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, 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-six 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-nine suppliers are listed for this compound.

Summary for losartan potassium

International Patents:	1
US Patents:	2
Tradenames:	3
Applicants:	26
NDAs:	26
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	86
Patent Applications:	4,107
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
Gadjah Mada University	Phase 1/Phase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Steadman Philippon Research Institute	Phase 2

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
Unichem	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	203030-001	Oct 14, 2015	AB	RX	No	No
Apotex	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	218551-001	Jun 4, 2024		DISCN	No	No
Mylan	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	091590-001	Oct 6, 2010		DISCN	No	No
Scienture	ARBLI	losartan potassium	SUSPENSION;ORAL	218772-001	Mar 13, 2025		RX	Yes	Yes	11,890,273		Y
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	AB	RX	Yes	Yes
Apotex	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	218551-002	Jun 4, 2024		DISCN	No	No
Lupin Ltd	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	078232-003	Oct 6, 2010	AB	RX	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	5,138,069*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
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-002	Apr 14, 1995	5,608,075*PED
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	020386-001	Apr 14, 1995	5,608,075

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	98C0030	Belgium		PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215
0733366	SZ 25/1998	Austria		PRODUCT NAME: LOSARTAN-KALIUM UND HYDROCHLOROTHIAZID
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
0253310	SZ 16/1996	Austria		PRODUCT NAME: LOSARTAN-KALIUM

Market Dynamics and Financial Trajectory of Losartan Potassium

Last updated: July 4, 2025

Introduction

In the competitive world of pharmaceuticals, losartan potassium stands out as a cornerstone treatment for hypertension, offering insights into broader market trends and financial shifts. As a generic angiotensin II receptor blocker (ARB), this drug has navigated patent expirations, rising generic competition, and evolving regulatory landscapes. For business professionals tracking healthcare investments, understanding its dynamics provides a roadmap to profitability and risk in a maturing market.

Overview of Losartan Potassium

Losartan potassium, first approved by the FDA in 1995, targets high blood pressure by blocking angiotensin II receptors, reducing vascular resistance and fluid retention. Its efficacy in managing hypertension, along with off-label uses for diabetic nephropathy, has sustained demand for decades. Unlike newer ARBs, losartan benefits from a well-established safety profile, making it a go-to option in both developed and emerging markets.

The drug's generic status, following Merck's original patent expiration in 2010, has democratized access, lowering costs and expanding availability. Today, manufacturers produce it in various formulations, including tablets and combinations with hydrochlorothiazide. This evolution underscores how legacy drugs like losartan adapt to maintain relevance amid innovation.

Current Market Dynamics

The global market for losartan potassium reflects steady growth, driven by the rising prevalence of cardiovascular diseases. In 2023, the hypertension treatment market reached approximately $25 billion worldwide, with losartan capturing a significant share due to its affordability and proven results.

Market Size and Growth Drivers

Losartan potassium's market size has expanded at a compound annual growth rate (CAGR) of about 4% since 2018, fueled by an aging population and increasing hypertension rates. The World Health Organization reports that over 1.28 billion adults aged 30-79 worldwide have hypertension, a figure projected to rise with urbanization and lifestyle changes. In regions like Asia-Pacific, demand surges as healthcare infrastructure improves, boosting sales volumes.

Key growth drivers include cost-effectiveness, with generic losartan priced as low as $0.10 per tablet in some markets, compared to branded alternatives. Regulatory approvals for bioequivalent generics have intensified supply, particularly in high-volume areas like India and China. However, supply chain disruptions, such as those during the COVID-19 pandemic, have introduced volatility, with shortages in Europe highlighting vulnerabilities.

Key Players and Competition

Competition in the losartan market is fierce, dominated by generic manufacturers like Teva Pharmaceuticals, Mylan, and Sandoz. These players leverage economies of scale to undercut prices, eroding margins for newcomers. In the U.S., over 50 companies supply the drug, creating a fragmented landscape that favors bulk buyers like pharmacy chains.

Branded competitors, such as Novartis's Diovan (valsartan), pose indirect threats by offering similar benefits with potential premium pricing. Yet, losartan's edge lies in its long history and lower incidence of recalls—unlike valsartan, which faced FDA warnings in 2018 due to impurities. This has solidified losartan's position in cautious markets like North America and Europe, where trust drives purchasing decisions.

Emerging players in generic production, such as Chinese firms like Zhejiang Huahai Pharmaceutical, add pressure through aggressive exports. Trade policies, including U.S. tariffs on Chinese imports, could reshape dynamics, potentially favoring domestic producers and altering global supply chains.

