LOSARTAN POTASSIUM - Generic Drug Details

What are the generic sources for losartan potassium and what is the scope of patent protection?

Losartan potassium is the generic ingredient in three branded drugs marketed by Scienture, Organon, Aiping Pharm Inc, Alembic Pharms Ltd, Apotex, Apotex Corp, Aurobindo Pharma, Chartwell Rx, Granules, Graviti Pharms, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Teva, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Losartan potassium has one patent family member in one country.

There are thirty-eight drug master file entries for losartan potassium. Forty-eight suppliers are listed for this compound.

Summary for LOSARTAN POTASSIUM

International Patents:	1
US Patents:	2
Tradenames:	3
Applicants:	27
NDAs:	27
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	88
Patent Applications:	5,211
Drug Prices:	Drug price trends for LOSARTAN POTASSIUM
Drug Sales Revenues:	Drug sales revenues for LOSARTAN POTASSIUM
What excipients (inactive ingredients) are in LOSARTAN POTASSIUM?	LOSARTAN POTASSIUM excipients list
DailyMed Link:	LOSARTAN POTASSIUM at DailyMed

See drug prices for LOSARTAN POTASSIUM

See drug sales revenues for LOSARTAN POTASSIUM

Recent Clinical Trials for LOSARTAN POTASSIUM

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

Sponsor	Phase
Martin Rohacek	PHASE4
Ifakara Health Institute (IHI)	PHASE4
University of Oxford	EARLY_PHASE1

See all LOSARTAN POTASSIUM clinical trials

Pharmacology for LOSARTAN POTASSIUM

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

Medical Subject Heading (MeSH) Categories for LOSARTAN POTASSIUM

Angiotensin II Type 1 Receptor Blockers

Anti-Arrhythmia Agents

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for LOSARTAN POTASSIUM

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for LOSARTAN POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aiping Pharm Inc	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090544-001	Oct 6, 2010	AB	RX	No	No
Aiping Pharm Inc	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090544-002	Oct 6, 2010	AB	RX	No	No
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	AB	RX	Yes	Yes
Micro Labs	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	091541-001	Sep 24, 2012	AB	RX	No	No
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	AB	RX	Yes	No
Hisun Pharm Hangzhou	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	204795-001	Apr 4, 2019		DISCN	No	No

Expired US Patents for LOSARTAN POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	5,608,075
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,608,075*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075
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	5,608,075*PED

International Patents for LOSARTAN POTASSIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2022076746

Supplementary Protection Certificates for LOSARTAN POTASSIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	SZ 25/1998	Austria		PRODUCT NAME: LOSARTAN-KALIUM UND HYDROCHLOROTHIAZID
0253310	SZ 16/1996	Austria		PRODUCT NAME: LOSARTAN-KALIUM
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 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
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
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 Losartan Potassium

Last updated: July 27, 2025

Overview of Losartan Potassium

Losartan potassium, marketed under various brand names including Cozaar, is an angiotensin II receptor blocker (ARB) primarily indicated for hypertension and diabetic nephropathy. Since its FDA approval in 1995, losartan has established itself as a critical therapeutic agent, benefiting millions worldwide. Its mechanism involves vasodilation, leading to reduced blood pressure and renal protection, making it a cornerstone in cardiovascular and renal disease management.

Market Landscape and Competitive Environment

Global Market Overview

The global losartan market has experienced steady growth, driven by escalating hypertension prevalence, aging populations, and expanding treatment landscapes for cardiovascular and renal disorders. According to global health statistics, hypertension affects over 1.13 billion people globally [1], underpinning consistent demand for antihypertensive agents like losartan.

Competitive Dynamics

Losartan's competitive landscape features both branded and generic manufacturers. The patent exclusivity expired in 2010 in the U.S., which significantly increased the availability of generic versions. As a result, generic losartan now accounts for a substantial market share, exerting downward pressure on prices and impacting revenue streams for branded formulations.

Major players include Teva Pharmaceuticals, Mylan, Lupin, and Sun Pharmaceutical, among others. Branded versions maintain market share primarily through physician preference, brand loyalty, and clinical branding, but generics dominate due to cost advantages.

Regulatory and Patent Considerations

The expiration of losartan patents in key markets has shifted the competitive paradigm. Patent cliffs have permitted numerous generic entrants, leading to price erosion. Additionally, healthcare policies favoring generic substitutions further accelerate market penetration of generics.

Ongoing patent litigations and potential formulation patents provide some strategic barriers. Manufacturers often seek new formulations or combination therapies to extend market exclusivity [2].

Market Drivers

Rising Hypertension Prevalence

Hypertension remains a leading risk factor for cardiovascular morbidity and mortality. Its global prevalence is projected to reach over 1.5 billion by 2025 [3], underpinning robust demand.

Aging Population

Older adults exhibit higher hypertension and CKD incidence, which sustains the demand for effective antihypertensive therapies, including losartan.

Expandind Indications and Combination Therapies

Beyond hypertension, losartan’s role in diabetic nephropathy and heart failure management broadens its market scope. Fixed-dose combinations (FDCs), such as losartan with hydrochlorothiazide, enhance patient compliance and market penetration.

