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Last Updated: April 21, 2025

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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When do Bisoprolol Fumarate And Hydrochlorothiazide patents expire, and what generic alternatives are available?

Bisoprolol Fumarate And Hydrochlorothiazide is a drug 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, and Watson Labs Teva. and is included in thirteen NDAs.

The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bisoprolol Fumarate And Hydrochlorothiazide

A generic version of BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE was approved as bisoprolol fumarate; hydrochlorothiazide by EPIC PHARMA LLC on September 25th, 2000.

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Summary for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
US Patents:0
Applicants:13
NDAs:13
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 9
What excipients (inactive ingredients) are in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE?BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE at DailyMed
Drug patent expirations by year for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Pharmacology for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

US Patents and Regulatory Information for BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Epic Pharma Llc BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075579-003 Sep 25, 2000 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ivax Sub Teva Pharms BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075632-003 Sep 27, 2000 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actavis Elizabeth BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075672-001 Sep 25, 2000 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075686-002 Jan 19, 2001 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075686-003 Jan 19, 2001 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novitium Pharma BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 215562-001 Nov 4, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novitium Pharma BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 215562-002 Nov 4, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

Bisoprolol Fumarate and Hydrochlorothiazide: Market Dynamics and Financial Trajectory

Introduction

Bisoprolol fumarate and hydrochlorothiazide, a combination of a beta-blocker and a diuretic, is a widely used medication for the treatment of hypertension and other cardiovascular conditions. This article delves into the market dynamics and financial trajectory of this drug, highlighting key drivers, trends, and future projections.

Market Size and Growth

The global bisoprolol market, which includes bisoprolol fumarate and hydrochlorothiazide combinations, has experienced significant growth in recent years. In 2023, the market size was valued at $1.84 billion and is expected to grow to $2 billion in 2024, with a compound annual growth rate (CAGR) of 8.6%[1][3][4].

By 2028, the market is projected to reach $2.8 billion, maintaining a CAGR of 8.7%. This robust growth is driven by several factors, including the increasing prevalence of cardiovascular diseases, an aging population, improved access to generic medications, and heightened awareness of hypertension management.

Key Drivers of the Market

Rising Prevalence of Hypertension

Hypertension, characterized by consistently elevated blood pressure levels, is a major driver of the bisoprolol market. Factors such as sedentary lifestyles, high rates of obesity, and poor diets contribute to the rising cases of hypertension. For instance, according to the Center for Disease Control and Prevention, nearly half of adults in the US have hypertension, with only about 24% having their condition under control[4].

Aging Population and Lifestyle-Related Diseases

The growing aging population and the increase in lifestyle-related diseases also contribute to the demand for bisoprolol. As people age, the risk of developing cardiovascular diseases increases, leading to a higher demand for antihypertensive medications like bisoprolol fumarate and hydrochlorothiazide.

Expanding Availability of Generic Drugs

The availability of generic combinations of bisoprolol fumarate and hydrochlorothiazide has significantly impacted the market. Companies like Zydus Lifesciences Limited and Glenmark have received FDA approvals for their generic versions of these medications, making them more accessible and affordable for patients[1][3][4].

Market Segmentation

By Type

The bisoprolol market is segmented by type into tablets and capsules. The tablet form is particularly popular due to its ease of administration and the availability of extended-release formulations, which enhance patient adherence and long-term hypertension control[1][3][4].

By Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and other distribution channels. Retail pharmacies are a significant segment due to their widespread presence and convenience for patients[1][3].

By Application

Bisoprolol fumarate and hydrochlorothiazide are used for various applications, including high blood pressure, coronary heart disease, angina pectoris, and other cardiovascular conditions. High blood pressure is the most dominant application, driven by the high prevalence of hypertension globally[1][3][4].

Trends and Strategies

Innovations in Drug Delivery Systems

One of the key trends in the bisoprolol market is the advancement in drug delivery systems. Extended-release tablets, such as those approved by the FDA for Zydus Lifesciences Limited and Glenmark, ensure steady medication levels throughout the day, improving patient adherence and efficacy[1][3][4].

Patient-Centric Therapies

The development of patient-centric therapies is another significant trend. These therapies are designed to meet the specific needs of patients, enhancing their overall treatment experience and outcomes.

Integration of Artificial Intelligence

The integration of artificial intelligence in drug development is also a notable trend. AI can help in identifying new drug targets, optimizing clinical trials, and personalizing treatment plans, which can further boost the market growth[1][3].

