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Last Updated: March 26, 2026

ATENOLOL Drug Patent Profile


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When do Atenolol patents expire, and what generic alternatives are available?

Atenolol is a drug marketed by Able, Aiping Pharm Inc, Apothecon, Aurobindo Pharma, Chartwell Rx, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Novitium Pharma, Pharmobedient, Pliva, SCS, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Unichem, Unique, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Aurobindo Pharma Usa, and Zydus Pharms. and is included in thirty-nine NDAs.

The generic ingredient in ATENOLOL 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

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

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Drug patent expirations by year for ATENOLOL
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Drug Sales Revenue Trends for ATENOLOL

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Recent Clinical Trials for ATENOLOL

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SponsorPhase
Department of Cardiology, Gdstrup Hospital, Herning, DenmarkPHASE2
Gdstrup HospitalPHASE2
VZW Cardiovascular Research Center AalstPHASE4

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Pharmacology for ATENOLOL

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
Pliva ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 074107-001 Sep 24, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Inds Inc ATENOLOL atenolol TABLET;ORAL 078210-002 Jul 10, 2007 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient ATENOLOL atenolol TABLET;ORAL 073026-002 May 1, 1992 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Atenolol: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Atenolol, a beta-blocker widely prescribed for hypertension and cardiovascular conditions, faces a mature market characterized by generic competition and a steady, albeit declining, revenue stream. Patent expiries for its innovator formulations have led to extensive generic penetration, driving down prices and limiting significant growth prospects. While therapeutic value remains, new entrants and evolving treatment protocols present ongoing challenges.

What is Atenolol's Current Market Share and Competitive Landscape?

Atenolol's market is dominated by generic manufacturers. The innovator drug, Tenormin, developed by AstraZeneca, lost patent protection decades ago, opening the door for numerous generic versions. This has resulted in a highly fragmented market with significant price competition.

  • Generic Dominance: Over 90% of atenolol prescriptions are filled by generic products. This is a direct consequence of expired patents and the well-established manufacturing processes for the drug.
  • Key Manufacturers: Major generic pharmaceutical companies, including Teva Pharmaceuticals, Mylan N.V. (now Viatris), and Sandoz (a Novartis company), are significant players in the atenolol market. Numerous smaller regional manufacturers also contribute to the supply.
  • Therapeutic Class: Atenolol belongs to the beta-adrenergic blocking agents class. It competes indirectly with other beta-blockers (e.g., metoprolol, carvedilol, propranolol) and other antihypertensive drug classes (e.g., ACE inhibitors, ARBs, calcium channel blockers, diuretics).
  • Pricing: Generic atenolol is available at very low price points, often measured in cents per dose. This low cost makes it an attractive option for cost-sensitive healthcare systems and patients, but it also limits overall market value.

What is the Historical Financial Performance of Atenolol?

The financial trajectory of atenolol has been characterized by a significant decline in revenue since the peak sales of its branded innovator versions.

  • Innovator Peak: Tenormin achieved peak annual sales exceeding $1 billion in the late 1990s and early 2000s. This period reflects its patent-protected status and widespread adoption.
  • Post-Patent Decline: Following patent expiry, sales of branded Tenormin plummeted as generic competition entered the market.
  • Current Revenue: The global market for atenolol, primarily driven by generic sales, is estimated to be in the low hundreds of millions of dollars annually. Precise figures are difficult to ascertain due to the highly fragmented generic market and the absence of centralized reporting for individual generic drugs. However, industry analyses place the total market value for atenolol significantly below its historical branded peaks.
  • Volume vs. Value: While prescription volumes for atenolol remain substantial due to its accessibility and affordability, the low per-unit price means that the total market value is constrained.

What are the Key Patents and Patent Expiry Dates Associated with Atenolol?

The patent landscape for atenolol is largely historical, with all primary patents for the original composition of matter and key formulations having expired.

  • Original Composition of Matter Patent: The foundational patents covering atenolol as a chemical entity expired decades ago. For instance, the original US patent for atenolol was granted in the early 1970s and expired in the early 1990s.
  • Formulation and Method of Use Patents: While secondary patents related to specific formulations, delivery methods, or novel uses may have existed, these too have largely expired or are no longer commercially significant for new market entrants.
  • Impact of Expiry: The expiration of these core patents enabled widespread generic manufacturing, leading to the current market structure. There are no significant active patents that would grant market exclusivity for the primary indications of atenolol.

What is the Regulatory Status and Clinical Utility of Atenolol?

Atenolol is an established medication with a well-defined regulatory status and a continued, albeit evolving, role in clinical practice.

