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-one 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 ALEMBIC PHARMS LTD 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:	187
Clinical Trials:	78
Patent Applications:	4,391
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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Mayo Clinic	Phase 3
Colin D. Weekes, M.D.	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
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,608,075*PED

International Patents for COZAAR

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

Country	Patent Number	Title	Estimated Expiration
Canada	1334092	IMIDAZOLES BLOQUANT LES RECEPTEURS DE L'ANGIOTENSINE II (ANGIOTENSIN II RECEPTOR BLOCKING IMIDAZOLES)
Hungary	9902075
Australia	599396
Finland	99012
Finland	96025
Hungary	218461	Szubsztituált imidazolszármazékok, és hatóanyagként e vegyületeket tartalmazó gyógyszerkészítmények (SUBSTITUTED IMIDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AS ACTIVE INGREDIENTS)
Hong Kong	55495	Angiotensin II receptor blocking imidazoles.

Supplementary Protection Certificates for COZAAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0733366	98C0030	Belgium		PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215
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
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
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

COZAAR Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for COZAAR (Losartan)

Introduction

COZAAR, commonly known by its generic name losartan, is an angiotensin II receptor blocker (ARB) primarily used to treat hypertension and other cardiovascular conditions. The market for losartan is experiencing significant growth, driven by several key factors. Here, we will delve into the market dynamics and financial trajectory of losartan.

Market Size and Growth

The global losartan market has been steadily increasing in recent years. As of 2023, the market was valued at approximately $1.5 billion and is projected to reach $2.3 billion by 2034, growing at a compound annual growth rate (CAGR) of 4% between 2024 and 2034[1].

Key Drivers of Growth

Several factors are driving the growth of the losartan market:

Increasing Prevalence of Hypertension

The rising incidence of hypertension worldwide, attributed to aging populations, sedentary lifestyles, and dietary factors, is a significant driver. Hypertension is a prevalent health concern, particularly in regions with large elderly populations such as North America and Europe[1][3].

Geriatric Population and Prefrailty

The increasing geriatric population, especially the prefrail segment, is another crucial factor. Prefrail individuals are at higher risk of adverse health outcomes, and losartan's role in managing cardiovascular health makes it a vital treatment option for this demographic[1].

Healthcare Infrastructure and Awareness

Robust healthcare infrastructure and access to medical resources in regions like North America and Asia Pacific support the consistent demand for losartan. Awareness campaigns in populous nations such as India and China further bolster the consumer base, emphasizing losartan's role in preventing cardiovascular complications[1][3].

Regional Market Analysis

North America

North America is forecasted to hold the largest share of the losartan market. The region's significant growth is driven by the high prevalence of hypertension and a strong healthcare system. In 2024, North America's losartan market size was estimated at $650.2 million, with a CAGR of 2.7% from 2024 to 2031[3].

Asia Pacific

The Asia Pacific region is expected to experience substantial growth, driven by the large population and increasing prevalence of cardiovascular disorders and high blood pressure. The region's losartan market size was estimated at $373.87 million in 2024, with a CAGR of 6.5% from 2024 to 2031[3].

Europe

Europe also holds a significant share of the global losartan market, with an estimated market size of $487.65 million in 2024. The region is expected to grow at a CAGR of 3.0% from 2024 to 2031[3].

Other Regions

South America, the Middle East, and Africa also contribute to the global losartan market, although at a slower growth rate compared to North America and Asia Pacific. These regions are expected to see growth driven by increasing awareness and improving healthcare infrastructure[3].

Market Segmentation

Dosage Form

Losartan is available in various dosage forms, including tablets, powders, and suspensions. The tablet form is the most common due to its ease of administration and stability[1][5].

Application

Losartan is primarily used to treat hypertension but also has applications in managing stroke, diabetic nephropathy, and other cardiovascular conditions[1][5].

Distribution Channel

The distribution channels for losartan include contract manufacturing, in-house manufacturing, and others. The market is also seeing a rise in online distribution channels, which are becoming increasingly popular due to convenience and accessibility[1][5].

Competitive Landscape

The competitive landscape of the losartan market includes pharmaceutical giants and biotechnology firms. These companies are investing in clinical trials and strategic partnerships to advance treatment options and ensure regulatory compliance. This competition drives innovation and meets the growing global demand for effective cardiovascular therapies[1].

Financial Performance

The financial performance of companies involved in the losartan market is influenced by several factors, including sales volume, pricing, and operational costs. For instance, strong demand and recent product launches have driven the net sales of generics, including losartan, in companies like Sandoz, with net sales of generics reaching $7.4 billion in 2023[2].

Future Outlook

Looking ahead, the losartan market is poised for continued growth driven by ongoing research, demographic trends, and the imperative to improve healthcare outcomes globally. As medical science progresses and the understanding of losartan's therapeutic potential expands, it is anticipated to play an increasingly pivotal role in cardiovascular health management and potentially broader therapeutic applications[1].

Key Takeaways

• Market Size: The global losartan market is projected to reach $2.3 billion by 2034.
• Growth Rate: The market is expected to grow at a CAGR of 4% between 2024 and 2034.
• Regional Dominance: North America holds the largest share, followed by Europe and Asia Pacific.
• Key Drivers: Increasing prevalence of hypertension, growing geriatric population, and robust healthcare infrastructure.
• Market Segmentation: Various dosage forms, applications, and distribution channels.

FAQs

Q: What is the primary use of losartan?

A: Losartan is primarily used to treat hypertension and other cardiovascular conditions.

Q: Which region dominates the losartan market?

A: North America currently dominates the losartan market, followed by Europe and Asia Pacific.

Q: What is driving the growth of the losartan market?

A: The growth is driven by the increasing prevalence of hypertension, the growing geriatric population, and robust healthcare infrastructure.

Q: What are the different dosage forms of losartan?

A: Losartan is available in tablet, powder, and suspension forms.

Q: What is the projected CAGR for the losartan market from 2024 to 2034?

A: The market is expected to grow at a CAGR of 4% between 2024 and 2034.

Sources

1. Transparency Market Research: "Losartan Market is projected to expand to USD 2.3 billion at a CAGR of 4% between 2024 and 2034"[1].
2. Sandoz Financial Report: "Financial Report 2023"[2].
3. Cognitive Market Research: "Losartan Market Report"[3].
4. Merck Financial Results: "Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results"[4].
5. ResearchAndMarkets.com: "Global Losartan Market (2020 to 2026)"[5].