Hydrochlorothiazide; valsartan - Generic Drug Details

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

Hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for hydrochlorothiazide; valsartan

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	43
Patent Applications:	446
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydrochlorothiazide; valsartan
DailyMed Link:	hydrochlorothiazide; valsartan at DailyMed

Recent Clinical Trials for hydrochlorothiazide; valsartan

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

Sponsor	Phase
Farma de Colombia SA	Phase 3
Damanhour University	N/A
Tehran University of Medical Sciences	Phase 3

See all hydrochlorothiazide; valsartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; VALSARTAN

Applicant	Application No.	Strength	Dosage Form
		25MG;320MG	TABLET;ORAL
		12.5MG;320MG	TABLET;ORAL
		25MG;160MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrochlorothiazide; valsartan

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; valsartan

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	320 mg/12.5 mg and 320 mg/25 mg	020818	1	2007-02-07
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg	020818	1	2005-12-02

US Patents and Regulatory Information for hydrochlorothiazide; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	201662-005	Mar 21, 2013	AB	RX	No	No
Watson Labs Teva	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	091519-004	Mar 21, 2013		DISCN	No	No
Lupin Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	078946-003	Mar 21, 2013	AB	RX	No	No

Expired US Patents for hydrochlorothiazide; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006

Hydrochlorothiazide; valsartan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Valsartan and Hydrochlorothiazide

Introduction

The combination of valsartan and hydrochlorothiazide is a widely used medication for treating hypertension, a condition that affects a significant portion of the global population. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of these drugs.

Market Overview

Global Market Size and Growth

The global market for valsartan and hydrochlorothiazide is experiencing significant growth. The valsartan market, for instance, was estimated to be worth US$ 589 million in 2023 and is forecasted to reach US$ 866.2 million by 2030, with a compound annual growth rate (CAGR) of 6.4% during the forecast period of 2024-2030[4].

Segment Analysis

The market for valsartan and hydrochlorothiazide can be segmented by type, application, and region.

• Type: The market is segmented into different dosage forms and combinations. For example, the 80mg/12.5mg segment of valsartan hydrochlorothiazide accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[1].
• Application: These drugs are primarily used in the treatment of hypertension, heart failure, and other cardiovascular conditions. The hospital segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[1].
• Region: The market is analyzed across major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides revenue share, current trends, and future market opportunities[1].

Key Drivers

Increasing Prevalence of Hypertension

The rising number of patients suffering from hypertension globally is a major driver for the market growth of both valsartan and hydrochlorothiazide. According to the World Health Organization (WHO), approximately 1.13 billion people suffer from hypertension, and this prevalence is expected to increase to 29% by 2025, driven largely by increases in economically developing nations[3].

Geriatric Population and Healthcare Expenditure

The increase in the geriatric population and the rise in healthcare expenditure are significant factors boosting the market growth. Older adults are more likely to suffer from hypertension and other cardiovascular diseases, leading to an increased demand for these medications[3].

Research and Development

Pharmaceutical companies are actively involved in research and development activities, leading to the launch of novel and generic versions of these drugs. For example, in 2020, Schein launched a generic version of hydrochlorothiazide/triamterene, and Beximco Pharmaceuticals launched Telma Plus, which contains hydrochlorothiazide and telmisartan[3].

Market Restraints

Side Effects and Adverse Reactions

Despite the growth drivers, the market faces restraints due to the side effects associated with these medications. Increasing the dose of valsartan from 160 mg to 320 mg, for instance, provides marginal additional blood pressure reduction but increases the risk of adverse reactions[2].

Regulatory Considerations

The use of valsartan with hydrochlorothiazide or amlodipine is restricted for people with hypertension not controlled by monotherapy, which can limit market expansion. These combinations are listed on the Pharmaceutical Benefits Scheme (PBS) as restricted benefits[2].

