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Last Updated: December 28, 2025

ATENOLOL AND CHLORTHALIDONE Drug Patent Profile


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Which patents cover Atenolol And Chlorthalidone, and when can generic versions of Atenolol And Chlorthalidone launch?

Atenolol And Chlorthalidone is a drug marketed by Aiping Pharm Inc, Aurobindo Pharma Usa, Nostrum Labs, Novitium Pharma, Pliva, Sun Pharm Industries, Unichem, Watson Labs, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in ATENOLOL AND CHLORTHALIDONE 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 Atenolol And Chlorthalidone

A generic version of ATENOLOL AND CHLORTHALIDONE was approved as atenolol; chlorthalidone by AIPING PHARM INC on May 31st, 1990.

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Summary for ATENOLOL AND CHLORTHALIDONE
Drug patent expirations by year for ATENOLOL AND CHLORTHALIDONE
Recent Clinical Trials for ATENOLOL AND CHLORTHALIDONE

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

SponsorPhase
Federico II UniversityPhase 4
Agenzia Italiana del FarmacoPhase 4
VA Office of Research and Development

See all ATENOLOL AND CHLORTHALIDONE clinical trials

Pharmacology for ATENOLOL AND CHLORTHALIDONE

US Patents and Regulatory Information for ATENOLOL AND CHLORTHALIDONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aiping Pharm Inc ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 072302-002 May 31, 1990 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Zydus Pharms ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 210028-002 Mar 8, 2019 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Novitium Pharma ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 215560-001 Oct 25, 2021 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Atenolol and Chlorthalidone

Last updated: July 30, 2025


Introduction

Atenolol and chlorthalidone are longstanding medications within cardiovascular therapeutics, addressing hypertension and related cardiovascular risks. Their market dynamics are shaped by evolving clinical guidelines, patent statuses, generic competition, and emerging treatment alternatives. This analysis provides an in-depth overview of the current landscape and projected financial trajectories of these drugs, essential for stakeholders and business decision-makers.


Historical Background and Pharmacological Significance

Atenolol, a beta-adrenergic blocker introduced in the late 1970s, has historically been employed for hypertension, ischemic heart disease, and arrhythmias. Its selectivity for β1-adrenergic receptors confers cardiovascular benefits with a relatively safe profile, making it a staple in antihypertensive regimens.

Chlorthalidone, a thiazide-like diuretic discovered earlier, gained prominence for effective blood pressure reduction and cardiovascular risk mitigation, especially among hypertensive patients at high risk of stroke or myocardial infarction. Its long half-life and sustained antihypertensive effect distinguish it from other diuretics like hydrochlorothiazide.


Market Dynamics

1. Patent Expiry and Generics Proliferation

Patent expirations have precipitated increased generic entry. Atenolol's patent expiry around 2006 facilitated widespread availability of low-cost generics, significantly compressing its profit margins. Similarly, chlorthalidone faced patent expiration in the early 2000s, although its market presence persisted mainly due to clinical preference and formulary positioning.

According to IMS Health data, generics now dominate the atenolol market, accounting for approximately 90% of prescriptions in major markets like the U.S. and EU. For chlorthalidone, generic formulations have materialized, but its prescription volume remains relatively stable owing to clinical inertia and guideline adherence.

2. Clinical Guideline Influence and Shifts

Recent guidelines influence formulary choices and prescribing patterns. The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend thiazide-type diuretics as first-line agents for uncomplicated hypertension, influencing increased chlorthalidone prescriptions over alternatives like atenolol which is now less favored due to data questioning its efficacy and safety [1].

Conversely, atenolol's usage declined after studies revealed limited benefit for certain populations and increased adverse events with long-term use, especially in the elderly. This has caused a market contraction, reducing revenue streams for branded versions.

3. Emerging Therapeutics and Competition

The hypertension treatment landscape has diversified, with calcium channel blockers, ACE inhibitors, ARBs, and novel agents like SGLT2 inhibitors gaining prominence. While these compounds offer superior profiles in specific patient subsets, generic atenolol and chlorthalidone maintain niche roles due to cost-effectiveness.

Innovative drugs encroach on traditional diuretic and beta-blocker markets, leading to a gradual decline in revenue from older, off-patent medications.

4. Regional Market Variations

In emerging markets, especially India and China, atenolol and chlorthalidone maintain significant market shares due to affordability and established clinical protocols. The global hypertensive population growth amplifies demand in these regions, sustaining revenue streams despite global declines.


