ATENOLOL - Generic Drug Details

What are the generic drug sources for atenolol and what is the scope of patent protection?

Atenolol is the generic ingredient in five branded drugs marketed by Astrazeneca, Able, Apothecon, Aurobindo Pharma, Chartwell Rx, Esjay Pharma, Hlthcare, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, SCS, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Twi Pharms, Unichem, Unique, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Aurobindo Pharma Usa, Novitium Pharma, and Zydus Pharms, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-four drug master file entries for atenolol. Thirty-five suppliers are listed for this compound.

Summary for ATENOLOL

US Patents:	0
Tradenames:	5
Applicants:	26
NDAs:	42
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	118
Patent Applications:	5,642
Drug Prices:	Drug price trends for ATENOLOL
Drug Sales Revenues:	Drug sales revenues for ATENOLOL
What excipients (inactive ingredients) are in ATENOLOL?	ATENOLOL excipients list
DailyMed Link:	ATENOLOL at DailyMed

See drug prices for ATENOLOL

See drug sales revenues for ATENOLOL

Recent Clinical Trials for ATENOLOL

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

Sponsor	Phase
Zagazig University	Phase 2
Ain Shams University	Phase 4
MaineHealth	Phase 3

See all ATENOLOL clinical trials

Pharmacology for ATENOLOL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for ATENOLOL

Adrenergic beta-1 Receptor Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for ATENOLOL

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for ATENOLOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esjay Pharma	ATENOLOL	atenolol	TABLET;ORAL	073543-001	Dec 19, 1991		DISCN	No	No
Nostrum Labs	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	074404-002	May 14, 1998		DISCN	No	No
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	AB	RX	Yes	No
Aurobindo Pharma Usa	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	074203-002	Oct 31, 1993		DISCN	No	No
Esjay Pharma	ATENOLOL	atenolol	TABLET;ORAL	073542-001	Dec 19, 1991		DISCN	No	No
Able	ATENOLOL	atenolol	TABLET;ORAL	076907-003	Jul 30, 2004		DISCN	No	No

Expired US Patents for ATENOLOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,934,032
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	3,836,671
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,836,671
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,663,607
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,836,671
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,663,607

ATENOLOL Market Analysis and Financial Projection Experimental

Atenolol Market Dynamics and Financial Trajectory

Market Size and Growth

The atenolol market has experienced significant growth in recent years and is poised for continued expansion. As of 2023, the market size was valued at $11.05 billion, and it is expected to grow to $12.01 billion in 2024 at a compound annual growth rate (CAGR) of 8.7%[2][3][4].

By 2028, the market is projected to reach $15.85 billion, maintaining a CAGR of 7.2%. This robust growth is driven by several key factors, including increased demand for antihypertensive drugs, a larger patient pool with conditions such as arrhythmia and angina, and a rise in the prevalence of glaucoma and arrhythmia[2][3][4].

Drivers of Market Growth

Several factors are driving the growth of the atenolol market:

Increasing Prevalence of Hypertension and Cardiovascular Diseases (CVDs)

The rising prevalence of hypertension and CVDs is a significant driver. Hypertension affects an estimated 1.28 billion adults worldwide, according to the World Health Organization, and CVDs are on the rise due to aging demographics, various risk factors, and gaps in prevention and treatment strategies[1][3][4].

Growing Demand for Beta Blockers

There is a growing demand for beta blockers, particularly beta-1 selective blockers like atenolol. These drugs are crucial in managing hypertension, angina, and arrhythmias by reducing heart rate, lowering blood pressure, and alleviating symptoms[2][3][4].

Regulatory Approvals and New Formulations

Recent regulatory approvals for new formulations, including extended-release formulations, are also boosting market growth. These advancements enhance the efficacy and convenience of atenolol, making it more appealing to patients and healthcare providers[2][3][4].

Rising Demand for Combination Therapies

The increasing demand for combination therapies in treating cardiovascular conditions further supports market growth. Atenolol is often used in combination with other medications to manage complex cardiovascular diseases effectively[2][3][4].

Aging Population and Lifestyle Factors

A significant rise in the aging population and poor lifestyle and dietary habits leading to cardiovascular issues also contribute to the market's expansion. As the global population ages, the incidence of cardiovascular diseases increases, driving the demand for atenolol[1][3][4].

Market Segmentation

The atenolol market is segmented in several ways to understand its dynamics better:

By Form

The market is segmented by form into tablets, IV solutions, and other forms. Tablets are the most common form due to their ease of administration and widespread availability[3].

