ATENOLOL; CHLORTHALIDONE - Generic Drug Details

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

Atenolol; chlorthalidone is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Usa, Nostrum Labs, Novitium Pharma, Pliva, Sun Pharm Industries, Twi Pharms, Unichem, Watson Labs, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for ATENOLOL; CHLORTHALIDONE

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	11
Clinical Trials:	4
DailyMed Link:	ATENOLOL; CHLORTHALIDONE at DailyMed

Recent Clinical Trials for ATENOLOL; CHLORTHALIDONE

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

Sponsor	Phase
Federico II University	Phase 4
Agenzia Italiana del Farmaco	Phase 4
US Department of Veterans Affairs

See all ATENOLOL; CHLORTHALIDONE clinical trials

Pharmacology for ATENOLOL; CHLORTHALIDONE

Drug Class	Thiazide-like Diuretic beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for ATENOLOL; CHLORTHALIDONE

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

US Patents and Regulatory Information for ATENOLOL; CHLORTHALIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	073665-001	Jul 2, 1992	AB	RX	No	No
Unichem	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	213302-002	Nov 25, 2020	AB	RX	No	No
Nostrum Labs	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	074404-002	May 14, 1998		DISCN	No	No
Unichem	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	213302-001	Nov 25, 2020	AB	RX	No	No
Zydus Pharms	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	210028-002	Mar 8, 2019	AB	RX	No	No
Novitium Pharma	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	215560-001	Oct 25, 2021	AB	RX	No	No
Aurobindo Pharma Usa	ATENOLOL AND CHLORTHALIDONE	atenolol; chlorthalidone	TABLET;ORAL	074203-001	Oct 31, 1993		DISCN	No	No

Expired US Patents for ATENOLOL; CHLORTHALIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,836,671
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	3,663,607
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,934,032
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,663,607
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	3,934,032
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	3,836,671

ATENOLOL; CHLORTHALIDONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atenolol and Chlorthalidone

Introduction

Atenolol and chlorthalidone are widely used medications in the management of hypertension and other cardiovascular conditions. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global atenolol market is projected to experience significant growth over the next decade. As of 2023, the market size was valued at USD 11.59 billion and is expected to reach USD 22.97 billion by 2036, growing at a Compound Annual Growth Rate (CAGR) of approximately 5.4% during the forecast period of 2024-2036[1].

Key Drivers of Growth

Several factors are driving the growth of the atenolol market:

Increasing Prevalence of Hypertension

The worldwide prevalence of hypertension is a major driver. According to the World Health Organization (WHO), an estimated 1.28 billion people aged 30-79 years have hypertension globally, with two-thirds residing in low- and middle-income countries[1].

Aging Population

The significant rise in the aged population is another key factor. The global population of people aged 60 and above is projected to increase from 1 billion in 2020 to 1.4 billion by 2030 and further to 2.1 billion by 2050. Aged individuals are more prone to disorders such as hypertension, cardiac diseases, and diabetes[1].

Lifestyle Factors

Poor lifestyle and dietary habits among the population also contribute to the growing demand for antihypertensive drugs like atenolol[1].

Market Segmentation

The global atenolol market is segmented based on application and distribution channels.

Application Segmentation

• Hypertension: This segment is expected to gain the largest market share, approximately 55% by 2036, due to the increasing prevalence of hypertension and the expanding demand for antihypertensive drugs[1].
• Angina and Arrhythmia: These segments also contribute significantly to the market, driven by the rising incidence of cardiovascular diseases.

Distribution Channel Segmentation

• Hospital Pharmacies: This segment is expected to garner a significant share of around 49% by 2036, driven by the increasing patient pool in hospitals and the rise in cardiovascular disorders[1].
• Online Pharmacies: This segment is projected to witness an impressive CAGR due to the rising awareness and expanding penetration of the internet worldwide[1].