Financial Trajectory

Losartan potassium's financial path illustrates the lifecycle of a pharmaceutical product: rapid growth during patent exclusivity, followed by stabilization as generics proliferate. From peak revenues in the early 2000s under Merck's Cozaar brand, the drug has transitioned to a commodity-like status.

Revenue Trends and Sales Performance

Global sales of losartan reached around $2.5 billion in 2022, according to industry reports, with the majority from generic formulations. In the U.S., revenues dipped post-patent expiration but stabilized through volume gains, hitting $500 million in 2023. Emerging markets contribute significantly, accounting for 60% of total sales, as affordability drives adoption in countries like Brazil and India.

Quarterly data from IQVIA shows a 2-3% year-over-year increase in unit sales, reflecting steady demand. However, price erosion remains a challenge; average wholesale prices have fallen 15% since 2019 due to generic competition. Companies like Teva report losartan as a high-volume, low-margin product, contributing to overall portfolio stability rather than blockbuster profits.

Profitability and Financial Challenges

Profitability for losartan hinges on operational efficiency. Gross margins for generic producers range from 30-50%, depending on manufacturing costs and market access. For instance, Teva's 2023 earnings highlighted losartan as a steady revenue generator, though net profits lag behind innovative drugs due to pricing pressures.

Financial challenges include regulatory fines and recalls, which can erode gains. In 2019, the FDA issued warnings for potential carcinogens in some losartan batches, temporarily halving sales for affected manufacturers. Inflation in raw materials, such as active pharmaceutical ingredients, further strains finances, with costs rising 10-20% in 2022 alone.

Despite these hurdles, losartan's financial trajectory shows resilience. Investors view it as a defensive asset in pharmaceutical portfolios, offering predictable cash flows amid economic uncertainty.

Regulatory Environment and Patents

Regulatory scrutiny defines losartan's landscape, with agencies like the FDA and EMA enforcing strict quality standards. Post-2010 patent expiration, the drug entered a generics-friendly era, but ongoing approvals for new formulations keep it relevant. For example, the FDA approved extended-release versions in 2021, extending market life.

Patents play a minimal role now, but secondary protections, such as those for combination therapies, provide temporary shields. In Europe, the EMA's focus on impurity testing has led to market withdrawals, impacting financials for exporters. Businesses must monitor these regulations to mitigate risks, as non-compliance can result in costly delays or bans.

Future Outlook

Looking ahead, losartan potassium's market will likely grow at a modest 3-5% CAGR through 2030, driven by demographic shifts and generic expansions. Opportunities in personalized medicine could emerge, with research into biomarkers potentially differentiating losartan in niche segments. However, biosimilar threats from next-generation ARBs may cap growth.

Financial projections indicate stable revenues, with potential upticks in underserved regions. Companies investing in supply chain resilience and sustainability will gain an edge, as global health initiatives prioritize affordable hypertension treatments. For stakeholders, this trajectory signals a mature investment with limited upside but reliable returns.

Key Takeaways

• Losartan potassium maintains strong demand in the hypertension market, supported by its affordability and efficacy, despite generic competition.
• Revenue trends show stabilization at around $2.5 billion annually, with growth opportunities in emerging markets offsetting price declines.
• Regulatory challenges, including impurity concerns, pose risks to profitability, emphasizing the need for robust compliance.
• The drug's financial trajectory highlights the importance of operational efficiency for generic manufacturers in a commoditized space.
• Future prospects depend on innovation in formulations and market expansion, offering steady but not explosive growth for investors.

FAQs

1. What factors are driving the current demand for losartan potassium?
Demand stems from its cost-effectiveness and role in treating hypertension, particularly in aging populations and developing regions where access to branded drugs is limited.

2. How has the patent expiration affected losartan's financial performance?
The 2010 patent expiry led to revenue drops for original manufacturers due to generic entry, but overall market volumes have increased, stabilizing finances through higher sales quantities.

3. What competition does losartan face in the ARB market?
It competes with other ARBs like valsartan and irbesartan, where generics dominate, but losartan's established safety record gives it an advantage in risk-averse markets.

4. Are there any recent regulatory changes impacting losartan?
Recent FDA and EMA guidelines on impurity testing have caused temporary supply issues, potentially affecting sales and requiring manufacturers to enhance quality controls.

5. What investment opportunities exist in the losartan market?
Opportunities lie in generic production efficiencies and expansion into emerging markets, though investors should watch for price erosion and regulatory risks.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Outlook." IQVIA, 2023.
2. World Health Organization. "Hypertension Fact Sheet." WHO, 2023.
3. U.S. Food and Drug Administration. "FDA Approvals and Safety Communications for Losartan Potassium." FDA, accessed 2024.