GLYBURIDE - Generic Drug Details

What are the generic sources for glyburide and what is the scope of freedom to operate?

Glyburide is the generic ingredient in seven branded drugs marketed by Sanofi Aventis Us, Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Epic Pharma Llc, Heritage, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Natco Pharma, Strides Pharma, Pfizer, and Bristol Myers Squibb, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for glyburide. Twenty suppliers are listed for this compound.

Summary for GLYBURIDE

US Patents:	0
Tradenames:	7
Applicants:	16
NDAs:	27
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	74
Patent Applications:	7,061
Drug Prices:	Drug price trends for GLYBURIDE
Drug Sales Revenues:	Drug sales revenues for GLYBURIDE
What excipients (inactive ingredients) are in GLYBURIDE?	GLYBURIDE excipients list
DailyMed Link:	GLYBURIDE at DailyMed

See drug prices for GLYBURIDE

See drug sales revenues for GLYBURIDE

Recent Clinical Trials for GLYBURIDE

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 2
University of Kentucky	Phase 1
Medical College of Wisconsin	Phase 4

See all GLYBURIDE clinical trials

Pharmacology for GLYBURIDE

Drug Class

Sulfonylurea

Medical Subject Heading (MeSH) Categories for GLYBURIDE

Hypoglycemic Agents

US Patents and Regulatory Information for GLYBURIDE

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	glyburide	TABLET;ORAL	203581-003	Apr 14, 2016		DISCN	No	No
Heritage	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	079009-003	Jun 3, 2009	AB	RX	No	No
Actavis Elizabeth	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076716-003	Jun 28, 2005	AB	RX	No	No
Heritage	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	079009-001	Jun 3, 2009	AB	RX	No	No
Chartwell Rx	GLYBURIDE	glyburide	TABLET;ORAL	203581-002	Apr 14, 2016		DISCN	No	No
Actavis Elizabeth	GLYBURIDE	glyburide	TABLET;ORAL	075947-001	Nov 14, 2002		DISCN	No	No
Heritage	GLYBURIDE	glyburide	TABLET;ORAL	090937-003	Feb 28, 2011	AB1	RX	No	No

Expired US Patents for GLYBURIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	3,507,954
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984	4,060,634
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	3,454,635
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-001	May 1, 1984	3,454,635
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984	3,454,635
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	3,426,067
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	3,507,961

GLYBURIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glyburide

Introduction

Glyburide, a second-generation sulfonylurea, has been a staple in the management of type 2 diabetes for decades. However, its market dynamics and financial trajectory are influenced by a complex array of factors, including regulatory alerts, clinical studies, and market competition.

Market Size and Forecasts

The global glyburide market is analyzed based on both demand and supply sides. Reports indicate that the market size and forecasts are influenced by several key factors:

• Demand Side: The increasing prevalence of type 2 diabetes globally drives the demand for glyburide. However, this demand is also impacted by the availability of alternative treatments and the preference for newer classes of diabetes medications[1][4].
• Supply Side: The supply of glyburide is affected by manufacturing costs, regulatory approvals, and competition from generic versions of the drug.

Regulatory Alerts and Safety Concerns

Recent regulatory alerts have significant implications for the market dynamics of glyburide:

• FDA Warnings: The FDA has issued alerts cautioning against the use of products containing glyburide and metformin that are not prescription-based. These warnings highlight the risks of hypoglycemia and lactic acidosis associated with these drugs, particularly in patients with chronic kidney disease. Such warnings can reduce consumer confidence and impact sales[3].
• Hidden Ingredients: The FDA's warning about hidden ingredients in products like Dr. Ergin’s SugarMD Advanced Glucose Support further complicates the market, as it underscores the need for strict regulation and consumer awareness.

