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Last Updated: December 22, 2024

HYDROCHLOROTHIAZIDE; TRIAMTERENE - Generic Drug Details

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What are the generic sources for hydrochlorothiazide; triamterene and what is the scope of freedom to operate?

Hydrochlorothiazide; triamterene is the generic ingredient in four branded drugs marketed by Glaxosmithkline Llc, Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Norvium Bioscience, Novartis, Sandoz, Vitarine, Aurobindo Pharma Usa, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon, Watson Labs, and Zydus Pharms, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-nine suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TRIAMTERENE

US Patents:	0
Tradenames:	4
Applicants:	18
NDAs:	24
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	5
Patent Applications:	214
DailyMed Link:	HYDROCHLOROTHIAZIDE; TRIAMTERENE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; TRIAMTERENE

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

Sponsor	Phase
University of California, Irvine	Phase 4
West China Hospital	Phase 4
Vanderbilt University	N/A

See all HYDROCHLOROTHIAZIDE; TRIAMTERENE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Drug Class	Potassium-sparing Diuretic Thiazide Diuretic
Physiological Effect	Decreased Renal K+ Excretion Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; TRIAMTERENE

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; TRIAMTERENE

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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
Am Therap	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	072022-001	Apr 17, 1988		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Ani Pharms	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	074259-001	Mar 30, 1995		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Rubicon	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	216211-001	Feb 23, 2022	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; TRIAMTERENE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984	⤷ Subscribe	⤷ Subscribe
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988	⤷ Subscribe	⤷ Subscribe
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

HYDROCHLOROTHIAZIDE; TRIAMTERENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triamterene and Hydrochlorothiazide

Introduction

Triamterene and hydrochlorothiazide are two diuretic medications often combined to treat high blood pressure (hypertension) and edema (fluid retention). This combination is crucial in managing cardiovascular health, and its market dynamics are influenced by several key factors.

Market Drivers

Increasing Prevalence of Hypertension

The global market for triamterene and hydrochlorothiazide is significantly driven by the increasing prevalence of hypertension. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[3].

Geriatric Population Growth

The rise in the geriatric population is another key driver. Older adults are more likely to develop hypertension and related cardiovascular diseases, thereby increasing the demand for these medications[3].

FDA Approvals and New Product Launches

Recent FDA approvals and the launch of new generic versions of triamterene and hydrochlorothiazide have expanded market accessibility. For instance, in August 2020, Schein launched a generic version of hydrochlorothiazide/triamterene, manufactured by Bolar Pharmaceutical[3].

Healthcare Expenditure and Research & Development

Increased healthcare expenditure and robust research & development activities by pharmaceutical companies also propel market growth. These investments lead to the development of novel drugs and improved treatment options, further boosting the market[3].

Market Restraints

Side Effects and Safety Concerns

Despite the growing demand, the market is hampered by side effects associated with hydrochlorothiazide, such as frequent urination, headache, and the risk of hypokalemia (low potassium levels). These side effects can deter some patients and healthcare providers from using this combination[5].

Market Trends

New Product Launches

The market has seen several new product launches that combine hydrochlorothiazide with other antihypertensive drugs. For example, Beximco Pharmaceuticals Ltd. launched Telma Plus, which combines hydrochlorothiazide with telmisartan, an angiotensin II antagonist[3].

Generic Versions

The introduction of generic versions of triamterene and hydrochlorothiazide has increased market competition and made these medications more affordable for a wider population. This trend is expected to continue, driving market growth[3].

Regional Analysis

The global triamterene and hydrochlorothiazide market is segmented by region, with significant demand coming from regions with high prevalence rates of hypertension. Economically developing nations are expected to dominate the market growth due to increasing awareness and access to healthcare services[1].

Competitor Analysis

The market is highly competitive, with several key players such as Beijing Second Pharmaceutical, Torrent Pharmaceuticals, Zhejiang Huahai Pharmaceutical, Teva, and Aurobindo Pharma. These companies are involved in extensive research and development, manufacturing, and distribution of triamterene and hydrochlorothiazide[3].

