TENORETIC 50 Drug Patent Profile

When do Tenoretic 50 patents expire, and when can generic versions of Tenoretic 50 launch?

Tenoretic 50 is a drug marketed by Twi Pharms and is included in one NDA.

The generic ingredient in TENORETIC 50 is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tenoretic 50

A generic version of TENORETIC 50 was approved as atenolol; chlorthalidone by TWI PHARMS on May 31^st, 1990.

Summary for TENORETIC 50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
DailyMed Link:	TENORETIC 50 at DailyMed

Pharmacology for TENORETIC 50

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

US Patents and Regulatory Information for TENORETIC 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	AB	RX	Yes	No

Expired US Patents for TENORETIC 50

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	3,663,607
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	3,836,671

International Patents for TENORETIC 50

See the table below for patents covering TENORETIC 50 around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	553747	VERFAHREN ZUR HERSTELLUNG VON ALKANOLAMINDERIVATEN.
Yugoslavia	193575
U.S.S.R.	452091
Yugoslavia	193375
Switzerland	547257	VERFAHREN ZUR HERSTELLUNG VON ALKANOLAMINDERIVATEN.
Austria	305245

TENORETIC 50 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TENORETIC 50

Overview of TENORETIC 50

TENORETIC 50, a combination drug comprising atenolol and chlorthalidone, is widely used for the treatment of hypertension. This fixed-dose combination leverages the antihypertensive properties of both a beta 1-selective blocker (atenolol) and a monosulfonamyl diuretic (chlorthalidone)[3].

Market Size and Growth

The global atenolol market, which includes TENORETIC 50, is projected to experience significant growth. As of 2023, the atenolol market 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 Market Growth

Increasing Prevalence of Hypertension

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

Aging Population

The significant increase in the aged population also contributes to market growth. The global population of people aged 60 and above is projected to surge from 1 billion in 2020 to 1.4 billion by 2030 and further to 2.1 billion by 2050. Older individuals are more prone to hypertension and other cardiovascular diseases[1].

Lifestyle Factors

Poor lifestyle and dietary habits among the population are additional factors fueling the market growth. The increasing consumption of fast food and inappropriate diet habits are linked to higher rates of hypertension and cardiovascular diseases[1].

Regional Market Dynamics

North American Market

The North American market is expected to hold the largest share of the atenolol market, with approximately 40% by the end of 2036. This is due to 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 Market

The Asia Pacific region is projected to be the second largest market, with a share of about 28% by 2036. The growth here is driven by the rising burden of hypertension, increasing population, and changing lifestyle habits[1].

European Market

Europe is expected to hold a noteworthy share of about 17% by 2036. The region has seen a sharp increase in cardiovascular diseases, with over 1.6 million deaths in the European Union attributed to these conditions annually[1].

Financial Considerations

Sales and Revenue

In 2018, TENORETIC, along with other hypertension medicines like Inderal, Tenormin, Zestril, and Zestoretic, generated annual sales of $132 million in the markets covered by AstraZeneca's divestment agreement[4].

Divestment and Manufacturing

AstraZeneca divested the global commercial rights for these medicines to Atnahs Pharma in 2020, ensuring continued availability to patients. Atnahs made an upfront payment of $350 million to AstraZeneca and may also make future sales-contingent payments up to $40 million between 2020 and 2022[4].

Pricing and Accessibility

Cost of TENORETIC 50

The cost for TENORETIC 50 (50 mg-25 mg) oral tablets can vary, but for cash-paying customers, it is around $1,147 for a supply of 90 tablets. Generic versions are available at significantly lower prices, such as $26.45 for 30 tablets[5].

Patient Assistance Programs

Patient assistance programs (PAPs) and copay cards are available to help individuals with low income or those who are uninsured or under-insured. These programs offer cost-free or discounted medicines, making TENORETIC 50 more accessible to a broader patient base[5].

Competitive Landscape

Generic Versions

The availability of generic versions of atenolol and chlorthalidone tablets has increased competition in the market. Companies like Unichem Laboratories Limited have obtained ANDA authorization for their generic versions, which can be sold at lower prices compared to the branded versions[1].

Challenges and Opportunities

Regulatory and Healthcare Environment

The market is influenced by regulatory clearances and healthcare policies. For instance, the divestment of commercial rights by AstraZeneca to Atnahs Pharma was subject to customary closing conditions and regulatory clearances[4].

Patient Awareness and Education

Increasing awareness about hypertension and the importance of antihypertensive drugs is a significant opportunity for market growth. Educational campaigns and healthcare initiatives can drive demand for drugs like TENORETIC 50[1].

Key Takeaways

• The global atenolol market, including TENORETIC 50, is expected to grow significantly due to increasing hypertension prevalence and an aging population.
• Regional markets, particularly North America, Asia Pacific, and Europe, will drive this growth.
• Financial considerations include divestments, manufacturing agreements, and pricing strategies.
• Patient assistance programs and generic versions enhance the accessibility of TENORETIC 50.
• Regulatory and healthcare environments play crucial roles in market dynamics.

FAQs

What is TENORETIC 50 used for?

TENORETIC 50 is used for the treatment of hypertension, combining the antihypertensive effects of atenolol and chlorthalidone[3].

What is the projected market size of the atenolol market by 2036?

The atenolol market is expected to reach USD 22.97 billion by 2036, growing at a CAGR of approximately 5.4% during the forecast period[1].

Which regions are expected to dominate the atenolol market?

North America is expected to hold the largest share, followed by the Asia Pacific and European regions[1].

How much does TENORETIC 50 cost?

The cost for TENORETIC 50 (50 mg-25 mg) oral tablets can be around $1,147 for a supply of 90 tablets, with generic versions available at lower prices[5].

Are patient assistance programs available for TENORETIC 50?

Yes, patient assistance programs and copay cards are available to help make TENORETIC 50 more accessible to patients with low income or those who are uninsured or under-insured[5].

What was the outcome of AstraZeneca's divestment of hypertension medicines?

AstraZeneca divested the global commercial rights for hypertension medicines, including TENORETIC, to Atnahs Pharma, ensuring continued availability and generating significant upfront and potential future payments[4].

Sources

1. Research Nester: Atenolol Market Size & Share, Growth Forecasts 2024-2036
2. FDA: Tenoretic (atenolol/chlorothalidone) 50 mg / 25 mg
3. FDA: TENORETIC® (atenolol and chlorthalidone)
4. AstraZeneca: AstraZeneca divests rights to established hypertension medicines
5. Drugs.com: Tenoretic 50 Prices, Coupons, Copay Cards & Patient Assistance