Clinical Studies and Health Risks

Clinical studies have raised concerns about the long-term health risks associated with glyburide:

• Cancer Risk: A study published in Diabetes Care found that longer cumulative durations and higher cumulative doses of glyburide were associated with an increased risk of cancer. This finding could lead to a decline in prescriptions and a shift towards other diabetes medications[5].
• Hypoglycemia and Lactic Acidosis: The risk of hypoglycemia and lactic acidosis, especially when glyburide is combined with other treatments, is a significant concern. These risks can lead to severe health outcomes, including seizures, coma, or death, further impacting the drug's market trajectory[3].

Market Drivers and Barriers

Several factors drive and hinder the glyburide market:

• Market Drivers: The growing prevalence of type 2 diabetes and the need for effective blood glucose management are key drivers. However, the market is also driven by the availability of generic versions of glyburide, which can reduce costs and increase accessibility[4].
• Market Barriers: The emergence of new classes of diabetes medications, such as SGLT2 inhibitors and GLP-1 receptor agonists, poses a significant barrier. These newer drugs often have better safety profiles and additional benefits, such as weight loss and cardiovascular protection, which can attract patients and healthcare providers away from traditional sulfonylureas like glyburide.

Financial Trajectory

The financial performance of companies involved in the production and distribution of glyburide can be impacted by several factors:

• Revenue Trends: The revenue from glyburide sales is likely to decline due to increased competition from newer diabetes medications and the negative impact of regulatory warnings and clinical studies highlighting health risks.
• Cost and Expense Management: Companies may need to manage costs and expenses carefully, including research and development expenses, to maintain profitability. This could involve optimizing operating models and evaluating external opportunities, as seen in the strategies of companies like Biogen[2].

Impact of Generic Versions

The availability of generic versions of glyburide significantly affects the market:

• Price Competition: Generic versions of glyburide can lead to price competition, reducing the revenue for branded versions of the drug.
• Accessibility: Generic glyburide increases accessibility for patients, particularly in regions where cost is a significant factor in healthcare decisions.

Future Outlook

The future outlook for glyburide is complex and multifaceted:

• Regulatory Compliance: Ensuring compliance with regulatory standards and addressing safety concerns will be crucial for maintaining market presence.
• Innovation and Adaptation: Companies may need to innovate or adapt by developing new formulations or combinations that mitigate the risks associated with glyburide.
• Market Shifts: The market is likely to shift towards newer classes of diabetes medications, making it essential for companies to diversify their product portfolios.

Key Takeaways

• Glyburide's market dynamics are influenced by regulatory alerts, clinical studies, and competition from newer diabetes medications.
• The drug's association with increased cancer risk and other health concerns impacts its market trajectory.
• Generic versions of glyburide increase accessibility but reduce revenue for branded versions.
• Companies need to manage costs, innovate, and adapt to maintain profitability in the glyburide market.

FAQs

Q: What are the primary health risks associated with glyburide? A: The primary health risks include an increased risk of cancer, hypoglycemia, and lactic acidosis, especially in patients with chronic kidney disease.

Q: How do FDA warnings impact the market for glyburide? A: FDA warnings about hidden ingredients and the risks associated with glyburide can reduce consumer confidence and impact sales.

Q: What is the impact of generic versions of glyburide on the market? A: Generic versions increase accessibility but lead to price competition, reducing revenue for branded versions.

Q: How do clinical studies affect the market for glyburide? A: Clinical studies highlighting health risks, such as an increased cancer risk, can lead to a decline in prescriptions and a shift towards other diabetes medications.

Q: What strategies can companies adopt to maintain profitability in the glyburide market? A: Companies should focus on regulatory compliance, innovation, cost management, and diversifying their product portfolios to maintain profitability.

Sources

1. The Insight Partners: Glyburide Market Size and Forecasts (2021 - 2031), Global and Regional Analysis.
2. Biogen INC: Form 8-K filed 04/25/2023.
3. FDA: FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support.
4. Cognitive Market Research: Global Glyburide Market Report 2024 Edition, Market Size, Share.
5. AJMC: Diabetes Care Study Finds Increased Cancer Risk With Glyburide.