Financial Trajectory

Revenue and Growth Rate

The market for triamterene and hydrochlorothiazide is expected to grow significantly over the forecast period from 2025 to 2031. The increasing prevalence of hypertension and the launch of new products are key factors driving this growth. The compound annual growth rate (CAGR) is anticipated to be substantial, reflecting the rising demand for these medications[1].

Capital Investment and Operating Costs

Setting up a manufacturing plant for triamterene and hydrochlorothiazide requires significant capital investment, including costs for raw materials, utilities, labor, packaging, and machinery. The operating costs also include recurring expenses such as maintenance, utilities, and labor. A detailed analysis of these costs is crucial for investors and manufacturers to ensure profitability[4].

Pricing Strategies and Profit Margins

The pricing of triamterene and hydrochlorothiazide is influenced by market competition, regulatory frameworks, and the availability of generic versions. Manufacturers need to balance pricing strategies to ensure profitability while keeping the medication accessible to a wide range of patients. Projected profit margins are expected to be favorable due to the high demand and limited competition in certain regions[4].

Technological Trends and Manufacturing Process

The manufacturing process of triamterene and hydrochlorothiazide involves the synthesis of both active pharmaceutical ingredients (APIs) separately, followed by their formulation into a combined dosage form. Technological advancements in the manufacturing process, such as process optimization techniques, are crucial for reducing costs and improving efficiency[4].

Regulatory Frameworks and Sustainability

Regulatory frameworks play a significant role in the triamterene and hydrochlorothiazide market. Compliance with FDA regulations and other international standards is essential for market approval. Additionally, sustainability measures and environmental impact assessments are becoming increasingly important for pharmaceutical manufacturers[4].

Consumer Behavior and Awareness

Consumer awareness about the importance of blood pressure management is a key driver of the market. Patients are becoming more informed about their treatment options, and this increased awareness fuels the demand for effective medications like triamterene and hydrochlorothiazide[4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the market. While it has presented challenges in the supply chain, it has also highlighted the importance of cardiovascular health, leading to increased demand for medications that manage hypertension and related conditions[3].

"Currently, around 115 vaccine candidates and 155 molecules are in the R&D pipeline. Moreover, commonly used drugs such as hydroxychloroquine have witnessed a dramatic surge in demand for the management of COVID-19."[3]

Key Takeaways

The market for triamterene and hydrochlorothiazide is driven by the increasing prevalence of hypertension and the growing geriatric population.
New product launches and FDA approvals are expanding market accessibility.
Side effects and safety concerns are significant restraints.
The market is expected to grow substantially over the forecast period.
Capital investment and operating costs are critical for manufacturers.
Technological advancements and regulatory compliance are essential for market success.

Frequently Asked Questions (FAQs)

Q: What is the primary use of the combination medication triamterene and hydrochlorothiazide? A: The combination medication triamterene and hydrochlorothiazide is used to treat high blood pressure (hypertension) and edema (fluid retention)[2].

Q: How do triamterene and hydrochlorothiazide work? A: Triamterene acts as a potassium-sparing diuretic, while hydrochlorothiazide is a thiazide diuretic that promotes sodium and water excretion, effectively lowering blood pressure[2].

Q: What are the common side effects of triamterene and hydrochlorothiazide? A: Common side effects include frequent urination, headache, and the risk of hypokalemia (low potassium levels)[5].

Q: Which regions are expected to dominate the market for triamterene and hydrochlorothiazide? A: Economically developing nations are expected to dominate the market growth due to increasing awareness and access to healthcare services[1].

Q: What is the impact of the COVID-19 pandemic on the market for triamterene and hydrochlorothiazide? A: The pandemic has highlighted the importance of cardiovascular health, leading to increased demand for medications that manage hypertension and related conditions, despite supply chain challenges[3].

Cited Sources:

Cognitivemarketresearch.com: Global Triamterene Hydrochlorothiazide Market Report 2024 Edition.
Mayoclinic.org: Triamterene and hydrochlorothiazide (oral route).
Alliedmarketresearch.com: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030).
Expertmarketresearch.com: Triamterene Hydrochlorothiazide Manufacturing Plant Project Report 2024 Edition.
Medlineplus.gov: Triamterene and Hydrochlorothiazide: MedlinePlus Drug Information.

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