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 two branded drugs marketed by 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-five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for LOSARTAN POTASSIUM

US Patents:	0
Tradenames:	2
Applicants:	25
NDAs:	25
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	86
Patent Applications:	3,993
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
Apotex Corp	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090790-003	Oct 6, 2010		DISCN	No	No
Watson Labs	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	091129-002	Oct 6, 2010	AB	RX	No	No
Torrent Pharms	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090467-002	Oct 6, 2010		DISCN	No	No
Unichem	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	203030-003	Oct 14, 2015	AB	RX	No	No
Apotex Corp	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090790-002	Oct 6, 2010		DISCN	No	No
Aiping Pharm Inc	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090544-001	Oct 6, 2010		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

LOSARTAN POTASSIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Losartan Potassium

Introduction

Losartan potassium, a widely used antihypertensive drug, has been experiencing significant market growth and dynamic changes in recent years. This article delves into the market dynamics, financial trajectory, and key factors influencing the losartan potassium market.

Market Size and Growth Projections

The global losartan potassium API market is projected to witness substantial growth from 2023 to 2031. As of 2024, the market size is estimated to be USD 1652.2 million, with a compound annual growth rate (CAGR) of 5.50% anticipated until 2031, reaching USD 2403.42 million[4].

Regional Market Analysis

The market is segmented into several key regions, each with its own growth trajectory:

• North America: Holds the largest market share, with a market size of USD 660.88 million in 2024 and a CAGR of 3.7% from 2024 to 2031[4].
• Europe: Accounts for over 30% of the global revenue, with a market size of USD 495.66 million in 2024 and a CAGR of 4.0% from 2024 to 2031[4].
• Asia-Pacific: Expected to be a key hub for manufacturing and consumption, with a market size of USD 380.01 million in 2024 and a CAGR of 7.5% from 2024 to 2031. This region's growth is driven by a large population, rising rates of hypertension, and increasing healthcare costs[4].
• Latin America and Middle East & Africa: These regions also show promising growth, with Latin America expected to grow at a CAGR of 4.9% and the Middle East & Africa at a CAGR of 5.2% from 2024 to 2031[4].

Market Drivers

Several factors are driving the growth of the losartan potassium market:

• Increasing Demand: Strong demand from the pharmaceutical industry and research institutions is a significant driver. The need for efficient antihypertensive treatments, particularly in regions with high rates of hypertension and cardiovascular disorders, is on the rise[4].
• Government Initiatives: Government measures to improve healthcare access and promote market expansion, especially in the Asia-Pacific region, are contributing to the market's growth[4].
• Affordable Manufacturing: The Asia-Pacific region's affordable manufacturing capabilities are attracting more production of generic drugs, including losartan potassium[4].

Market Restraints

Despite the positive outlook, there are several challenges affecting the market:

• Supply Chain Disruptions: Ongoing supply chain challenges, including port congestion in Asia and conflicts in the Red Sea, are causing delivery delays and insufficient market supply, leading to price surges[2].
• Shipping Costs: Increased shipping costs due to heightened risks and disruptions in global maritime traffic are being passed on to consumers, adding to the rising prices of losartan potassium[2].
• Inventory Replenishment: Companies stockpiling to ensure sufficient inventory amid extended lead times are further amplifying the demand and exerting upward pressure on prices[2].

Market Opportunities

The losartan potassium market presents several opportunities:

• Growing Healthcare Needs: The increasing prevalence of hypertension and cardiovascular diseases globally offers a significant opportunity for the market to expand[4].
• Generic Drug Production: The rise in generic drug production, particularly in regions like the Asia-Pacific, presents a lucrative opportunity for manufacturers[4].
• Global Easing of Monetary Policies: The potential easing of monetary policies could alleviate financial pressures on businesses, supporting the upward trajectory of losartan potassium prices and market growth[2].

Challenges

The market faces several challenges that need to be addressed:

• Price Volatility: Recent price surges due to supply chain disruptions and increased demand have created volatility in the market. This volatility can impact both manufacturers and consumers[2].
• Regulatory Hurdles: Changes in regulatory policies can affect the production, distribution, and pricing of losartan potassium. Manufacturers need to stay compliant with these regulations to maintain market stability[4].

Impact of Supply Chain Disruptions

Supply chain disruptions have been a significant factor in the recent price surge of losartan potassium. Port congestion in Asia, unexpected bad weather, and vessel bunching have resulted in low terminal operation efficiency and prolonged wait times. Additionally, the ongoing conflict in the Red Sea has severely impacted global maritime traffic, leading to increased shipping costs and further price hikes[2].

Financial Impact on Businesses

The financial impact of these disruptions is substantial. Businesses are facing increased costs due to higher shipping expenses and inventory replenishment efforts. However, the global easing of monetary policies could provide some relief by alleviating financial pressures on businesses, thereby supporting the market's growth trajectory[2].

Consumer Demand and Inventory Buildup

Consumer demand for losartan potassium remains strong, driven by both consumer requirements and proactive inventory buildup by retailers. This demand, coupled with extended lead times, has led to a robust restocking phase, particularly during peak seasons, further driving up prices[2].

Clinical Significance and Efficacy

Losartan potassium has been clinically proven to be effective in reducing cardiovascular morbidity and mortality. Studies such as the Losartan Intervention For Endpoint reduction (LIFE) study have shown that losartan is superior to atenolol in treating patients with isolated systolic hypertension and left ventricular hypertrophy (LVH)[5].

Key Takeaways

• The global losartan potassium API market is projected to grow significantly from 2023 to 2031.
• Regional markets, especially Asia-Pacific, are expected to drive substantial growth.
• Supply chain disruptions and increased demand are leading to price surges.
• Government initiatives and affordable manufacturing capabilities are key drivers.
• The market faces challenges such as price volatility and regulatory hurdles.

FAQs

Q: What is the projected market size of the global losartan potassium API market by 2031? A: The global losartan potassium API market is expected to reach USD 2403.42 million by 2031[4].

Q: Which region is expected to have the highest CAGR in the losartan potassium API market? A: The Asia-Pacific region is expected to have the highest CAGR of 7.5% from 2024 to 2031[4].

Q: What are the main factors driving the growth of the losartan potassium market? A: Increasing demand from the pharmaceutical industry, government initiatives, and affordable manufacturing capabilities are key drivers[4].

Q: How have supply chain disruptions affected the losartan potassium market? A: Supply chain disruptions have led to delivery delays, insufficient market supply, and increased shipping costs, resulting in price surges[2].

Q: What is the clinical significance of losartan potassium in treating hypertension? A: Losartan potassium has been shown to be superior to atenolol in reducing cardiovascular morbidity and mortality, particularly in patients with isolated systolic hypertension and LVH[5].

Cited Sources

1. Market Research Intellect: Losartan Potassium API Sales Market Size, Scope And Forecast.
2. ChemAnalyst: Cardiac Care Crunch: Losartan Potassium Prices Surge Worldwide.
3. Market Research Intellect: Marché des comprimés de losartan et de potassium.
4. Cognitive Market Research: Losartan Potassium API Market Report 2024 (Global Edition).
5. JAMA Network: Effects of Losartan on Cardiovascular Morbidity and Mortality in Patients with Isolated Systolic Hypertension and Left Ventricular Hypertrophy.