TENORMIN Drug Patent Profile

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

Tenormin is a drug marketed by Astrazeneca and Twi Pharms and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tenormin

A generic version of TENORMIN was approved as atenolol by AIPING PHARM INC on July 15^th, 1988.

Summary for TENORMIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	16
Patent Applications:	5,573
Drug Prices:	Drug price information for TENORMIN
What excipients (inactive ingredients) are in TENORMIN?	TENORMIN excipients list
DailyMed Link:	TENORMIN at DailyMed

See drug prices for TENORMIN

Recent Clinical Trials for TENORMIN

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

Sponsor	Phase
University of Tennessee Medical Center	Early Phase 1
High Risk Obstetrical Consultants	Early Phase 1
University of Tennessee Graduate School of Medicine	Early Phase 1

See all TENORMIN clinical trials

Pharmacology for TENORMIN

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for TENORMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	TENORMIN	atenolol	INJECTABLE;INJECTION	019058-001	Sep 13, 1989		DISCN	Yes	No
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	AB	RX	Yes	No
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for TENORMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,836,671
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	3,836,671
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,934,032
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,663,607
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,836,671
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,934,032

International Patents for TENORMIN

See the table below for patents covering TENORMIN around the world.

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

Market Dynamics and Financial Trajectory for TENORMIN (atenolol)

Last updated: November 1, 2025

Introduction

TENORMIN, an established beta-adrenergic blocker, is primarily used in managing hypertension, angina pectoris, and certain arrhythmias. With a history spanning over four decades, TENORMIN’s market presence and financial trajectory are shaped by evolving regulatory landscapes, technological innovations, demographic trends, and competitive dynamics within the cardiovascular therapeutic segment. This report delves into the key market forces influencing TENORMIN's continued relevance and future financial prospects, providing insights for stakeholders and industry analysts.

Historical Context and Drug Profile

Atenolol, marketed under TENORMIN by AstraZeneca (now part of AstraZeneca PLC), was introduced in the late 1970s and became a cornerstone therapy for cardiovascular conditions globally. Its proven efficacy in lowering blood pressure and reducing cardiac workload contributed significantly to its widespread adoption. Being a once-daily oral medication with a well-characterized safety profile, TENORMIN became a preferred choice for clinicians.

Despite its longstanding reputation, recent clinical debates and regulatory reviews have altered the market landscape, impacting its growth trajectory.

Market Dynamics

1. Regulatory and Clinical Shifts

In recent years, regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have scrutinized atenolol's comparative effectiveness. Numerous meta-analyses suggest that atenolol may offer less cardiovascular protection than newer agents like bisoprolol or nebivolol, especially concerning stroke prevention [1]. Additionally, concerns over adverse metabolic profiles, such as increased risk of diabetes mellitus, have prompted re-evaluation of atenolol's positioning.

This has led to a decline in prescriptive preference for TENORMIN in some regions, primarily in North America and Western Europe.

2. Competitive Landscape

The global antihypertensive market has evolved with the advent of combination therapies and novel drug classes, including angiotensin receptor blockers, calcium channel blockers, and direct vasodilators. While older drugs like TENORMIN retain market segments, the shift towards more selective beta-blockers and fixed-dose combinations has marginally eroded atenolol's market share [2].

Generic competition further amplifies price competition, but also constrains profit margins for manufacturers.

3. Demographic and Epidemiological Trends

Cardiovascular disease (CVD) remains a leading cause of mortality worldwide, with hypertension affecting over 1.3 billion people [3]. Aging populations in developed nations sustain the demand for antihypertensives. However, clinical practice shifts favoring newer agents and personalized medicine approaches limit the exclusive reliance on atenolol.

Emerging markets continue to present growth opportunities owing to increasing CVD burden, where atenolol remains a cost-effective therapeutic option due to its generic availability.

4. Patent Status and Market Entry Barriers

TENORMIN’s patent expired in the late 1990s, leading to widespread generic manufacturing. This significantly reduced barriers to entry, intensifying price competition but also diluting revenue streams for brand owners. Market share now largely depends on formulary preferences and regional prescribing habits.

5. Manufacturing and Supply Chain Factors

Robust manufacturing infrastructure for generics ensures steady supply; however, geopolitical issues, regulatory compliance costs, and supply chain disruptions (exacerbated during the COVID-19 pandemic) can influence availability and pricing.

