Albuterol - Generic Drug Details

What are the generic sources for albuterol and what is the scope of freedom to operate?

Albuterol is the generic ingredient in eighteen branded drugs marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Schering, Glaxosmithkline, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Norvium Bioscience, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Hibrow Hlthcare, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Aiping Pharm Inc, and Watson Labs Teva, and is included in one hundred and eight NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for albuterol. There is one tentative approval for this compound.

Summary for albuterol

US Patents:	35
Tradenames:	18
Applicants:	56
NDAs:	108
Drug Master File Entries:	38
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	287
Patent Applications:	6,615
Drug Prices:	Drug price trends for albuterol
Drug Sales Revenues:	Drug sales revenues for albuterol
What excipients (inactive ingredients) are in albuterol?	albuterol excipients list
DailyMed Link:	albuterol at DailyMed

See drug prices for albuterol

See drug sales revenues for albuterol

Recent Clinical Trials for albuterol

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

Sponsor	Phase
Johns Hopkins University	Phase 3
Parexel	Phase 3
Norwegian School of Sport Sciences	N/A

See all albuterol clinical trials

Generic filers with tentative approvals for ALBUTEROL

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for albuterol

Adrenergic beta-2 Receptor Agonists

Bronchodilator Agents

Tocolytic Agents

US Patents and Regulatory Information for albuterol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hibrow Hlthcare	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	213524-001	Oct 8, 2020		DISCN	No	No
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072780-001	Jun 25, 1993		DISCN	No	No
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983		DISCN	Yes	No

Expired US Patents for albuterol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	VENTOLIN	albuterol	AEROSOL, METERED;INHALATION	018473-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	VENTOLIN	albuterol	AEROSOL, METERED;INHALATION	018473-001	Approved Prior to Jan 1, 1982
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982

Albuterol Market Analysis and Financial Projection Experimental

Albuterol Market Dynamics and Financial Trajectory

Introduction

Albuterol, a widely used bronchodilator, is crucial in the management of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). The market for albuterol is driven by several key factors, including increasing prevalence of respiratory diseases, advancements in drug delivery systems, and regulatory environments.

Market Size and Growth

The global albuterol market is projected to experience significant growth over the coming years. As of 2022, the market was valued at USD 4,587.68 million and is expected to reach USD 7,984.37 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.80% during the forecast period[1][4].

Drivers of Market Growth

Increasing Prevalence of Respiratory Diseases

The rising global prevalence of asthma, COPD, and other respiratory diseases is a major driver for the albuterol market. With over 235 million people suffering from asthma and more than 250 million from COPD worldwide, the demand for effective treatments like albuterol is on the rise[1][4].

Growing Awareness and Diagnosis

Improved awareness and diagnostic capabilities have led to earlier detection and better management of respiratory conditions. This increased diagnosis rate contributes to a higher demand for albuterol medications[1].

Lifestyle Changes

Modern lifestyles, characterized by sedentary habits, poor diet, and exposure to environmental pollutants, exacerbate respiratory diseases. Factors like smoking, occupational hazards, and urbanization increase the risk of these conditions, further driving the demand for albuterol[1].

Government Initiatives and Healthcare Expenditure

Government and healthcare organizations' initiatives to address respiratory diseases through awareness campaigns, research support, and healthcare budget allocations also boost the market. These efforts enhance access to albuterol medications, contributing to market growth[1].

Opportunities in the Market

Combination Therapies

Combination therapies that include albuterol along with other medications, such as corticosteroids or long-acting bronchodilators, offer significant opportunities. These therapies provide enhanced efficacy, convenience, and simplified treatment regimens, attracting both healthcare providers and patients[1].

Innovations in Drug Delivery Systems

Advancements in drug delivery systems, such as smart inhalers equipped with digital technology, are enhancing the efficiency and effectiveness of albuterol administration. These innovations help patients track their usage and improve adherence to treatment protocols[4].

Regional Analysis

North America

North America dominates the albuterol market due to a strong healthcare infrastructure, a high prevalence of respiratory diseases, and significant research activities in the region. The U.S., Canada, and Mexico are key markets in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to witness significant growth due to government initiatives to promote awareness, rising medical tourism, growing research activities, and a large population pool. Countries like China, Japan, India, and South Korea are driving this growth[1].

Competitive Landscape

Market Competition

The albuterol market is highly competitive, with pharmaceutical companies competing on product efficacy and innovative delivery systems. The rise of generic alternatives has made the market more accessible, but brand-name products with unique delivery methods continue to thrive[4].

Challenges Faced by Key Players

Companies like Cipla face multiple challenges, including supply constraints, regulatory delays, and increasing competition. For instance, Cipla's respiratory drug Advair faces delays in its launch due to regulatory challenges, and albuterol itself is facing increased competition[2].

Financial Trajectory

Market Value and Growth Rate

The albuterol market's financial trajectory is marked by a steady growth rate. With a projected CAGR of 6.80% from 2022 to 2030, the market is expected to more than double in value during this period[1].

Revenue Forecast

The U.S. asthma drugs market, which includes albuterol, is valued at USD 9.41 billion in 2024 and is projected to reach USD 14.75 billion by 2033, growing at a CAGR of 5.12%[3].

Impact of Regulatory and Competitive Factors

Regulatory challenges and competitive pressures can impact the financial performance of companies in the albuterol market. For example, delays in regulatory approvals and supply constraints can affect revenue projections. However, companies that adapt to these challenges can find lucrative opportunities in emerging markets[2][4].

Key Takeaways

• The global albuterol market is expected to grow significantly, driven by the increasing prevalence of respiratory diseases and advancements in drug delivery systems.
• North America and the Asia-Pacific region are key markets, with the latter expected to witness significant growth.
• Combination therapies and innovative drug delivery systems offer substantial opportunities for market expansion.
• Regulatory challenges and competitive pressures are critical factors that companies must navigate to maintain market share.
• The market's financial trajectory is robust, with a projected CAGR of 6.80% from 2022 to 2030.

FAQs

What is the current market size of the global albuterol market?

The global albuterol market was valued at USD 4,587.68 million in 2022[1].

What is the projected growth rate of the albuterol market from 2022 to 2030?

The albuterol market is expected to grow at a CAGR of 6.80% from 2022 to 2030[1].

Which regions dominate the albuterol market?

North America currently dominates the albuterol market, while the Asia-Pacific region is expected to witness significant growth during the forecast period[1].

What are the key drivers of the albuterol market?

Key drivers include the increasing prevalence of respiratory diseases, growing awareness and diagnosis, lifestyle changes, and government initiatives and healthcare expenditure[1].

How are innovations in drug delivery systems impacting the albuterol market?

Innovations such as smart inhalers with digital technology are enhancing the efficiency and effectiveness of albuterol administration, improving patient adherence and treatment outcomes[4].

What challenges are companies like Cipla facing in the albuterol market?

Companies like Cipla are facing supply constraints, regulatory delays, and increasing competition, which can impact their financial performance and market share[2].

Sources

1. Data Bridge Market Research: Global Albuterol Market – Industry Trends and Forecast to 2030.
2. MoneyControl: Multiple near-term challenges may hijack Cipla's growth trajectory.
3. NovaOne Advisor: U.S. Asthma Drugs Market Size, Share & Growth Report, 2033.
4. Market Research Intellect: Albuterol Market Size And Projection - Market Research Intellect.