BISOPROLOL FUMARATE - Generic Drug Details

What are the generic sources for bisoprolol fumarate and what is the scope of patent protection?

Bisoprolol fumarate is the generic ingredient in four branded drugs marketed by Alembic, Aurobindo Pharma, Dash Pharms Natco, Harman Finochem, Novitium Pharma, Prinston Inc, Rubicon, Teva Pharms, Trupharma, Unichem, Zydus Lifesciences, Teva Womens, Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Teva, Watson Labs Teva, and Teva Branded Pharm, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for bisoprolol fumarate. Twenty-one suppliers are listed for this compound.

Summary for BISOPROLOL FUMARATE

US Patents:	0
Tradenames:	4
Applicants:	24
NDAs:	26
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	8
Patent Applications:	5,142
Drug Prices:	Drug price trends for BISOPROLOL FUMARATE
What excipients (inactive ingredients) are in BISOPROLOL FUMARATE?	BISOPROLOL FUMARATE excipients list
DailyMed Link:	BISOPROLOL FUMARATE at DailyMed

See drug prices for BISOPROLOL FUMARATE

Recent Clinical Trials for BISOPROLOL FUMARATE

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

Sponsor	Phase
Alexandria University	Phase 2
Damanhour University	Phase 2
Laval University	N/A

See all BISOPROLOL FUMARATE clinical trials

Pharmacology for BISOPROLOL FUMARATE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for BISOPROLOL FUMARATE

Adrenergic beta-1 Receptor Antagonists

Antihypertensive Agents

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for BISOPROLOL FUMARATE

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

US Patents and Regulatory Information for BISOPROLOL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	075644-001	Jun 26, 2001		DISCN	No	No
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-001	Mar 26, 1993	AB	RX	Yes	No
Rubicon	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	075643-002	Nov 16, 2000	AB	RX	No	No
Aurobindo Pharma	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	077910-002	Dec 27, 2006	AB	RX	No	No
Zydus Lifesciences	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	215680-001	Jul 25, 2022	AB	RX	No	No
Rubicon	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	075643-001	Nov 16, 2000	AB	RX	No	No

Expired US Patents for BISOPROLOL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-002	Jul 31, 1992
Teva Womens	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-001	Jul 31, 1992

BISOPROLOL FUMARATE Market Analysis and Financial Projection Experimental

Bisoprolol Fumarate Market Dynamics and Financial Trajectory

Introduction to Bisoprolol Fumarate

Bisoprolol fumarate is a beta-blocker primarily used to treat hypertension (high blood pressure) and heart failure. As a selective beta-1 adrenergic antagonist, it reduces heart rate and the workload on the heart, leading to lower blood pressure and improved heart function[1][5].

Market Growth Drivers

The bisoprolol fumarate market is experiencing significant growth driven by several key factors:

Rising Prevalence of Cardiovascular Diseases

The global increase in cardiovascular diseases such as hypertension, heart failure, and coronary heart disease is a major driver. As populations age and lifestyle-related diseases become more prevalent, the demand for effective cardiovascular treatments like bisoprolol fumarate is on the rise[1][4].

Expanding Generic Market

The expiration of patents for bisoprolol fumarate has led to the entry of generic versions, making the drug more affordable and accessible to patients in developing and low-income countries. This has significantly boosted market growth[1].

Advancements in Drug Formulations

Innovations in drug delivery systems, such as long-acting formulations and once-daily dosing, have improved patient compliance and therapeutic efficacy. Additionally, the development of liquid formulations for patients with swallowing difficulties further expands the market[1].

Combination Therapies

The trend towards combination therapies, where bisoprolol is prescribed alongside other cardiovascular drugs like ACE inhibitors and diuretics, has enhanced therapeutic benefits and contributed to market growth[1].

Market Size and Projections

The bisoprolol fumarate market is projected to see substantial growth in the coming years:

Current Market Size

The market size was approximately $1.84 billion in 2023 and is expected to grow to $2 billion in 2024, with a compound annual growth rate (CAGR) of 8.6%[4].

Future Projections

By 2028, the market is forecasted to reach $2.8 billion, maintaining a CAGR of 8.7%. This growth is attributed to factors such as the expansion of cardiovascular specialty clinics, enhanced patient support programs, and increased funding for cardiovascular health initiatives[4].

Segmentation of the Market

The bisoprolol fumarate market can be 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 higher bioavailability[4].