  • FDA Approval: Atenolol is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension and angina pectoris.
  • WHO Model List: It is listed on the World Health Organization (WHO) Model List of Essential Medicines, highlighting its importance in global public health due to its efficacy and affordability.
  • Clinical Guidelines: Atenolol is frequently recommended in clinical practice guidelines for hypertension and post-myocardial infarction. However, newer beta-blockers and other antihypertensive classes are often preferred for their more favorable side effect profiles or specific therapeutic advantages in certain patient populations.
  • Therapeutic Profile: Atenolol is a cardioselective beta-1 adrenergic receptor antagonist. It reduces heart rate, myocardial contractility, and blood pressure.
  • Limitations: Its use can be associated with side effects such as fatigue, bradycardia, and cold extremities. In some guidelines, other beta-blockers are favored due to superior cardiovascular outcomes or reduced respiratory side effects.

What are the Future Market Projections and Growth Opportunities for Atenolol?

The future market for atenolol is projected to remain stable to slightly declining. Significant growth is unlikely due to its generic status and competitive pressures.

  • Projected Trajectory: The market is expected to experience a gradual decline in value, driven by ongoing price erosion among generic manufacturers and the increasing adoption of newer, branded medications with perceived superior efficacy or safety profiles.
  • Sustaining Demand: Demand will persist due to atenolol's low cost, which makes it a critical treatment option in resource-limited settings and for price-sensitive patient populations.
  • Limited Innovation: The absence of patent protection and the low profit margins associated with generic atenolol disincentivize significant R&D investment for new formulations or indications.
  • Niche Opportunities: Potential for minor growth could arise from specific market segments or geographic regions where cost is the primary driver of treatment decisions, or where access to newer agents is limited. Contract manufacturing opportunities for large generic players may offer steady, albeit low-margin, revenue.
  • Competition from Newer Agents: The development of newer antihypertensive and cardiovascular drugs with improved efficacy, safety profiles, or novel mechanisms of action will continue to siphon market share from older, off-patent medications like atenolol.

What are the Manufacturing and Supply Chain Considerations for Atenolol?

The manufacturing and supply chain for atenolol are characterized by high-volume, low-cost production models typical of generic pharmaceuticals.

  • Global Manufacturing Base: Production is spread across numerous facilities globally, with significant manufacturing capacity located in India and China, known for their cost-effective Active Pharmaceutical Ingredient (API) and finished dosage form production.
  • Generic Supply Chains: The supply chain is robust but highly competitive. Generic manufacturers operate on thin margins, necessitating efficient production processes and procurement of raw materials at competitive prices.
  • Quality Control: Regulatory bodies worldwide maintain stringent quality control standards for API and finished product manufacturing, including good manufacturing practices (GMP). Manufacturers must adhere to these standards to ensure product safety and efficacy.
  • API Sourcing: The availability and cost of atenolol API are critical factors influencing the profitability of generic manufacturers. Supply disruptions or significant price fluctuations in API can impact market stability.
  • Distribution Networks: Atenolol is distributed through established pharmaceutical wholesale channels to pharmacies, hospitals, and healthcare providers globally.

Key Takeaways

Atenolol operates within a mature, price-sensitive market dominated by generic competition. Its revenue potential is significantly constrained by decades-old patent expiries, leading to low per-unit pricing. While its therapeutic utility and status as an essential medicine ensure continued demand, especially in cost-conscious markets, growth prospects are minimal. Future market trajectory is projected to be stable to slightly declining, with limited scope for innovation or significant profit generation from new product development. Manufacturing is globalized and cost-driven, relying on efficient supply chains for API and finished products.

Frequently Asked Questions

  1. What is the primary driver of atenolol's low market value? The primary driver is the extensive generic competition that emerged following the expiration of its original composition of matter and formulation patents.

  2. Are there any active patents that could impact future atenolol market exclusivity? As of current data, there are no significant active patents that grant market exclusivity for the primary uses of atenolol. The patent landscape is largely historical.

  3. Can atenolol be considered a growth market for pharmaceutical investment? No, atenolol is not considered a growth market. Its revenue is stable to declining, and profit margins are very thin due to generic pricing.

  4. How does atenolol compete with other beta-blockers and antihypertensive drugs? Atenolol competes primarily on cost. Newer agents may offer perceived advantages in efficacy, safety profiles, or specific patient sub-populations, leading to preference in certain treatment algorithms.

  5. What is the typical manufacturing cost for generic atenolol? Manufacturing costs for generic atenolol are exceptionally low, contributing to its affordability. Specific cost figures are proprietary to individual manufacturers but are generally in the range of cents per pill for finished dosage forms.

Citations

[1] World Health Organization. (2023). World Health Organization Model List of Essential Medicines. Retrieved from https://www.who.int/publications/i/item/WHO-MVP-2023.01 [2] Food and Drug Administration. (n.d.). Drug Approvals and Databases. U.S. Department of Health and Human Services. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases [3] Pharmaceutical industry market research reports (various, e.g., IQVIA, Evaluate Pharma). (Data aggregated from multiple industry sources for market size and trends).

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