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Last Updated: December 22, 2024

GLYBURIDE (MICRONIZED) Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Glyburide (micronized)

A generic version of GLYBURIDE (MICRONIZED) was approved as glyburide by TEVA on August 29th, 1995.

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Summary for GLYBURIDE (MICRONIZED)
Drug patent expirations by year for GLYBURIDE (MICRONIZED)
Pharmacology for GLYBURIDE (MICRONIZED)
Drug ClassSulfonylurea

US Patents and Regulatory Information for GLYBURIDE (MICRONIZED)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075174-001 Jun 22, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074686-003 Apr 20, 1999 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074792-002 Jun 26, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890-002 Jul 31, 2003 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

GLYBURIDE (MICRONIZED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glyburide (Micronized)

Introduction to Glyburide (Micronized)

Glyburide, also known as glibenclamide, is a sulfonylurea drug used to treat type 2 diabetes mellitus. It works by stimulating the pancreas to produce more insulin, thereby lowering blood glucose levels. Glyburide is available in micronized form, which has distinct pharmacokinetic properties compared to its non-micronized counterpart[1][4].

Market Drivers

Rising Prevalence of Type 2 Diabetes

The global market for glyburide is driven significantly by the increasing prevalence of type 2 diabetes mellitus. As the population ages and obesity rates rise, the demand for effective diabetes management therapies, including glyburide, is expected to grow[3].

Growing Geriatric and Obese Population

The geriatric and obese populations are more prone to developing type 2 diabetes. This demographic shift is a key driver for the glyburide market, as these groups require ongoing management of their condition, often involving long-term medication[3].

High R&D Investments

Pharmaceutical companies are investing heavily in research and development to create more effective and safer therapies for diabetes management. This includes the development of fixed-dose combinations and combination drugs that include glyburide, which is expected to boost market growth[3].

Market Segmentation

Therapeutic Effect

The glyburide market is segmented based on therapeutic effect, with the primary segment being the treatment of type 2 diabetes mellitus. Other segments include blood sugar management and other related therapeutic uses[3].

Application

The market is also segmented by application, with key segments including pediatric patients and geriatric patients. The geriatric segment is particularly significant due to the higher incidence of type 2 diabetes in this age group[3].

Regional Framework

Global Market Overview

The glyburide market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed market overview[3].

Market Size and Forecast

The global glyburide market is expected to witness significant growth during the forecast period from 2024 to 2031. The market size is projected to increase from US$ XX million in 2023 to US$ XX million by 2031, with a compound annual growth rate (CAGR) of XX%[3].

Financial Trajectory

Historical Analysis

Historical data from 2021 to 2022 shows a steady growth in the glyburide market, driven by increasing demand and advancements in therapeutic applications. This trend is expected to continue into the forecast period[3].

Revenue Forecast

The revenue forecast for the glyburide market indicates strong growth, driven by the rising prevalence of type 2 diabetes and the increasing adoption of combination therapies. The market is expected to reach US$ XX million by 2031, with a significant CAGR[3].

Key Market Players

Several pharmaceutical companies are key players in the glyburide market, focusing on both organic and inorganic growth strategies such as product launches, acquisitions, and partnerships. These companies are expected to continue driving market growth through innovative products and strategic expansions[3].

Challenges and Restraints

Side Effects

Despite its therapeutic benefits, glyburide is associated with several side effects, including heartburn, nausea, and angioedema. These side effects can hinder market growth as patients and healthcare providers seek alternative treatments with fewer adverse effects[3].

Drug Interactions

Glyburide can interact with other medications, such as colesevelam and topiramate, which can reduce its efficacy. These interactions need to be carefully managed to ensure optimal therapeutic outcomes, which can be a challenge in clinical practice[4].

Competitive Landscape

Market Strategies

Companies in the glyburide market are adopting various strategies to maintain and expand their market share. These include product launches, approvals, and partnerships. The competitive landscape is dynamic, with companies continuously innovating to stay ahead[3].

SWOT Analysis

A SWOT analysis of key market players reveals strengths in R&D capabilities and market presence, weaknesses in side effect profiles, opportunities in emerging markets and combination therapies, and threats from regulatory changes and competitor activities[3].

PEST Analysis

Political Factors

Regulatory environments and healthcare policies significantly impact the glyburide market. Changes in regulations or reimbursement policies can affect market dynamics and the financial trajectory of the drug[3].

Economic Factors

Economic conditions, including healthcare spending and insurance coverage, influence the demand for glyburide. Economic downturns can reduce healthcare spending, while economic growth can increase demand for diabetes management therapies[3].

Social Factors

Social factors such as lifestyle changes, dietary habits, and awareness about diabetes management play a crucial role in the market. Increasing awareness and education about diabetes can drive the demand for glyburide[3].

Technological Factors

Advancements in pharmaceutical technology, including the development of new formulations and combination therapies, are driving the market forward. Technological innovations can improve the efficacy and safety of glyburide, enhancing its market position[3].

Key Takeaways

  • The glyburide market is driven by the rising prevalence of type 2 diabetes and growing geriatric and obese populations.
  • High R&D investments and the development of combination therapies are expected to boost market growth.
  • The market is segmented by therapeutic effect and application, with a significant focus on geriatric patients.
  • Regional analysis indicates strong growth potential across North America, Europe, APAC, MEA, and South & Central America.
  • Despite side effects and drug interactions, the market is expected to grow significantly during the forecast period.

FAQs

What is glyburide used for?

Glyburide is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[1].

How does glyburide work?

Glyburide works by stimulating the release of insulin from the pancreas, an effect dependent on functioning beta cells in the pancreatic islets[1].

What are the common side effects of glyburide?

Common side effects of glyburide include heartburn, nausea, and angioedema[3].

Can glyburide be used in combination with other medications?

Yes, glyburide can be used in combination with other medications such as metformin, but it may interact with certain drugs like colesevelam and topiramate, which can affect its efficacy[4].

What is the expected market growth for glyburide?

The glyburide market is expected to grow significantly during the forecast period from 2024 to 2031, driven by the rising prevalence of type 2 diabetes and high R&D investments[3].

Sources

  1. Drugs.com: Glyburide Micronized: Package Insert / Prescribing Info.
  2. Sutter Health: Adult Type 2 Diabetes Guidelines.
  3. The Insight Partners: Glyburide Market Size and Forecasts (2021 - 2031), Global and Regional Analysis.
  4. Pfizer Medical Information: GLYNASE® PRESTAB® (micronized glyburide) Warnings and Precautions.

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