Financial Trajectory

1. Revenue Trends

Historically, TENORMIN generated substantial revenues for AstraZeneca, with peak sales in the 1980s-1990s. Post-patent expiry, revenue contributions declined markedly. According to industry estimates, atenolol sales have stabilized at a significantly lower level, primarily driven by generic sales in emerging markets.

2. Profitability and Market Share

Generic competition and clinical skepticism have restrained profit margins. The global market share for atenolol-based products has shrunk, but consistent demand in cost-sensitive markets sustains steady cash flows. Manufacturers that effectively leverage supply chain efficiencies and regional formulary inclusion can maintain profitability.

3. Investment and R&D Outlook

Given the mature market status, direct investment in TENORMIN’s further development or formulation innovations is limited. Instead, companies focus on expanding into niche segments like fixed-dose combinations or novel beta-blockers with improved selectivity and side-effect profiles.

4. Regulatory and Pricing Pressures

Increased regulatory scrutiny to demonstrate comparative effectiveness and safety exerts downward pressure on pricing. Reimbursement policies in OECD countries favor newer, branded drugs, further marginalizing older compounds like TENORMIN.

5. Future Growth Projections

Forecasts suggest a modest decline in global sales of TENORMIN over the next five years, partly offset by growth in developing economies. The compound annual growth rate (CAGR) is projected to be negative, around -2% to -3%, contingent on regional prescriptive trends and regulatory environment.

Strategic Considerations for Market Stakeholders

• Market Diversification: Focus on emerging markets where affordability and existing prescribing habits sustain demand.

• Product Differentiation: Explore fixed-dose combinations or novel formulations to extend product lifecycle.

• Regulatory Engagement: Leverage regulatory pathways for new indications or repurposing to sustain revenues.

• Cost Management: Optimize manufacturing and distribution to preserve margins amid price erosion.

Conclusion

TENORMIN’s market dynamics reflect the maturation of the beta-blocker segment, influenced heavily by changing clinical guidelines, emerging competition, and regulatory trends. While its revenue trajectory has plateaued or declined in mature markets, emerging economies and generic channels offer stabilization potential. The strategic focus should pivot towards lifecycle management, regional market expansion, and value-added formulations to sustain financial performance.

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Key Takeaways

• TENORMIN’s market share is declining in developed nations due to clinical preference shifts, favoring newer or more selective beta-blockers.

• Generic competition has significantly lowered prices, capping profitability but maintaining steady sales in cost-sensitive markets.

• Regulatory scrutiny over atenolol’s efficacy compared to alternatives may limit future prescribing.

• Emerging markets present growth opportunities driven by increasing cardiovascular disease burdens and price-sensitive healthcare systems.

• Strategic innovations and regional expansion are essential for prolonging the financial viability of TENORMIN in a competitive landscape.

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FAQs

1. What are the primary indications for TENORMIN (atenolol)?
   Atenolol is predominantly prescribed for hypertension management, angina pectoris, and certain cardiac arrhythmias, owing to its beta-adrenergic blocking properties.

2. Why has TENORMIN’s market share declined in recent years?
   Clinical evidence questions its comparative efficacy against newer agents; regulatory reviews have highlighted metabolic risks; and the advent of more selective beta-blockers and combination therapies have shifted prescribing practices.

3. What regions are most promising for TENORMIN’s future sales?
   Emerging markets in Asia, Africa, and Latin America offer growth potential due to high CVD prevalence and cost-effective generics. Developed nations tend to favor newer drugs, limiting growth prospects there.

4. How does patent expiry impact TENORMIN’s market?
   Patent expiration in the late 1990s led to widespread generic manufacturing, intensifying price competition and reducing revenue margins for branded formulations.

5. What strategies can pharmaceutical companies adopt to sustain TENORMIN’s market presence?
   Focus on regional expansion, develop fixed-dose combination products, seek regulatory approvals for new indications, and improve manufacturing efficiencies to maintain profitability amid competition.

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References

[1] Bangalore, S., et al. (2014). "Beta-blocker therapy and clinical outcomes." Circulation, 129(20), 2200-2208.
[2] World Health Organization. (2019). Global Status Report on Noncommunicable Diseases.
[3] World Health Organization. (2021). Hypertension Fact Sheet.