Financial Trajectory

1. Revenue Trends and Forecasts

  • Atenolol: Historically a blockbuster, its revenue has sharply declined over the past decade due to declining prescriptions and intensified generic competition. Industry estimates project a compound annual decline rate (CAGR) of approximately -8% from 2021 to 2027 [2].

  • Chlorthalidone: Exhibiting steady yet moderate revenue, primarily driven by institutional formularies and chronic disease management programs. CAGR estimates suggest a -2% to -3% decline** over the same period, with potential stabilization owing to its role in combination therapies [3].

2. Pricing and Market Share Dynamics

Pricing for both drugs has fallen sharply since patent expiration. Average retail prices for atenolol generics decreased by over 60% in North America between 2010–2022. Chlorthalidone’s price decline has been more gradual, reflecting its niche positioning.

Market share shifts favor drugs with superior efficacy or safety profiles. As evidence has demonstrated limited benefit of atenolol in certain populations, utilization remains concentrated among specific cohorts, such as patients contraindicated for other antihypertensives.

3. Impact of Regulatory and Policy Changes

Health authorities’ emphasis on cost-effectiveness and evidence-based prescribing has further marginalized atenolol's use. Some countries have issued guidelines discouraging its routine use in favor of other agents. This regulatory landscape influences the financial prospects, primarily constraining revenue growth for associated manufacturers.


Potential Future Outlook

The future of atenolol and chlorthalidone hinges on several intersecting factors:

  • Continued decline in atenolol use, driven by emerging evidence and guideline reinforcement, suggests a further erosion of market share and revenues.

  • Chlorthalidone may sustain modest demand due to its proven efficacy in hypertension management and role in combination therapy, especially in resource-constrained settings.

  • Innovative formulations or biosimilars could offer marginal revenue opportunities but are unlikely to reverse declining trends significantly.

  • Market consolidation and patent challenges in the generics space could influence pricing and profitability, particularly for chlorthalidone, which remains a low-cost staple.


Strategic Implications for Industry Stakeholders

  • Pharmaceutical companies focused on longstanding antihypertensives should consider diversifying portfolios to include newer agents and combination therapies with broader efficacy profiles.

  • Investors should interpret declining revenue streams with caution, emphasizing pipeline development and potential in niche markets or regional growth areas.

  • Healthcare policymakers might further incentivize evidence-based prescribing, accelerating decline in the use of older, less effective drugs like atenolol.


Key Takeaways

  • Patent expirations and clinical guideline shifts have precipitated a significant decline in atenolol’s market, with generic competition dominating its landscape; revenues are projected to decline at a CAGR of approximately -8% through 2027.

  • Chlorthalidone, while more stable, faces a gradual reduction in market share, with a projected CAGR of -2% to -3%, primarily driven by its clinical efficacy and use in hypertension management.

  • Emerging antihypertensive agents and changing prescribing paradigms threaten the profitability of traditional therapies, requiring industry players to adapt strategically.

  • Regional variations offer some opportunities, especially in emerging markets where affordability sustains demand, yet global trends favor newer, evidence-based agents.

  • Long-term prospects for both drugs are limited unless they are integrated into combination therapies or repurposed for broader indications.


FAQs

1. What factors contributed to the decline of atenolol's market share?
Clinical evidence questioned its efficacy compared to other beta-blockers and antihypertensives, alongside safety concerns in certain populations, leading clinicians to prefer alternatives like bisoprolol or metoprolol. Regulatory updates and guideline shifts further discouraged its use.

2. Is chlorthalidone a better choice than hydrochlorothiazide?
Yes. Multiple studies demonstrate chlorthalidone's superior efficacy and longer half-life, providing sustained blood pressure control and reducing stroke risk more effectively in some populations [1].

3. How do patent expirations impact the profitability of these drugs?
Patent expiry allows generic manufacturers to enter the market, significantly reducing prices and profit margins for brand-name versions, often leading to industry revenue declines.

4. Are there innovative formulations or new indications for atenolol or chlorthalidone?
Currently, no significant novel formulations or new therapeutic indications are under development. Focus shifts toward newer agents with better safety and efficacy profiles.

5. What regional factors influence the demand for these drugs?
In emerging markets, cost-effective generics sustain demand; in developed countries, shifting guidelines and a focus on newer drugs reduce their prevalence.


References

[1] Whelton, P. K., et al. "2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults." Journal of the American College of Cardiology, 71(19), 2018.

[2] IQVIA. "Global Prescription Market Analysis," 2022.

[3] IMS Health Data. "Hypertension Medication Market Trends," 2022.

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