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Last Updated: December 22, 2024

Hydrochlorothiazide; losartan potassium - Generic Drug Details

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

Hydrochlorothiazide; losartan potassium is the generic ingredient in two branded drugs marketed by Organon, Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-one suppliers are listed for this compound.

Summary for hydrochlorothiazide; losartan potassium

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Finished Product Suppliers / Packagers:	31
Clinical Trials:	15
DailyMed Link:	hydrochlorothiazide; losartan potassium at DailyMed

Recent Clinical Trials for hydrochlorothiazide; losartan potassium

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Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
Kyushu University	Phase 3
Federico II University	Phase 4

See all hydrochlorothiazide; losartan potassium clinical trials

Pharmacology for hydrochlorothiazide; losartan potassium

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; losartan potassium

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	100 mg/12.5 mg	020387	1	2006-04-04
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	50 mg/12.5 mg and 100 mg/25 mg	020387	1	2004-05-24

US Patents and Regulatory Information for hydrochlorothiazide; losartan potassium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	218015-003	Sep 29, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Granules	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	218015-002	Sep 29, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alembic Pharms Ltd	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	091617-001	Feb 17, 2012	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for hydrochlorothiazide; losartan potassium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	5,608,075*PED	⤷ Subscribe
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005	5,138,069*PED	⤷ Subscribe
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	5,608,075	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Hydrochlorothiazide; losartan potassium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Losartan Potassium

Introduction to Hydrochlorothiazide and Losartan Potassium

Hydrochlorothiazide and losartan potassium are two widely used medications in the treatment of hypertension and related cardiovascular conditions. Understanding their market dynamics and financial trajectories is crucial for stakeholders in the pharmaceutical industry.

Hydrochlorothiazide Market Overview

Market Size and Growth

The hydrochlorothiazide market is expected to see significant growth from 2021 to 2030. The increasing prevalence of hypertension, which affects approximately 1.13 billion people globally and is projected to rise to 29% by 2025, drives this growth[4].

Key Drivers

Increasing Geriatric Population: The rise in the elderly population, who are more prone to hypertension and other cardiovascular diseases, boosts the demand for hydrochlorothiazide[1][4].
FDA Approvals and Research: The increase in FDA approvals for new drugs and ongoing research activities by pharmaceutical companies further propel the market growth[1][4].
Healthcare Expenditure: Rising healthcare expenditure and increased awareness for the treatment of heart diseases also contribute to the market's expansion[1].

Market Segmentation

By Type: Hydrochlorothiazide is available in various forms such as tablets, capsules, and liquids[4].
By Application: It is used to treat hypertension, fluid retention, heart attacks, kidney failure, and other conditions[4].
By End User: The primary end users include hospitals, drug stores, and other healthcare facilities[4].

Challenges

Despite the growth, the hydrochlorothiazide market faces challenges such as side effects associated with the medication, which can hamper its growth[1].

Losartan Potassium Market Overview

Market Size and Growth

The global losartan potassium API market is estimated to be USD 1652.2 million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 5.50% from 2024 to 2031[2].

Key Drivers

Increasing Demand in Asia-Pacific: The Asia-Pacific region, with its large population and rising rates of high blood pressure and cardiovascular disorders, is expected to witness substantial growth. Factors such as rapid urbanization, changing lifestyles, and rising disposable incomes contribute to this trend[2][5].
Healthcare Access and Government Initiatives: Government measures to improve healthcare access and promote market expansion in the Asia-Pacific region also drive the market[2].
Research and Development: Ongoing research and development activities, along with the launch of novel drugs, are key drivers for the losartan potassium market[5].

Market Segmentation

By Region: The market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. North America currently dominates the market, but Asia-Pacific is expected to show the highest CAGR[2][5].
By Application: Losartan potassium is primarily used to treat hypertension and reduce the risk of stroke in patients with high blood pressure and heart enlargement[3].

Financial Trajectory

The losartan potassium API market is projected to expand significantly, with North America holding a major market share of over 40% and Europe holding around 30% of the global revenue in 2024. The Asia-Pacific region, with a market share of around 23%, is expected to grow at a CAGR of 7.5% from 2024 to 2031[2].

Comparative Analysis of Market Dynamics

Similar Drivers

Both markets are driven by the increasing prevalence of hypertension and cardiovascular diseases. The rise in the geriatric population and increased healthcare expenditure are common factors boosting both markets[1][4][5].

Regional Focus

While the hydrochlorothiazide market is also influenced by global trends, the losartan potassium market is particularly strong in the Asia-Pacific region due to its large population and growing healthcare needs[2][5].

Challenges and Opportunities

Both markets face challenges related to side effects and the need for continuous research and development. However, the opportunities in emerging markets and the growing demand for antihypertensive treatments present significant growth potential[1][2].

Financial Projections

Hydrochlorothiazide

The detailed financial projections for the hydrochlorothiazide market indicate a steady growth trajectory driven by increasing demand and new FDA approvals. However, specific financial figures for the market size and CAGR are not provided in the available sources.

Losartan Potassium

The losartan potassium API market is expected to grow from USD 1652.2 million in 2024 to USD 2403.42 million by 2031, with a CAGR of 5.50% during this period. The Asia-Pacific region is anticipated to be a key driver of this growth, with a CAGR of 7.5% from 2024 to 2031[2].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including the markets for hydrochlorothiazide and losartan potassium. The increased demand for COVID-19 management drugs has presented opportunities for manufacturers, but it has also highlighted supply chain challenges and the need for robust healthcare systems[1].

Key Takeaways

Growing Demand: Both hydrochlorothiazide and losartan potassium markets are driven by the increasing prevalence of hypertension and cardiovascular diseases.
Regional Growth: The Asia-Pacific region is a key growth area for losartan potassium due to its large population and growing healthcare needs.
Challenges: Side effects and the need for continuous research and development are common challenges for both markets.
Financial Trajectory: The losartan potassium API market is projected to grow at a CAGR of 5.50% from 2024 to 2031, with significant growth expected in the Asia-Pacific region.

FAQs

Q: What are the primary drivers of the hydrochlorothiazide market?

The primary drivers include the increasing prevalence of hypertension, the rise in the geriatric population, and increased healthcare expenditure.

Q: How is the losartan potassium API market expected to grow?

The losartan potassium API market is expected to grow at a CAGR of 5.50% from 2024 to 2031, reaching USD 2403.42 million by 2031.

Q: Which region is expected to show the highest growth in the losartan potassium market?

The Asia-Pacific region is expected to show the highest growth, driven by its large population and increasing healthcare needs.

Q: What are the common challenges faced by both the hydrochlorothiazide and losartan potassium markets?

Both markets face challenges related to side effects and the need for continuous research and development.

Q: How has the COVID-19 pandemic impacted these markets?

The COVID-19 pandemic has presented opportunities for manufacturers due to increased demand for COVID-19 management drugs but has also highlighted supply chain challenges.

Sources

Allied Market Research - Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
Cognitive Market Research - Losartan Potassium API Market Report 2024 (Global Edition)
Mayo Clinic - Losartan and hydrochlorothiazide (oral route) - Mayo Clinic
EIN Presswire - Hydrochlorothiazide Market To See Incredible Growth During 2021–2030
Cognitive Market Research - The global Losartan market size will be USD 1625.5 million in 2024.

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