Regional Market Analysis

North America

The North American market is expected to hold the largest share, approximately 40% by 2036, driven by the high prevalence of cardiac diseases and hypertension in the region. For instance, in the U.S., 116 million individuals have hypertension, and hypertension-related deaths were significant in 2019[1].

Asia Pacific

The Asia Pacific region is the second largest market, expected to register a share of about 28% by 2036. The growth here is driven by the rising burden of hypertension, population surge, and changing lifestyles[1].

Europe

Europe also constitutes a significant portion of the global atenolol market, with growth driven by increasing healthcare expenditure and the availability of advanced treatments[1].

Financial Trajectory

The financial trajectory of atenolol is closely tied to its market growth. Here are some key financial highlights:

Market Value

• In 2023, the atenolol market was valued at USD 11.59 billion.
• By 2024, the market size is assessed at USD 12.15 billion.
• The market is expected to reach USD 22.97 billion by 2036[1].

Revenue from Antihypertensive Drugs

The worldwide revenue of antihypertensive drugs, including atenolol, is anticipated to boost significantly. For example, the revenue from antihypertensive drugs is expected to increase by around USD 24 billion by the end of 2023[1].

Combination Therapies

Atenolol is often used in combination with other drugs, such as chlorthalidone, to enhance its antihypertensive effects.

Atenolol and Chlorthalidone Combination

• The combination of atenolol and chlorthalidone, known as Tenoretic, provides a convenient formulation for concomitant administration. This combination has additive antihypertensive effects without interfering with the bioavailability of either drug[3].

Challenges and Opportunities

While the market for atenolol and chlorthalidone is growing, there are challenges and opportunities to consider:

Generic Competition

The entry of generic versions, such as Unichem Laboratories Limited's generic Atenolol and Chlorthalidone Tablets, can impact the market share of branded products[4].

Regulatory Changes

Changes in regulatory environments, such as the transfer of commercial rights by AstraZeneca to Atnahs Pharma, can also influence market dynamics[4].

Clinical Outcomes and Comparisons

Clinical trials have compared the efficacy of atenolol and chlorthalidone with other antihypertensive drugs.

ALLHAT Trial

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) compared chlorthalidone with other antihypertensive agents. The trial found that chlorthalidone was effective in reducing blood pressure and cardiovascular outcomes, although it had different effects in different racial subgroups[5].

Key Takeaways

• The global atenolol market is expected to grow significantly, driven by the increasing prevalence of hypertension and the aging population.
• The market is segmented by application and distribution channels, with hypertension and hospital pharmacies being key segments.
• Regional markets, particularly North America and Asia Pacific, are significant contributors to the global market.
• Combination therapies, such as atenolol and chlorthalidone, are popular due to their additive antihypertensive effects.
• Generic competition and regulatory changes can impact market dynamics.

FAQs

Q: What is the projected market size of atenolol by 2036? A: The global atenolol market is expected to reach USD 22.97 billion by 2036[1].

Q: What are the main drivers of the atenolol market growth? A: The main drivers include the increasing prevalence of hypertension, the aging population, and poor lifestyle and dietary habits[1].

Q: Which segment is expected to gain the largest market share in the atenolol market? A: The hypertension segment is expected to gain the largest market share, approximately 55% by 2036[1].

Q: How does the combination of atenolol and chlorthalidone work? A: The combination, known as Tenoretic, provides additive antihypertensive effects without interfering with the bioavailability of either drug[3].

Q: What are the regional markets that contribute significantly to the global atenolol market? A: North America and the Asia Pacific region are the significant contributors, with North America expected to hold the largest share by 2036[1].

Sources

1. Research Nester: Atenolol Market Size & Share, Growth Forecasts 2024-2036.
2. American Academy of Family Physicians: Managing Hypertension Using Combination Therapy.
3. FDA: TENORETIC® (atenolol and chlorthalidone) - accessdata.fda.gov.
4. Research Nester: Atenolol Market - Top Companies and Manufacturers.
5. JAMA Network: Outcomes in Hypertensive Black and Nonblack Patients Treated with Different Antihypertensive Regimens.