COZAAR Drug Patent Profile

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

Cozaar is a drug marketed by Organon and is included in one NDA.

The generic ingredient in COZAAR is losartan potassium. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the losartan potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cozaar

A generic version of COZAAR was approved as losartan potassium by AIPING PHARM INC on October 6^th, 2010.

Summary for COZAAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	78
Patent Applications:	3,486
Drug Prices:	Drug price information for COZAAR
What excipients (inactive ingredients) are in COZAAR?	COZAAR excipients list
DailyMed Link:	COZAAR at DailyMed

See drug prices for COZAAR

See drug sales revenues for COZAAR

Recent Clinical Trials for COZAAR

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

Sponsor	Phase
Mayo Clinic	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Actuate Therapeutics	Phase 2

See all COZAAR clinical trials

Pharmacology for COZAAR

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

US Patents and Regulatory Information for COZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	AB	RX	Yes	No
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	AB	RX	Yes	No
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	AB	RX	Yes	Yes

Expired US Patents for COZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,210,079*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,153,197*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,608,075*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,138,069*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,210,079*PED

International Patents for COZAAR

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

Country	Patent Number	Title	Estimated Expiration
Hungary	9902075
Latvia	5713	Angiotenzina II receptorus blokejosi imidazoli
Denmark	0533840
Japan	H09507075
Japan	H03501020
European Patent Office	0733366	Compositions pharmaceutiques comprenant des imidazoles comme antagonistes d'angiotensine II et des diurétiques (Pharmaceutical compositions comprising angiotensin II receptor blocking imidazoles and diuretics)

Supplementary Protection Certificates for COZAAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
0253310	SZ 16/1996	Austria		PRODUCT NAME: LOSARTAN-KALIUM
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0733366	SZ 25/1998	Austria		PRODUCT NAME: LOSARTAN-KALIUM UND HYDROCHLOROTHIAZID
0253310	96C0020	Belgium		PRODUCT NAME: KALII LOSARTAN; NAT. REGISTRATION NO/DATE: 922 IS 169 F3 19960130; FIRST REGISTRATION: SE 12209 19940902
0253310	C950009	Netherlands		PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902

Market Dynamics and Financial Trajectory for Cozaar

Last updated: July 28, 2025

Introduction

Cozaar (generic name: losartan potassium) is an angiotensin II receptor blocker (ARB) primarily prescribed for hypertension management and diabetic nephropathy. Since its launch, Cozaar has maintained a significant position within the antihypertensive drug market. Analyzing its market dynamics and financial trajectory offers insights into its growth prospects, competitive positioning, and potential challenges facing stakeholders.

Market Overview

The global antihypertensive drugs market was valued at approximately USD 17 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030[^1]. Losartan, introduced in the late 1990s by Merck (now part of MSD), was among the first ARBs to gain FDA approval. Its success was driven by a shift towards ARBs as preferred antihypertensive agents over ACE inhibitors, due to fewer side effects like cough[^2].

Key Market Drivers

1. Growing Global Hypertension Prevalence

   Hypertension affects over 1.3 billion adults globally and is a major risk factor for cardiovascular disease[^3]. As the global burden of hypertension rises, demand for effective antihypertensive therapies like Cozaar correspondingly increases.

2. Expansion in Developing Markets

   Increased healthcare infrastructure and rising awareness bolster drug access in emerging economies such as China, India, and Brazil. These markets present significant revenue opportunities, particularly for established drugs like losartan[^4].

3. Preference for ARBs

   Healthcare providers increasingly favor ARBs like Cozaar over older drugs such as beta-blockers or diuretics, given their tolerability profile. Among ARBs, losartan remains a cost-effective and well-established option[^2].

4. Additional Therapeutic Uses

   Cozaar’s indication for diabetic nephropathy expands its use beyond hypertension, tapping into the growing diabetic patient pool worldwide.

Market Challenges

1. Patent Expiry and Generic Competition

   Cozaar’s primary patent protections expired around 2010 in the U.S., leading to a surge in generic versions. As a result, brand-name sales diminished sharply, reducing revenue streams[^5].

2. Pricing Pressure and Healthcare Cost Containment

   Governments and insurers increasingly leverage formulary control and price negotiations to contain costs, especially for generic drugs. This trend diminishes profit margins for original branded drugs.

3. Emerging Alternatives and Fixed-Dose Combinations

   The advent of new ARBs, ACE inhibitors, and fixed-dose combination therapies offers more options, challenging losartan’s market share[^6].

