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Last Updated: December 22, 2024

Hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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

Hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in three branded drugs marketed by Cosette, Alkem Labs Ltd, Accord Hlthcare, Alembic, Aurobindo Pharma, Macleods Pharms Ltd, Natco Pharma Usa, Prinston Inc, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for hydrochlorothiazide; olmesartan medoxomil

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	12
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydrochlorothiazide; olmesartan medoxomil
DailyMed Link:	hydrochlorothiazide; olmesartan medoxomil at DailyMed

Recent Clinical Trials for hydrochlorothiazide; olmesartan medoxomil

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

Sponsor	Phase
Altasciences Company Inc.	Phase 1
Pharmtechnology LLC	Phase 1
Altasciences Company, Inc.	Phase 1

See all hydrochlorothiazide; olmesartan medoxomil clinical trials

Pharmacology for hydrochlorothiazide; olmesartan medoxomil

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; olmesartan medoxomil

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	20 mg/12.5 mg	021532	1	2007-05-11
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	40 mg/12.5 mg and 40 mg/25 mg	021532	1	2007-02-15

US Patents and Regulatory Information for hydrochlorothiazide; olmesartan medoxomil

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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
Aurobindo Pharma	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	205391-003	Apr 24, 2017	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Aurobindo Pharma	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	205391-002	Apr 24, 2017	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alkem Labs Ltd	HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	207037-001	Jul 11, 2024	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; olmesartan medoxomil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	5,616,599*PED	⤷ Subscribe
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	5,616,599*PED	⤷ Subscribe
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	6,878,703*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Hydrochlorothiazide; olmesartan medoxomil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Olmesartan Medoxomil

Introduction

Hydrochlorothiazide and Olmesartan Medoxomil are widely used in the treatment of hypertension, combining the diuretic properties of hydrochlorothiazide with the angiotensin II receptor antagonist properties of olmesartan medoxomil. This combination therapy has become a staple in managing blood pressure, and its market dynamics are influenced by several key factors.

Market Size and Growth

The market for Olmesartan Medoxomil and Hydrochlorothiazide tablets is substantial and growing. According to market research, the global market for similar antihypertensive combinations, such as Amlodipine and Olmesartan, was valued at USD 597.95 million in 2023 and is projected to reach USD 824.65 million by 2031, growing at a CAGR of 4.10% from 2024 to 2031[3].

Demand Drivers

Rising Hypertension Prevalence

The increasing global incidence of hypertension is a significant driver for this market. The World Health Organization (WHO) estimates that approximately 1.28 billion adults aged 30-79 worldwide have hypertension, a number expected to rise[3].

Combination Therapy Preference

Healthcare providers increasingly prefer combination therapies to achieve better blood pressure control with fewer side effects. The synergistic effect of Olmesartan Medoxomil and Hydrochlorothiazide makes this combination a preferred choice for clinicians and patients[3].

Increasing Geriatric Population

The global geriatric population, projected to reach 1.5 billion by 2050, is at a higher risk for hypertension. This demographic shift drives the demand for antihypertensive medications tailored for older adults[3].

Advancements in Drug Formulations

Innovations in drug delivery systems, such as fixed-dose combinations, enhance patient compliance and treatment efficacy. These advancements support the expansion of the market as they facilitate easier administration and improve patient outcomes[3].

Regional Market Analysis

North America

North America is a dominant region in the market, driven by a robust healthcare infrastructure, high prevalence of hypertension, and increased awareness of cardiovascular diseases. The United States and Canada contribute significantly to market growth due to the presence of well-established pharmaceutical companies and advanced research and development facilities[3].

Asia Pacific

The Asia Pacific region is the fastest-growing market, driven by rapid urbanization, rising disposable incomes, and increasing awareness of health and wellness. Countries like India and China are experiencing significant growth due to the rising prevalence of lifestyle-related diseases, including hypertension[3].

Competitive Landscape

The market for Olmesartan Medoxomil and Hydrochlorothiazide is competitive, with several major manufacturers producing both original and generic versions of the drug. The entry of generic versions poses a significant challenge to branded products, leading to price erosion and reduced profit margins[1].

Financial Trajectory

Revenue Growth

The global revenue for Olmesartan Medoxomil and Hydrochlorothiazide tablets is expected to grow steadily. For instance, the revenue from similar antihypertensive combinations is projected to increase from USD 597.95 million in 2023 to USD 824.65 million by 2031[3].

Pricing and Cost Factors

The pricing of Olmesartan Medoxomil and Hydrochlorothiazide tablets can vary by region and application. The cost of these medications is influenced by factors such as production costs, regulatory approvals, and reimbursement policies. Economic instability and healthcare budget constraints can affect drug pricing and access, particularly in low- and middle-income countries[3].

Clinical Trials and Safety

Clinical trials have shown that the combination of Olmesartan Medoxomil and Hydrochlorothiazide is well-tolerated, with an incidence of adverse events similar to that of placebo. Common adverse reactions include nausea, hyperuricemia, dizziness, and upper respiratory infections. The overall safety profile supports its widespread use in hypertension management[4].

Challenges

Generic Competition

The entry of generic versions of Olmesartan Medoxomil and Hydrochlorothiazide is a significant challenge, as it can lead to reduced market share and profit margins for branded products[3].

Adverse Drug Reactions

Potential side effects, such as dizziness, swelling, or gastrointestinal issues, may deter some patients from continuing their prescribed treatment, impacting market demand[3].

Regulatory Hurdles

The approval process for new formulations and combination therapies can be lengthy and complex, delaying the introduction of innovative products and limiting growth opportunities[3].

Key Takeaways

The market for Olmesartan Medoxomil and Hydrochlorothiazide is driven by rising hypertension prevalence, preference for combination therapies, and an increasing geriatric population.
North America and the Asia Pacific region are key markets due to their robust healthcare infrastructure and growing awareness of cardiovascular diseases.
The financial trajectory is positive, with projected revenue growth driven by advancements in drug formulations and increasing demand.
Challenges include generic competition, adverse drug reactions, and regulatory hurdles.

FAQs

Q: What is the primary indication for Olmesartan Medoxomil and Hydrochlorothiazide?

A: The primary indication for Olmesartan Medoxomil and Hydrochlorothiazide is the treatment of hypertension to lower blood pressure[4].

Q: How does the combination of Olmesartan Medoxomil and Hydrochlorothiazide work?

A: Olmesartan Medoxomil is an angiotensin II receptor antagonist that prevents blood vessel constriction, while Hydrochlorothiazide is a diuretic that helps reduce blood pressure by increasing urine production[4].

Q: What are the common adverse reactions associated with Olmesartan Medoxomil and Hydrochlorothiazide?

A: Common adverse reactions include nausea, hyperuricemia, dizziness, and upper respiratory infections[4].

Q: How does the entry of generic versions affect the market for Olmesartan Medoxomil and Hydrochlorothiazide?

A: The entry of generic versions can lead to price erosion and reduced profit margins for branded products, posing a significant challenge to market growth[3].

Q: What regions are expected to drive the growth of the Olmesartan Medoxomil and Hydrochlorothiazide market?

A: North America and the Asia Pacific region are expected to drive market growth due to their robust healthcare infrastructure and increasing awareness of cardiovascular diseases[3].

Sources

QYResearch: Global Olmesartan Medoxomil Hydrochlorothiazide Tablets Market Report.
Science.gov: Topics related to Hydrochlorothiazide and Olmesartan Medoxomil.
Verified Market Research: Amlodipine And Olmesartan Market Size, Share, Trends & Forecast.
Drugs.com: Olmesartan Medoxomil and Hydrochlorothiazide: Package Insert.

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