BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Bisoprolol fumarate; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Novitium Pharma, Teva, Unichem, Watson Labs Teva, and Teva Branded Pharm, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	13
DailyMed Link:	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE at DailyMed

Pharmacology for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

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

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Edenbridge Pharms	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	212678-003	Jul 9, 2020	AB	RX	No	No
Edenbridge Pharms	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	212678-002	Jul 9, 2020	AB	RX	No	No
Apothecon	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	075642-002	Dec 27, 2000		DISCN	No	No

Expired US Patents for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-003	Mar 26, 1993
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-002	Mar 26, 1993
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-001	Mar 26, 1993

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Bisoprolol Fumarate and Hydrochlorothiazide: Market Dynamics and Financial Trajectory

Introduction

Bisoprolol fumarate and hydrochlorothiazide, often combined in a single formulation, are widely used antihypertensive agents. This article delves into the market dynamics, financial trajectory, and key trends influencing the bisoprolol market.

Market Size and Growth

The bisoprolol market has experienced significant growth in recent years. As of 2023, the market size was valued at $1.84 billion and is projected to reach $2 billion in 2024, with a compound annual growth rate (CAGR) of 8.6%[1][4].

By 2028, the market is expected to grow to $2.8 billion at a CAGR of 8.7%, driven by factors such as the expansion of cardiovascular specialty clinics, increased access to patient support programs, a rise in lifestyle-related diseases, and heightened funding for cardiovascular health initiatives[1][4].

Long-Term Projections

Looking ahead to 2031, the bisoprolol market is forecasted to reach $3.51 billion, growing at a CAGR of 4.5% from 2024 to 2031. This growth is supported by an increasing number of working populations and a rising incidence of cardiovascular diseases[3].

Key Drivers of Market Growth

Several factors are driving the growth of the bisoprolol market:

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases, such as hypertension, coronary heart disease, and angina pectoris, is a significant driver. These conditions require long-term management, which boosts the demand for bisoprolol[1][3][4].

Aging Population

An aging population contributes to the growth, as older individuals are more likely to develop cardiovascular diseases that require medication like bisoprolol[1][4].

Improved Access to Generic Medications

The availability of generic formulations of bisoprolol has made the drug more accessible and affordable, contributing to market growth[1][4].

Increased Healthcare Spending

Rising healthcare expenditure and greater funding for cardiovascular health programs also support the market's expansion[1][4].

Market Segmentation

The bisoprolol market is segmented in several ways:

By Type

The market is segmented into tablets and capsules, with tablets being the more common form due to their ease of administration and stability[4].

By Distribution Channels

Bisoprolol is distributed through hospital pharmacies, retail pharmacies, and other distribution channels. Hospital pharmacies often have a higher market share due to the direct prescription and dispensing of medications to patients[4].

By Application

The primary applications include high blood pressure, coronary heart disease, and angina pectoris. High blood pressure is the most significant segment, given the widespread nature of hypertension[3][4].

Regional Analysis

Geographically, the market is divided into North America, Europe, Asia Pacific, and the rest of the world. North America is expected to hold the largest market share due to the high concentration of cardiovascular diseases in this region[3][4].

Innovations and Trends

Several trends are shaping the bisoprolol market:

Innovations in Drug Delivery Systems

Developments in drug delivery systems, such as extended-release formulations, are enhancing patient adherence and long-term control of hypertension. For example, Zydus Lifesciences Limited received FDA approval for its extended-release bisoprolol fumarate and hydrochlorothiazide tablets in 2022[1].

Patient-Centric Therapies

The development of therapies focused on patient needs is another key trend. These therapies aim to improve the efficacy and safety of bisoprolol, making it more patient-friendly[1][4].

Integration of Artificial Intelligence

The integration of artificial intelligence in drug development is expected to streamline the process, improve drug efficacy, and reduce costs[1][4].

Advancements in Cardiovascular Diagnostics

Improvements in cardiovascular diagnostics are helping in the early detection and management of cardiovascular diseases, further boosting the demand for bisoprolol[1][4].

Efficacy and Safety

Studies have shown that the combination of bisoprolol and hydrochlorothiazide is highly effective in reducing systolic and diastolic blood pressure. A meta-analysis revealed significant reductions in blood pressure and improved blood pressure control rates compared to control groups[2].

Pharmacokinetics and Pharmacodynamics

Bisoprolol fumarate has a high bioavailability and a plasma elimination half-life of 9-12 hours. When combined with hydrochlorothiazide, it provides a synergistic effect in managing hypertension. The pharmacodynamic profile of bisoprolol includes a negative chronotropic effect, reducing resting and exercise heart rate, and improving cardiac output[5].

Key Players and Competitive Landscape

Major players in the bisoprolol market are focused on developing innovative formulations and expanding their market presence. Companies like Zydus Lifesciences Limited are at the forefront of these efforts, with recent approvals for generic combinations of bisoprolol and hydrochlorothiazide[1].

Conclusion

The bisoprolol market is poised for significant growth driven by increasing cardiovascular disease prevalence, an aging population, and advancements in drug delivery systems. The integration of artificial intelligence and improvements in cardiovascular diagnostics further support this growth.

Key Takeaways

• The bisoprolol market is expected to grow from $1.84 billion in 2023 to $2.8 billion by 2028.
• Key drivers include the rising prevalence of cardiovascular diseases, an aging population, and improved access to generic medications.
• Innovations in drug delivery systems and patient-centric therapies are significant trends.
• The combination of bisoprolol and hydrochlorothiazide is highly effective in managing hypertension.
• North America is expected to hold the largest market share due to the high concentration of cardiovascular diseases.

FAQs

1. What is the current market size of the bisoprolol market?

The bisoprolol market size was valued at $1.84 billion in 2023 and is projected to reach $2 billion in 2024[1][4].

2. What are the primary applications of bisoprolol?

The primary applications include high blood pressure, coronary heart disease, and angina pectoris[3][4].

3. How effective is the combination of bisoprolol and hydrochlorothiazide in reducing blood pressure?

The combination significantly reduces systolic and diastolic blood pressure, with mean differences of -8.35 mmHg and -7.62 mmHg, respectively, compared to control groups[2].

4. What are the key trends shaping the bisoprolol market?

Key trends include innovations in drug delivery systems, development of patient-centric therapies, integration of artificial intelligence in drug development, and advancements in cardiovascular diagnostics[1][4].

5. Which region is expected to hold the largest market share for bisoprolol?

North America is expected to hold the largest market share due to the high concentration of cardiovascular diseases in this region[3][4].

Cited Sources:

1. Bisoprolol Global Market Report 2024 - GII Research
2. Efficacy and Safety of Low-Dose Bisoprolol/Hydrochlorothiazide - MDPI
3. Bisoprolol Market Size, Share, Trends & Forecast - Verified Market Research
4. Bisoprolol Market Report 2024 - The Business Research Company
5. ZIAC (Bisoprolol Fumarate and Hydrochlorothiazide) Tablets - FDA Label[1][2][3][4][5]