4. Regulatory and Market Access Challenges

   Stringent regulations, approval processes, and payer restrictions in key markets continue to influence sales trajectories.

Financial Trajectory Analysis

Historical Performance

Since patent expiration, sales of Cozaar have sharply declined. Merck reported that in 2010, Cozaar generated approximately USD 2 billion globally, with a significant decline in subsequent years due to generic erosion[^7]. The decline plateaued over the last decade, reflecting the reduced contribution of the original branded product.

Post-Patent Strategy and Diversification

To mitigate revenue loss, Merck shifted focus toward development of combination therapies incorporating losartan and other antihypertensive agents. These combinations aim to sustain sales by offering improved efficacy and adherence[^8].

Market Share in the Current Landscape

Despite generic competition, losartan retains a presence in certain segments, especially where healthcare systems favor older, well-established drugs. However, its market share has dwindled significantly compared to newer ARBs like valsartan and olmesartan.

Emerging Opportunities

• New Formulations and Fixed-Dose Combinations: Mergers and product innovations, such as losartan-based combination drugs, are avenues for growth[^9].

• Biomarker and Pharmacogenomic Precision Medicine: Tailoring therapies may enhance efficacy and adherence, especially among diabetic populations, potentially rejuvenating demand for drugs like Cozaar[^10].

Future Outlook

The forecast indicates that Cozaar, as a branded product, will have a limited role in future revenue streams. The focus shifts to generic sales, niche indications, and combination therapies. Market saturation, patent expiries, and evolving treatment guidelines will further compress profit margins.

Growth in Emerging Markets

Emerging markets provide window opportunities for losartan-containing generics, driven by cost sensitivity and expanding hypertensive populations[^4]. The volume-based growth in these regions can offset declines in developed markets.

Incorporating Digital and Biosimilar Trends

While biosimilars are less relevant for small-molecule drugs like losartan, digital health initiatives may influence adherence and prescription patterns, indirectly impacting utilization rates.

Conclusion

The market dynamics for Cozaar are shaped by patent expirations, fierce generic competition, and evolving therapeutic landscapes. Its financial trajectory highlights a transition from branded dominance to a predominantly generic-driven revenue model. Strategic focus on combination therapies and emerging markets may temper decline but are unlikely to reverse the overall trend of reduced profitability linked to the original molecule.

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Key Takeaways

• Patent expiration of Cozaar in 2010 led to significant revenue decline due to generic competition.
• Global hypertension trends sustain demand for ARBs, including losartan, especially in emerging markets.
• Market shifts favor newer ARBs and fixed-dose combinations, challenging Cozaar’s market position.
• Diversification efforts, such as combination therapies, are vital for maintaining relevance and revenue.
• Emerging markets offer growth opportunities, driven by affordability and expanding hypertensive patient populations.

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FAQs

1. How did patent expiry impact Cozaar’s sales?
Patent expiry in 2010 triggered the entry of generics, leading to a substantial decline in Cozaar's sales—merging the brand’s market share into the broader generic segment.

2. What strategies are pharmaceutical companies using to sustain revenue from Cozaar?
Companies are developing combination therapies, expanding indications, and focusing on emerging markets to offset losses from patent expiration.

3. How does Cozaar compare with newer ARBs in terms of clinical efficacy?
Clinical efficacy among ARBs, including losartan, is generally comparable; choice often depends on tolerability, cost, and patient-specific factors.

4. What are the prospects for Cozaar in the next decade?
Branded Cozaar's prospects are limited; growth hinges on niche markets, combination drugs, and generics, primarily in developing economies.

5. Are there any ongoing innovations related to losartan?
Research focuses on new formulations, fixed-dose combinations, and exploring pharmacogenomic approaches to optimize therapy, although no groundbreaking innovations have yet emerged.

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References

[1] Market Research Future. "Global Antihypertensive Drugs Market," 2022.
[2] U.S. Food & Drug Administration. “Losartan Potassium—Approval and Market Data.”
[3] World Health Organization. “Global Status Report on Noncommunicable Diseases,” 2021.
[4] IQVIA. “Emerging Markets in Hypertension Treatment,” 2022.
[5] Merck Annual Report, 2010.
[6] Statistical analyses of ARB market share, 2022.
[7] Merck financial disclosures, 2010–2022.
[8] Industry analysis reports on combination therapies, 2021.
[9] PhRMA. “Market Trends in Cardiovascular Drugs,” 2022.
[10] NIH PubMed. “Pharmacogenomics of ARBs,” 2021.