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Last Updated: December 22, 2024

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE - Generic Drug Details

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

Hydrochlorothiazide; metoprolol tartrate is the generic ingredient in two branded drugs marketed by Validus Pharms, Alembic, Mylan, and Sun Pharm Inds, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	5
Clinical Trials:	3
DailyMed Link:	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Vanderbilt University Medical Center	Phase 1
Vanderbilt University	Phase 1

See all HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Drug Class	Thiazide Diuretic beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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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
Alembic	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	202870-001	Nov 6, 2013	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alembic	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	202870-002	Nov 6, 2013	AB	RX	No	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mylan	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	076792-001	Aug 20, 2004	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mylan	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	076792-003	Aug 20, 2004	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Sun Pharm Inds	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	090654-003	Jan 19, 2012		DISCN	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; METOPROLOL TARTRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	⤷ Subscribe	⤷ Subscribe
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	⤷ Subscribe	⤷ Subscribe
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	⤷ Subscribe	⤷ Subscribe
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	⤷ Subscribe	⤷ Subscribe
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	⤷ Subscribe	⤷ Subscribe
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metoprolol Tartrate and Hydrochlorothiazide

Introduction

Metoprolol tartrate and hydrochlorothiazide are widely used medications, particularly for the treatment of hypertension and other cardiovascular conditions. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global metoprolol tartrate market is projected to experience significant growth over the coming years. By 2027, the market size is estimated to reach $868.3 million, growing at a CAGR of 5.2% during the forecast period 2022-2027[1].

On a broader scale, the global metoprolol tartrate market was valued at USD 6,553.01 million in 2023 and is expected to reach USD 8,805.36 million by 2031, with a CAGR of 3.8% during the forecast period 2024-2031[3].

Drivers of Market Growth

Several factors are driving the growth of the metoprolol tartrate market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of hypertension and other cardiovascular diseases is a major driver. For instance, according to the Centers for Disease Control and Prevention (CDC), approximately 47.3% of the adult population in the U.S. suffered from hypertension in 2019, which is around 116 million people[4].

Product Launches and Innovations

The increasing number of product launches by market players is another significant factor. For example, Mylan N.V. launched Metoprolol Tartrate Tablets USP in new strengths, expanding the available options for patients[4].

COVID-19 Impact

The COVID-19 pandemic has also contributed to the market growth, as research has explored the use of metoprolol tartrate in treating cardiovascular complications associated with COVID-19. Studies have shown that intravenous metoprolol administration can be safe and effective in reducing lung inflammation in COVID-19 patients[4].

Geographical Analysis

The market is geographically segmented, with different regions exhibiting varying growth rates:

North America

North America holds the largest market share, primarily due to the high prevalence of heart diseases in this region. In 2021, North America accounted for the highest revenue share and is expected to continue dominating the market during the forecast period[1][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing segment, driven by the increasing application of metoprolol tartrate for treating hypertension and angina. This growth is also fueled by regional investments in healthcare[1][3].

Route of Administration and Distribution Channels

The market is segmented based on the route of administration and distribution channels:

Route of Administration

Oral administration dominates the market due to the growing demand for tablets. However, injectable forms are also gaining traction, particularly for acute myocardial infarction treatment[1][3].

Distribution Channels

Hospitals, retail pharmacies, and online pharmacies are the primary distribution channels. The convenience and accessibility of these channels contribute to the market's growth[3].

Challenges and Restraints

Despite the growth, there are several challenges and restraints:

Side Effects and Adverse Reactions

The rising side effects of metoprolol tartrate, such as bradycardia, hypotension, and electrolyte imbalances, are significant concerns. These side effects can limit the market growth[2].

Government Regulations

Stringent government regulations on pharmaceuticals can also hamper the market. For instance, the FDA's guidelines and regulatory frameworks can impact the approval and marketing of metoprolol tartrate products[5].

Healthcare System Reimbursement

Reimbursement policies and healthcare system constraints can also pose challenges to the market growth. Ensuring adequate reimbursement for metoprolol tartrate treatments is crucial for maintaining market momentum[3].

Patient Education and Adherence

Patient education and adherence programs are critical for improving patient outcomes and loyalty. Pharmaceutical companies and healthcare providers have opportunities to invest in these programs, which can enhance the market's overall performance[3].

Collaboration with Healthcare Providers

Building collaborative relationships with healthcare providers can help pharmaceutical companies secure preferred formulary status for metoprolol tartrate, ensuring its inclusion in treatment protocols and driving market growth[3].

Dosage and Administration

The dosage and administration of metoprolol tartrate and hydrochlorothiazide are crucial for their effectiveness. The usual dose range for metoprolol tartrate is 100 mg to 400 mg per day, often combined with hydrochlorothiazide in doses of 12.5 mg to 50 mg per day. Proper administration, such as with or immediately following meals, is recommended to maintain the full effect of the medication[2].

Key Takeaways

The global metoprolol tartrate market is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases.
North America dominates the market, but the Asia-Pacific region is expected to show the fastest growth.
Product launches, innovations, and the impact of the COVID-19 pandemic are key drivers.
Side effects, government regulations, and healthcare reimbursement policies are significant challenges.
Patient education and collaboration with healthcare providers are essential for market growth.

FAQs

Q: What is the projected market size of metoprolol tartrate by 2027? A: The metoprolol tartrate market is estimated to reach $868.3 million by 2027[1].

Q: What are the primary drivers of the metoprolol tartrate market growth? A: The primary drivers include the increasing prevalence of cardiovascular diseases, product launches, and the impact of the COVID-19 pandemic[1][4].

Q: Which region dominates the metoprolol tartrate market? A: North America holds the largest market share due to the high prevalence of heart diseases in this region[1][4].

Q: What are the common side effects of metoprolol tartrate? A: Common side effects include bradycardia, hypotension, and electrolyte imbalances such as hypokalemia and hyponatremia[2].

Q: How does the COVID-19 pandemic impact the metoprolol tartrate market? A: The pandemic has driven research into using metoprolol tartrate for treating cardiovascular complications associated with COVID-19, contributing to market growth[4].

Cited Sources:

IndustryARC: Metoprolol Tartrate Market Size Report, 2022-2027.
DailyMed: Metoprolol Tartrate and Hydrochlorothiazide tablet.
Data Bridge Market Research: Global Metoprolol Tartrate Market Size, Evaluating Share & Forecast By 2031.
Coherent Market Insights: Metoprolol Tartrate Market Size, Trends and Forecast to 2030.
FDA: Draft Guidance on Metoprolol Tartrate; Hydrochlorothiazide.

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