Regional Analysis

The bisoprolol market is analyzed across various regions, including North America, Europe, Asia-Pacific, and the rest of the world. North America and Europe are significant markets due to the high prevalence of hypertension and well-established healthcare systems. However, the Asia-Pacific region is expected to show the fastest growth due to the large population and increasing awareness of cardiovascular health[1][3][4].

Competitive Landscape

The bisoprolol market is competitive, with major players such as Novartis International AG, Merck & Co., Inc., and Teva Pharmaceutical Industries Ltd. These companies are adopting various strategies, including mergers and acquisitions, geographical expansion, partnerships, and new product launches, to maintain their market share and drive growth[4].

Financial Projections

Historic Market Size and Growth

The bisoprolol market has seen strong growth in the historic period from 2018 to 2023, driven by the factors mentioned above. The market size increased from $1.34 billion in 2018 to $1.84 billion in 2023[1][3].

Forecast Market Size and Growth

For the forecast period from 2023 to 2028, the market is expected to grow to $2.8 billion, with a CAGR of 8.7%. This growth will be driven by the expansion of cardiovascular specialty clinics, enhanced patient support programs, and increased funding for cardiovascular health initiatives[1][3].

Impact of Macro Economic Factors

High Inflation

High inflation can impact the bisoprolol market by increasing the costs of raw materials and manufacturing, potentially leading to higher drug prices. However, the demand for essential medications like bisoprolol is less elastic, so the impact may be minimal[1].

Ukraine-Russia War

The Ukraine-Russia war can affect the global supply chain, including the pharmaceutical industry. However, the bisoprolol market is diversified, and major players have multiple manufacturing sites, which can mitigate the impact[1].

COVID-19

The COVID-19 pandemic has accelerated the adoption of telehealth services and remote patient monitoring, which can enhance the management of hypertension and other cardiovascular conditions. This has positively impacted the bisoprolol market by increasing the demand for antihypertensive medications[1][3].

Pharmacokinetics and Pharmacodynamics

Bisoprolol fumarate and hydrochlorothiazide have distinct pharmacokinetic and pharmacodynamic profiles. Bisoprolol fumarate has an absolute bioavailability of about 80% and a plasma elimination half-life of 9-12 hours. It reduces heart rate and blood pressure by its negative chronotropic effect. Hydrochlorothiazide, a diuretic, reduces fluid retention and has a plasma elimination half-life of 6-15 hours. The combination of these two drugs provides additive effects in reducing systolic and diastolic blood pressure[2].

Clinical Studies and Efficacy

Clinical studies have shown that the combination of bisoprolol fumarate and hydrochlorothiazide is effective in reducing blood pressure across various age groups and racial demographics. The treatment effects are consistent, and the combination is more effective than either component used alone[2].

Key Takeaways

  • The bisoprolol market is expected to grow significantly, driven by the increasing prevalence of hypertension and other cardiovascular diseases.
  • The availability of generic combinations and advancements in drug delivery systems are key drivers of market growth.
  • Major players are focusing on innovative formulations and patient-centric therapies to expand their market share.
  • The integration of artificial intelligence and progress in cardiovascular diagnostics are trends that will shape the future of the bisoprolol market.

FAQs

What is the current market size of the bisoprolol market?

The bisoprolol market size was valued at $1.84 billion in 2023 and is expected to grow to $2 billion in 2024[1][3].

What are the key drivers of the bisoprolol market?

The key drivers include the rising prevalence of hypertension, an aging population, improved access to generic medications, and heightened awareness of hypertension management[1][3][4].

Which regions are expected to show the fastest growth in the bisoprolol market?

The Asia-Pacific region is expected to show the fastest growth due to the large population and increasing awareness of cardiovascular health[1][3][4].

What are the major trends in the bisoprolol market?

Major trends include innovations in drug delivery systems, the development of patient-centric therapies, the integration of artificial intelligence in drug development, and progress in cardiovascular diagnostics[1][3].

Who are the major players in the bisoprolol market?

Major players include Novartis International AG, Merck & Co., Inc., and Teva Pharmaceutical Industries Ltd.[4].

Sources

  1. The Business Research Company - Bisoprolol Market Report 2024 - Growth And Trends Analysis
  2. FDA - ZIAC (Bisoprolol Fumarate and Hydrochlorothiazide) Tablets
  3. GII Research - Bisoprolol Global Market Report 2024
  4. OMR Global - Bisoprolol Market - Global Industry Reports and Forecast to 2028

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