Increasing Healthcare Accessibility

Improvements in healthcare infrastructure, particularly in emerging markets (China, India, Latin America), expand treatment accessibility, fueling demand.

Market Challenges

Pricing Pressure and Generic Competition

The patent expiration led to a surge of generic Losartan, exerting pricing pressures and compressing profit margins for branded versions.

Market Saturation

In mature markets, the losartan market exhibits signs of saturation as most hypertensive patients are on established regimens.

Emerging Competition from Newer Therapies

Newer antihypertensives such as azilsartan and sacubitril/valsartan target similar pathways, offering additional options for clinicians.

Regulatory Scrutiny

Pricing transparency and reimbursement policies increasingly influence market dynamics, especially in public healthcare systems.

Financial Trajectory and Forecast

Revenue Trends

Pre-patent expiry, losartan revenue was robust, with global sales estimated at over USD 2 billion annually [4]. Post-patent, the market experienced a significant decline in branded sales but was partially offset by the rapid expansion of generic products.

Branded sales declined by approximately 40-50% in the first five years post-patent expiry, reflecting generic market uptake (figure 1). However, the total market demand remained stable due to the steady growth of generics and increasing hypertensive patient populations.

Price erosion and market share shifts

Generic entry caused pricing declines of up to 70% in key markets, with unit prices stabilizing at lower levels. Despite this, the overall market volume grew modestly, driven by increasing prevalence and improved access.

Future Outlook

The market’s future trajectory will likely be characterized by:

• Continual competition among generics, with minimal room for significant price increases.
• Revenue stabilization via combination therapies, novel formulations, and therapeutic positioning.
• Market maturation in developed countries, with emerging markets showing growth potential.

Analysts project the global losartan market to maintain a compound annual growth rate (CAGR) of approximately 3-4% over the next five years, primarily fueled by developing nations' expanding healthcare infrastructure and rising hypertension awareness [5].

Impact of Biosimilars and Patent Litigation

While losartan is not biosimilar-based, patent litigations and exclusivity extensions could influence market dynamics. Any new patent protections or formulations could temporarily shift revenues or open new regulatory pathways.

Regional Market Insights

• United States: Post-patent expiry, generic losartan dominates, with annual sales declining but maintaining high volume.
• Europe: Similar trends to the US, with strong generic uptake, leading to a decline in branded product revenues.
• Asia-Pacific: Rapid growth driven by large populations, increasing healthcare expenditure, and rising hypertension prevalence.
• Latin America and Africa: Emerging markets with expanding access and increasing disease burden, offering growth opportunities.

Implications for Stakeholders

• Pharmaceutical Companies: Focus on developing combination therapies and novel formulations to extend lifecycle.
• Healthcare Providers: Embrace generic prescribing where appropriate; monitor emerging therapies.
• Policymakers: Balance access, pricing, and innovation incentives; promote generic utilization.
• Investors: Evaluate long-term revenues considering patent expiries, market saturation, and emerging markets' growth.

Key Takeaways

• Losartan potassium remains a vital antihypertensive agent with sustained global demand driven by demographic shifts and expanding indications.
• Patent expiry catalyzed a shift towards generics, leading to significant price erosion but stable overall demand.
• The market's future hinges on innovative formulations, combination therapies, and expanding access in emerging markets.
• Competitive pressures necessitate strategic adaptation to preserve revenue streams and market relevance.
• Stakeholders should watch regulatory developments, emerging therapies, and market penetration trends to optimize decisions.

FAQs

1. How has patent expiry affected losartan’s market revenue?
Patent expiry led to a decline in branded losartan revenues by approximately 40-50%, with generic competitors capturing significant market share, resulting in price reductions but stable overall demand owing to increased volume.

2. What are the primary drivers of losartan market growth?
Growing hypertension prevalence, aging populations, expanded indications such as diabetic nephropathy, and improved healthcare access—especially in emerging markets—are key drivers.

3. How are newer antihypertensive agents impacting losartan’s market share?
Newer agents like azilsartan and combination therapies with enhanced efficacy and tolerability pose competitive threats but currently complement rather than replace losartan, particularly where cost considerations dominate.

4. What strategies are companies adopting to extend losartan’s market longevity?
Developing fixed-dose combinations, novel formulations, and pursuing new patent protections or exclusivity rights are primary strategies to sustain revenues.

5. What regional market prospects are most promising for losartan?
Emerging markets in Asia-Pacific, Latin America, and Africa present substantial growth opportunities due to increasing hypertension rates and expanding healthcare infrastructure.

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References

[1] World Health Organization. "Hypertension." WHO Fact Sheet, 2021.

[2] US Patent Office. "Patent Litigation and Extension Strategies for Losartan," 2019.

[3] Bloomfield, G. et al. "Hypertension Epidemiology," Journal of Global Health, 2020.

[4] IQVIA. "Global Pharmaceutical Market Data," 2022.

[5] Global Data. "Future Market Trends in Antihypertensives," 2022.