Financial Trajectory

Revenue Forecast

The global valsartan market is forecasted to grow from US$ 589 million in 2023 to US$ 866.2 million by 2030, with a CAGR of 6.4% during the forecast period. The hydrochlorothiazide market is also expected to grow significantly, driven by the increasing prevalence of hypertension and other cardiovascular diseases[3][4].

Competitive Landscape

The market is highly competitive with several key players such as Novartis, Lupin, Teva, Mylan, Alembic Pharmaceuticals, and Aurobindo Pharma. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business in the global market[1][4].

Regional Analysis

North America and Europe

These regions are significant contributors to the global market due to high healthcare expenditure and a large patient base suffering from hypertension. However, the Asia Pacific region is expected to show rapid growth due to the increasing prevalence of cardiovascular diseases and growing healthcare infrastructure[1].

Emerging Markets

Latin America and the Middle East & Africa are emerging markets with potential for growth. These regions are experiencing an increase in the number of patients with hypertension, driven by lifestyle changes and economic development[1].

Technological and Regulatory Trends

Fixed-Dose Combinations

Fixed-dose combination therapy, such as valsartan with hydrochlorothiazide or amlodipine, is becoming more popular due to its convenience and cost-effectiveness. This trend is expected to continue, driven by patient compliance and healthcare cost management[2].

COVID-19 Impact

The COVID-19 pandemic has presented both challenges and opportunities for the pharmaceutical industry. While it has disrupted supply chains, it has also accelerated the development and approval of new drugs, including those for hypertension management[3].

Consumer Behavior and Preferences

Patient Compliance

Patients prefer fixed-dose combinations as they reduce the number of tablets to be taken daily, improving compliance. This preference is driving the market towards more convenient and patient-friendly formulations[2].

Cost Considerations

The cost of medication is a significant factor influencing patient choices. Combination therapies often require only one co-payment, making them more affordable for patients[2].

Key Takeaways

• The global market for valsartan and hydrochlorothiazide is driven by the increasing prevalence of hypertension and other cardiovascular diseases.
• The market is expected to grow significantly, with a CAGR of 6.4% for valsartan from 2024 to 2030.
• Key players are focusing on research and development to launch new and generic versions of these drugs.
• Regulatory considerations and side effects are significant restraints to market growth.
• Fixed-dose combinations and patient compliance are key trends shaping the market.

FAQs

What is the primary use of the combination of valsartan and hydrochlorothiazide?

The combination of valsartan and hydrochlorothiazide is primarily used to treat high blood pressure (hypertension) and can be used alone or with other medicines[5].

How does valsartan work to lower blood pressure?

Valsartan is an angiotensin II receptor blocker (ARB) that works by blocking a substance in the body that causes blood vessels to tighten, thereby relaxing the blood vessels and lowering blood pressure[5].

What are the potential side effects of increasing the dose of valsartan?

Increasing the dose of valsartan from 160 mg to 320 mg provides marginal additional blood pressure reduction but increases the risk of adverse reactions[2].

Which regions are expected to show rapid growth in the market for valsartan and hydrochlorothiazide?

The Asia Pacific region is expected to show rapid growth due to the increasing prevalence of cardiovascular diseases and growing healthcare infrastructure[1].

How has the COVID-19 pandemic impacted the market for these drugs?

The COVID-19 pandemic has accelerated the development and approval of new drugs, including those for hypertension management, but has also disrupted supply chains[3].

Sources

1. Global Valsartan Hydrochlorothiazide Market Report 2024 Edition - Cognitivemarketresearch.com
2. Valsartan with hydrochlorothiazide (Co-Diovan) or amlodipine (Exforge) - Nps.org.au
3. Hydrochlorothiazide Market Size | Industry Growth, (2021-2030) - Alliedmarketresearch.com
4. Valsartan Drug - Market Size - Valuates Reports - Valuates.com
5. Valsartan and hydrochlorothiazide (oral route) - Mayo Clinic - Mayoclinic.org