By Distribution Channel

The distribution channels include hospital pharmacies, drug stores, online pharmacies, and other channels. Online pharmacies have seen a significant rise in popularity, contributing to market growth[3].

By Application

Atenolol is used to treat various conditions, including hypertension, angina, arrhythmia, and other cardiovascular diseases. Hypertension is the primary application, given its high prevalence globally[3].

Regional Analysis

The atenolol market is analyzed regionally to identify key markets and growth opportunities:

Global Market Split

The global market is split by region, with significant markets in North America, Europe, Asia-Pacific, and other regions. Each region has its own growth trajectory based on local healthcare systems, population demographics, and economic factors[3].

Country-Specific Analysis

Country-specific analysis highlights the varying demand and growth rates in different countries. For instance, the acquisition of Teva Pharmaceutical Industries by Marksans Pharma in April 2023 is expected to expand manufacturing capacity in India and diversify the product portfolio, impacting regional market dynamics[1][4].

Competitive Landscape

The atenolol market is highly competitive, with several key players:

Major Companies

Companies like F. Hoffmann-La Roche Ltd., Teva Pharmaceutical Industries, and Marksans Pharma are major players in the market. These companies are involved in continuous research and development to improve formulations and expand their product portfolios[1][4].

Strategic Moves

Strategic acquisitions, such as Marksans Pharma's acquisition of Teva Pharmaceutical Industries, aim to enhance manufacturing capacity and diversify product offerings, further intensifying competition in the market[1][4].

Challenges and Opportunities

Despite the growth, the atenolol market faces several challenges and opportunities:

Impact of Global Events

The Russian-Ukraine war and higher inflation rates in many countries have impacted supply chains and consumption patterns, affecting the global market. However, these challenges also present opportunities for companies to adapt and innovate[4].

COVID-19 Impact

The continued but declining impact of COVID-19 on supply chains and consumption patterns has forced the industry to be more resilient and adaptable. This has led to increased investment in digital health solutions and online pharmacies, which are driving market growth[4].

Innovations and Trends

Several trends and innovations are shaping the atenolol market:

Extended-Release Formulations

The development of extended-release formulations is a significant trend. These formulations offer improved patient compliance and reduced dosing frequency, enhancing the overall treatment experience[2][3][4].

Transdermal Drug Delivery

Advancements in transdermal drug delivery technology are also noteworthy. For example, the atenolol transdermal gel market, though smaller, is expected to grow at a CAGR of 5.7% from 2023 to 2032, driven by the rising prevalence of cardiovascular diseases and technological advancements[5].

Key Takeaways

• The atenolol market is expected to grow from $11.05 billion in 2023 to $15.85 billion by 2028.
• Key drivers include the increasing prevalence of hypertension and CVDs, demand for beta blockers, regulatory approvals for new formulations, and a rising demand for combination therapies.
• The market is segmented by form, distribution channel, and application, with tablets and hypertension treatment being dominant.
• Regional analysis highlights significant markets in various regions, with strategic acquisitions and innovations shaping the competitive landscape.
• Challenges such as global events and COVID-19 have presented opportunities for adaptation and innovation.

Frequently Asked Questions

Q: What is the projected market size of atenolol by 2028? A: The atenolol market is expected to reach $15.85 billion by 2028[2][3][4].

Q: What are the primary drivers of the atenolol market growth? A: The primary drivers include the increasing prevalence of hypertension and CVDs, growing demand for beta blockers, recent regulatory approvals for new formulations, and a rising demand for combination therapies[2][3][4].

Q: How does the aging population impact the atenolol market? A: The aging population contributes to the market growth due to the increased incidence of cardiovascular diseases with age[1][3][4].

Q: What are the major trends in the atenolol market? A: Major trends include the demand for beta-1 selective blockers, recent regulatory approvals for new formulations, the development of extended-release formulations, and a rising demand for combination therapies[2][3][4].

Q: Which companies are key players in the atenolol market? A: Key players include F. Hoffmann-La Roche Ltd., Teva Pharmaceutical Industries, and Marksans Pharma[1][4].

Cited Sources

1. ResearchAndMarkets.com: Atenolol Global Market Size, Competitors, Trends & Forecast.
2. OpenPR: Atenolol Market Trends, Top Companies, Share, Growth.
3. GlobeNewswire: Atenolol Market Report 2024: Growing Demand for Beta-1 Selective Blockers.
4. GII Research: Atenolol Global Market Report 2024.
5. BusinessResearchInsights: Atenolol Transdermal Gel Market Share, Growth, Forecast, 2032.