory approvals are crucial for the launch and success of generic drugs like Accuneb. For instance, Mylan N.V.’s Wixela Inhub received FDA approval, which significantly impacted the market[1].

Compliance and Standards

Companies must comply with stringent regulatory standards to ensure the quality and safety of their products. This compliance adds to the operational costs but is essential for market credibility[1].

Challenges and Opportunities

Challenges

The market faces challenges such as physician education, patient engagement, infrastructure, payer access, and reimbursement issues. These challenges can affect the adoption and sales of generic drugs like Accuneb[3].

Opportunities

The increasing demand for generic inhalation and nasal spray drugs presents significant opportunities for growth. The launch of new products and the expansion into new markets are key opportunities for companies in this sector[1].

Key Takeaways

• The global inhalation and nasal spray generic drugs market is growing rapidly, driven by new product launches and increasing demand.
• Accuneb, as a generic albuterol inhalation aerosol, benefits from this growth trend.
• North America is a dominant market due to high prevalence rates and new product launches.
• Strong financial health, including adequate cash reserves, is crucial for sustaining operations in this sector.
• Regulatory approvals and compliance are essential for market success.

FAQs

What is the projected growth rate of the inhalation and nasal spray generic drugs market?

The market is projected to grow at a CAGR of 8.56% from 2025 to 2030[1].

Which region dominates the inhalation and nasal spray generic drugs market?

North America dominates the market with a revenue share of over 35% in 2021[1].

What are the key drivers of the bronchodilators market?

The key drivers include the launch of new products, rising demand for generics, and the impact of COVID-19 on lung health[4].

How important are regulatory approvals for generic drugs like Accuneb?

Regulatory approvals are crucial for the launch and success of generic drugs, ensuring compliance with quality and safety standards[1].

What are the major challenges faced by the inhalation and nasal spray generic drugs market?

Challenges include physician education, patient engagement, infrastructure, payer access, and reimbursement issues[3].

Sources

1. Grand View Research: Inhalation And Nasal Spray Generic Drugs Market Report 2030.
2. Acumen Pharmaceuticals: Acumen Pharmaceuticals Reports Third Quarter 2024 Financial.
3. Investing.com: Earnings call: Acumen Pharmaceuticals reports on Q2 2024 progress.
4. Grand View Research: Bronchodilators Market Size & Trends Analysis Report, 2030.
5. Acumen Pharmaceuticals: Acumen Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Highlights.