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. Ten 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 AIPING PHARM INC on May 31^st, 1990.

Summary for TENORETIC 50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	54
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
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984

International Patents for TENORETIC 50

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5037182
Austria	305249
Czechoslovakia	153065	ZPUSOB VYROBY FENOXYPROBANOLAMINU
Ireland	37458
Yugoslavia	34281
Netherlands	162363
France	2034561

Market Dynamics and Financial Trajectory for TENORETIC 50

Last updated: July 31, 2025

Introduction

TENORETIC 50, combining atenolol and chlorthalidone, is a well-established antihypertensive medication used worldwide. Its presence in the pharmaceutical market reflects its role in managing hypertension, a leading risk factor for cardiovascular diseases. Analyzing its market dynamics and financial trajectory entails understanding demand drivers, competitive landscape, regulatory factors, and pricing patterns, which together influence its commercial performance.

Market Overview

Hypertension remains a significant global health challenge, affecting over 1.3 billion individuals worldwide, with prevalence rising due to aging populations, urbanization, and lifestyle factors [1]. The growing burden of cardiovascular diseases sustains demand for effective antihypertensive therapies such as TENORETIC 50, which combines the beta-blocker atenolol and diuretic chlorthalidone for synergistic blood pressure control.

The global antihypertensive drug market was valued at approximately USD 21 billion in 2022, with an expected compound annual growth rate (CAGR) of around 4-5% over the next five years [2]. TENORETIC 50 occupies a substantial share in fixed-dose combination (FDC) antihypertensives, favored for improved patient adherence and simplified regimens.

Demand Drivers

Epidemiological Trends

Rising hypertension prevalence directly correlates with increased prescriptions of combination therapies like TENORETIC 50. Developed markets such as North America and Europe exhibit high penetration rates, whereas emerging economies demonstrate rapid growth driven by increased healthcare access and initiatives to combat non-communicable diseases.

Clinical Efficacy and Therapeutic Convenience

The combination of atenolol and chlorthalidone provides potent antihypertensive effects. Clinical guidelines increasingly favor fixed-dose combinations to enhance compliance, reduce pill burden, and improve control rates [3]. This shifts prescription patterns towards FDCs, bolstering demand for drugs like TENORETIC 50.

Prescriber and Patient Preferences

Physicians favor well-established, evidence-supported medications with proven safety profiles. The convenience of a single daily dose appeals to patients, reducing medication errors and discontinuation rates, which positively impacts sales volumes.

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Regulatory Environment

Regulatory agencies such as the FDA and EMA maintain rigorous approval standards. The official recognition of TENORETIC 50's efficacy and safety certifications facilitates market access. Additionally, patent expirations influence generic entry, affecting market share and pricing strategies.

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Competitive Landscape

The antihypertensive segment is crowded, with numerous branded and generic FDC offerings. Key competitors include products like Diovan HCT, Micardis HCT, and newer combination therapies with angiotensin receptor blockers (ARBs) and calcium channel blockers. Generics have significantly eroded branded market shares, leading to downward pressure on prices.

Generic manufacturers entering markets post-patent expiry have boosted affordability, expanding patient access. Market competition accelerates price declines, impacting revenue potential for branded formulations like TENORETIC 50.

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Pricing and Reimbursement Dynamics

Pricing strategies vary across regions. In saturated markets such as the US and EU, reimbursement policies heavily influence retail prices and patient out-of-pocket costs. Cost-containment efforts by healthcare systems prompt preference for generic equivalents, pressuring manufacturers to optimize margins and innovate.

Insurance coverage and formulary placements also dictate access, with formulary inclusion being crucial for sustained sales.

Financial Trajectory

Historical Revenue and Growth Patterns

Historically, TENORETIC 50, presuming it's a branded formulation, experienced steady sales driven by its efficacy and safety profile. However, entering generic markets post-patent expiry tends to reduce revenues dramatically, as observed in similar antihypertensive drugs. For instance, prior to patent expiry, branded sales generally contribute significantly, but with generics flooding the market, revenues often decline by 70-90%.

Post-Patent Era Expectations

The transition from patent-protected sales to generics typically results in revenue erosion but can be offset by increased volume sales owing to affordability and wider access. Companies that maintain manufacturing efficiencies or own multiple formulation patents may sustain margins. For TENORETIC 50, the key challenge is competing in a price-sensitive environment with numerous similar products.

Emerging Market Opportunities

Emerging markets present significant growth potential due to expanding healthcare infrastructure and increased awareness of hypertension management. Local manufacturers often produce lower-cost generics, increasing access and potentially boosting sales volumes for validated formulations like TENORETIC 50.

Impact of Regulatory and Policy Changes

Stringent pricing regulations in countries like India and Brazil may cap profits but promote broader access. Conversely, healthcare reforms emphasizing value-based care enhance the importance of demonstrated efficacy, which benefits established medications with proven outcomes.

Strategic Considerations

Manufacturers must adapt through strategies such as:

• Developing next-generation formulations or combination variants with improved pharmacokinetics.
• Engaging in patent extensions or obtaining new use patents.
• Investing in differentiated marketing emphasizing efficacy and safety.
• Building robust generic manufacturing capabilities to capture volume-driven revenue post-patent expiry.

Future Outlook

The future financial trajectory for TENORETIC 50 relies heavily on the following factors:

• Extent of patent protections and timing of generic entries.
• Adoption rates of fixed-dose combinations in target markets.
• Health policy shifts favoring cost-effective therapies.
• Competitive innovation and portfolio diversification.

Projected moderate growth in markets with favorable reimbursement policies and expanding hypertension prevalence suggests a resilient demand profile. However, intense pricing competition and patent expirations necessitate strategic agility to sustain profitability.

Key Takeaways

• Growing Disease Burden: Rising hypertension globally sustains demand for effective FDCs such as TENORETIC 50.
• Market Competition: The entry of generics has compressed pricing; success hinges on cost management and differentiation.
• Regulatory & Reimbursement Factors: Policy landscapes influence market access and profitability.
• Emerging Markets: Significant growth prospects owing to expanding healthcare infrastructure and higher disease prevalence.
• Innovation & Portfolio Strategy: Continuous R&D and patent management are vital to prolong revenue streams.

FAQs

1. What is the primary therapeutic advantage of TENORETIC 50?
   It offers a combined antihypertensive effect, improving patient adherence through a simplified dosing regimen, which enhances blood pressure control.

2. How does patent expiry impact TENORETIC 50’s market?
   Patent expiration typically leads to generic competition, resulting in significant revenue declines but increased accessibility and volume sales.

3. Which emerging markets are most promising for TENORETIC 50?
   Countries in Asia, Latin America, and Africa with rising hypertension prevalence and improving healthcare infrastructure present sizable growth opportunities.

4. What are the principal challenges facing TENORETIC 50’s commercialization?
   Intense pricing competition from generics, regulatory hurdles, and reimbursement policies pose significant challenges.

5. How do regulatory policies influence its market trajectory?
   Approval standards and pricing regulations can restrict or facilitate market access, impacting revenues and strategic planning.

References

[1] World Health Organization. Hypertension Fact Sheet. 2022.
[2] Grand View Research. Antihypertensive Drugs Market Analysis. 2022.
[3] American Heart Association. Guidelines for the Prevention, Detection, Evaluation, and Management of High Blood Pressure. 2021.