By Distribution Channels

The drug is distributed through hospital pharmacies, retail pharmacies, and other distribution channels. Hospital pharmacies play a significant role due to the frequent need for cardiovascular medications in hospital settings[4].

By Application

Bisoprolol fumarate is used primarily for high blood pressure, coronary heart disease, angina pectoris, and other cardiovascular applications. High blood pressure remains the most significant application area[4].

Regional Analysis

The market is split across various regions, with significant growth observed in:

Emerging Markets

Asia-Pacific, Latin America, and parts of Africa are seeing increased adoption due to the drug's effectiveness, cost-efficiency, and accessibility. Government healthcare reforms in these regions are also driving the market by ensuring the widespread availability of heart disease treatments[1].

Developed Markets

In regions like Europe and North America, the market is driven by advanced healthcare systems, higher awareness of hypertension management, and increased healthcare expenditure[4].

Economic Impact and Cost Savings

Bisoprolol fumarate not only provides health benefits but also offers significant cost savings:

Reduced Hospital Admissions

Studies such as the Cardiac Insufficiency Bisoprolol Study (CIBIS II) have shown that bisoprolol therapy reduces hospital admissions, days spent in hospital, and costs associated with hospital care. This results in a 5-10% reduction in healthcare costs even after accounting for the cost of the drug and additional medical visits[2].

Long-Term Cost Benefits

The long-term use of bisoprolol fumarate in managing chronic heart failure leads to sustained cost savings for healthcare systems and patients. This is due to reduced need for hospitalizations and other costly medical interventions[2].

Investment Opportunities and Business Potential

The bisoprolol fumarate market presents several investment opportunities:

Research and Development

Investments in R&D focused on improving drug formulations and expanding distribution networks in emerging markets are expected to drive growth. Innovations in drug delivery systems and patient-centric therapies are particularly promising areas[1].

Strategic Partnerships

Pharmaceutical companies are entering into strategic partnerships with healthcare providers, NGOs, and governments to enhance the availability and affordability of bisoprolol fumarate. These partnerships facilitate the development of new formulations and ensure economies of scale[1].

Challenges and Future Directions

While the market is poised for growth, there are some challenges to consider:

Regulatory Environment

Changes in regulatory policies and healthcare reforms can impact the market. However, current trends suggest that governments are supportive of making cardiovascular treatments more accessible[1].

Competition from New Therapies

The emergence of new cardiovascular therapies could potentially challenge the dominance of bisoprolol fumarate. However, its established efficacy and cost-effectiveness make it a strong contender in the market[4].

Key Takeaways

• The bisoprolol fumarate market is driven by the global demand for effective cardiovascular treatments.
• Generic versions and advancements in drug formulations are key growth drivers.
• The market is expected to grow significantly, reaching $2.8 billion by 2028.
• Emerging markets and strategic partnerships are crucial for future growth.
• Bisoprolol fumarate offers significant cost savings in healthcare by reducing hospital admissions and long-term care costs.

Frequently Asked Questions

Q: What is the primary use of bisoprolol fumarate? A: Bisoprolol fumarate is primarily used to treat high blood pressure (hypertension) and heart failure.

Q: How does bisoprolol fumarate work? A: Bisoprolol fumarate works by blocking certain receptors in the heart, leading to a reduction in heart rate and the workload on the heart, resulting in lower blood pressure and improved heart function.

Q: What are the key drivers of the bisoprolol fumarate market? A: The key drivers include the rising prevalence of cardiovascular diseases, the expansion of generic markets, advancements in drug formulations, and the trend towards combination therapies.

Q: What are the projected market sizes for bisoprolol fumarate? A: The market size is expected to grow from $1.84 billion in 2023 to $2 billion in 2024 and reach $2.8 billion by 2028.

Q: How does bisoprolol fumarate impact healthcare costs? A: Bisoprolol fumarate reduces healthcare costs by decreasing hospital admissions, days spent in hospital, and associated care costs, leading to a 5-10% reduction in overall healthcare expenditure.

Sources

1. Market Research Intellect: "The Future of Cardiovascular Treatment: Bisoprolol Fumarate Market Shows Strong Growth"
2. PubMed: "Reduced costs with bisoprolol treatment for heart failure"
3. Market Research Intellect: "Global Bisoprolol Fumarate Market Size, Trends and Projections"
4. The Business Research Company: "Bisoprolol Market Report 2024 - Growth And Trends Analysis"
5. FDA: "Zebeta (Bisoprolol Fumarate) Tablets"