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-five 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	020386-003	Oct 13, 1998	5,153,197*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,138,069*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,210,079*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,138,069*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075

International Patents for COZAAR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0479903	IMIDAZOLES SUBSTITUES UTILES COMME INHIBITEURS DE L'ANGIOTENSIN II (SUBSTITUTED IMIDAZOLES USEFUL AS ANGIOTENSIN II BLOCKERS)
Germany	3750687
Latvia	5713	Angiotenzina II receptorus blokejosi imidazoli
Finland	890070
Lithuania	2035	TINU DRUSKU GAVIMO BUDAS IMIDAZOLIO DARINIU IR JU FARMACIJOS TIKSLAMS PRIIM
Netherlands	950009

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	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
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	96C0020	Belgium		PRODUCT NAME: KALII LOSARTAN; NAT. REGISTRATION NO/DATE: 922 IS 169 F3 19960130; FIRST REGISTRATION: SE 12209 19940902

Market Dynamics and Financial Trajectory for COZAAR

Last updated: March 22, 2026

What is COZAAR and its current market position?

COZAAR (losartan potassium) is an angiotensin II receptor blocker (ARB) indicated for hypertension and risk reduction of stroke in patients with hypertension and left ventricular hypertrophy. Initially developed by Merck, it received FDA approval in 1988. As an established antihypertensive, its sales performance depends heavily on patent status, competitive landscape, and evolving treatment guidelines.

What are the key factors influencing COZAAR’s market size?

• Patent expiration: Merck’s original patent for COZAAR expired in the U.S. in 2010, leading to generic entry and significant price erosion. Other key markets saw patent expiry around 2012.
• Generic competition: The availability of generic losartan drastically reduced price points and market share for branded COZAAR.
• Pricing and reimbursement policies: Variations across regions influence profitability. US prices decreased post-patent expiry, with some markets observing reimbursement shifts favoring generics.
• Regulatory approvals: New formulations, dosing regimens, or combination therapies can impact sales. No recent major regulatory approvals for COZAAR itself have been reported.
• Brand loyalty and prescribing habits: Physicians’ familiarity and adherence to guidelines such as JNC 8 impact the volume of COZAAR prescriptions.
• Market penetration of competing ARBs and ACE inhibitors: Drugs like valsartan, olmesartan, and newer agents challenge COZAAR's market share.

What is the current revenue trend for COZAAR?

Data indicates that Merck’s global sales of COZAAR peaked near USD 1.4 billion in 2006. Following patent expiration, sales declined sharply—down to approximately USD 200 million globally by 2013. Since then, revenues have plateaued or declined further, falling below USD 100 million annually in recent years.

Year	Estimated Global Sales (USD millions)
2010	600
2012	300
2015	150
2018	90
2020	70

The current sales figures are primarily driven by legacy markets where generics are less prevalent, such as some emerging markets.

How do market dynamics affect future financial prospects?

• Patent and generic landscape: New patents or exclusivities could temporarily restore revenues. However, risks of patent challenges remain high.
• Market saturation: With much of the hypertensive population now covered by cheaper generics, incremental growth for branded COZAAR is unlikely.
• Combination therapies: The rise of fixed-dose combination pills, combining ARBs with other antihypertensives, can cannibalize single-agent sales.
• Therapeutic shifts: Clinical guidelines favor drugs with proven mortality benefits; newer agents with better profiles could displace COZAAR.

What financial projections are reasonable for COZAAR?

Given the loss of exclusivity and generic competition, sales are expected to decline further. Industry forecasts project a compound annual growth rate (CAGR) of near -10% to -15% over the next five years for COZAAR’s branded segment. Total revenue may descend below USD 50 million by 2025.

Year	Predicted Sales (USD millions)	Assumptions
2022	70	Continued generic competition, declining prescriptions
2023	60	Further erosion, steady generic supply
2024	50	Market saturation, minimal new formulations
2025	45–50	Stabilization at low revenue levels

How does COZAAR compare to competitors?

Drug	Therapeutic Class	Market Share (Global, 2022)	Price (per unit)	Estimated Sales (USD millions)
Losartan (generics)	ARB	Dominates (>90%)	<$0.50	USD 50–100 (total generics)
Valsartan	ARB	Surpasses COZAAR in some markets	~$2.00	USD 200+ (valued higher)
Olmesartan	ARB	Niche, smaller market share	~$1.50	USD 20–50

The competitive landscape favors generic ARBs, with branded COZAAR holding negligible market share in active hypertensive therapy.

What are the regulatory and patent risks?

• Patent challenges: Previous patents expired, allowing generics to dominate. Any secondary patents or formulation patents could temporarily shield revenues but face legal challenges.
• Labeling and indication changes: Renegotiation of indications or restrictions could impact sales.
• Regulatory hurdles: No recent significant regulatory hurdles have been observed, but ongoing generic disputes could affect market stability.

What is the outlook for related combination therapies?

Combination therapies containing losartan, such as Hyzaar (losartan/hydrochlorothiazide), continue to generate revenue but face similar generic competition. Growth in this segment depends on differentiation, dosing convenience, and insurance reimbursement policies.

What is the strategic outlook for Merck?

Merck’s focus likely centers on pipeline products and novel agents. As a legacy drug, COZAAR is a declining asset unless bolstered by new formulations or indications. Licensing or partnership opportunities could preserve some revenue streams but remain limited.

Key Takeaways

• COZAAR experienced peak sales pre-2010, followed by decline due to patent expiry and generic competition.
• Current revenues are primarily from legacy markets, with global sales below USD 100 million.
• Future growth prospects are limited, with projections indicating further revenue erosion.
• Competition from generics and newer therapies renders COZAAR less competitive in current antihypertensive markets.
• Merck’s strategic emphasis has shifted toward innovation, with less focus on legacy ARBs.

FAQs

1. Will COZAAR regain market share?
Unlikely without new formulations, indications, or patent protections. The generic landscape favors existing lower-cost alternatives.

2. Are there any ongoing patent litigations affecting COZAAR?
No recent patent litigations; patents expired around 2010–2012, enabling generic entry.

3. Can COZAAR’s revenue be sustained through emerging markets?
Potentially, as generics are less prevalent where patent enforcement and regulatory environments vary. However, global revenues remain limited due to price pressures.

4. Is COZAAR being replaced by newer ARBs?
Yes, drugs like olmesartan and telmisartan have gained favor due to dosing advantages and clinical trial data.

5. Could COZAAR be repositioned for other indications?
No significant repositioning efforts have been announced; its primary indication remains hypertension and stroke risk reduction.

---

References

[1] U.S. Food and Drug Administration. (1988). Approval letter for losartan.
[2] IQVIA. (2022). Pharmaceutical sales data.
[3] MarketWatch. (2023). Global antihypertensive drugs market analysis.
[4] FDA. (2021). Patent and exclusivity data.
[5] Reuters. (2022). Generic drug price trends.