GLYBURIDE; METFORMIN HYDROCHLORIDE - Generic Drug Details

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

Glyburide; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Actavis Elizabeth, Aurobindo Pharma, Heritage, Impax Labs Inc, Teva, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for GLYBURIDE; METFORMIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	27
DailyMed Link:	GLYBURIDE; METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for GLYBURIDE; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Jaeb Center for Health Research	PHASE2
Mannkind Corporation	PHASE2
Middle-Eastern College of Obstetricians and Gynecologists	NA

See all GLYBURIDE; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for GLYBURIDE; METFORMIN HYDROCHLORIDE

Drug Class

Biguanide Sulfonylurea

Anatomical Therapeutic Chemical (ATC) Classes for GLYBURIDE; METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for GLYBURIDE; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076821-003	Jan 27, 2005		DISCN	No	No
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076345-003	Feb 18, 2004	AB	RX	No	No
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870-002	Nov 14, 2007	AB	RX	No	Yes

Expired US Patents for GLYBURIDE; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000	6,303,146*PED
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-002	Jul 31, 2000	6,303,146*PED
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-003	Jul 31, 2000	6,303,146*PED

Market Dynamics and Financial Trajectory for Glyburide and Metformin Hydrochloride

Last updated: February 13, 2026

What is the Current Market Size?

The combined global market for oral antidiabetic medications, including glyburide and metformin hydrochloride, was valued at approximately USD 20 billion in 2022. Growth is expected to reach USD 30 billion by 2030, with a compound annual growth rate (CAGR) of around 4.3% (source: Grand View Research).

Metformin remains the dominant therapy, accounting for around 55% of prescriptions for type 2 diabetes mellitus (T2DM). Glyburide’s market share has declined due to safety concerns and the advent of newer agents, but it retains a significant presence in cost-sensitive markets.

What Are the Key Market Drivers?

• Prevalence of Diabetes: The International Diabetes Federation estimated 537 million adults with diabetes in 2021; this is projected to rise to 643 million by 2030.
• Cost-Effectiveness: Generic formulations of glyburide and metformin are among the most affordable treatments, reinforcing their use in low-to-middle-income regions.
• Regulatory Status: Metformin is classified as essential medicine by WHO, facilitating its widespread availability.
• Patent Expiry: Glyburide’s patent expired in most markets in the late 2000s, leading to a proliferation of generic variants.
• Guideline Incorporation: Both drugs are recommended as first-line therapy, especially metformin, per ADA and EASD guidelines.

How Do Market Trends Affect Revenue Streams?

• Generic Competition: The entry of generics has driven prices down by approximately 50-70% over the past decade (source: IMS Health).
• Emerging Markets: Increased healthcare access and epidemiological shifts have boosted sales volume, compensating for declining per-unit revenue.
• New Formulations & Combinations: Fixed-dose combinations (e.g., metformin with sulfonylureas) are expanding market share and patient adherence.
• Safety Concerns & Shifts: The risk of hypoglycemia and weight gain associated with glyburide leads to declining prescriptions, especially in developed countries.

What Is the Financial Trajectory?

Revenue Trends

• Glyburide: Annual sales peaked at approximately USD 1.5 billion globally in the early 2010s. Current revenues have declined to roughly USD 0.5 billion, primarily in low-income regions.
• Metformin Hydrochloride: Maintains global sales around USD 8-10 billion annually, with steady growth driven by expanding patient populations.

Pricing Dynamics

• Generics Effect: Average wholesale prices (AWP) of metformin 500 mg tablets have decreased from USD 0.10 per tablet in 2015 to USD 0.02 as of 2022.
• Market Penetration: Metformin has over 80% market penetration in some developing economies, e.g., India.

Regulatory & Patent Landscape

• Glyburide’s patents expired in major markets (US, EU) by 2010, reducing revenue. No new patent filings are expected due to its age.
• Extended-release formulations of metformin received FDA approval in 2015, providing premium pricing opportunities but constitute a small percentage of total sales.

What Are the Future Market and Financial Risks?

• Safety and Efficacy Challenges: Concerns over glyburide-associated hypoglycemia hinder future revenue growth.
• Competitive Pressure: The rise of SGLT2 inhibitors and GLP-1 receptor agonists offers alternatives with better safety profiles.
• Market Saturation: Developed markets exhibit slow or negative growth given the mature status of these drugs.
• Pricing Pressure: Increasing adoption of generics and biosimilars continues to push prices downward.

What Is the Outlook for Investment and R&D?

• Companies investing in fixed-dose combination therapies and formulations that improve safety and adherence are positioned for moderate growth.
• For glyburide, the outlook is limited due to safety concerns and market decline.
• Metformin remains core for pipeline development, as derivatives and new formulations explore improved bioavailability and reduced side effects.

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Key Takeaways

• The global market for glyburide and metformin hydrochloride is primarily driven by diabetes prevalence, cost considerations, and guideline recommendations.
• Metformin dominates sales, with continued revenue growth driven by emerging markets and new formulations.
• Glyburide’s market share is declining due to safety issues and generic competition, with limited future revenue potential.
• Pricing reductions due to generics have compressed profit margins, but the drugs' affordability sustains their volume.
• Future growth hinges on development of safer, more effective combination therapies rather than the core monotherapies.

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FAQs

1. Why has glyburide’s market share decreased?
Safety concerns related to hypoglycemia and cardiovascular risks have led physicians to prescribe alternatives like metformin, SGLT2 inhibitors, and GLP-1 receptor agonists.

2. How do price reductions impact profitability?
The introduction of generics has halved prices over recent years, forcing manufacturers to focus on volume growth and novel formulations for revenue stabilization.

3. Are there new formulations of metformin in development?
Yes. Extended-release formulations that improve tolerability have received regulatory approval and include potential for premium pricing.

4. What regions have the highest sales volumes?
Emerging markets such as India, China, and Southeast Asia exhibit high volumes due to large diabetes populations and prevalent use of generics.

5. Will glyburide make a comeback?
Unlikely, due to safety profiles and the availability of better alternatives. Its role remains limited to low-income settings where cost is critical.

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References

[1] Grand View Research. "Oral Antidiabetics Market Size, Share & Trends Analysis." 2022.
[2] International Diabetes Federation. "IDF Diabetes Atlas, 9th Edition." 2021.
[3] IMS Health. "Global Rx Price Trends," 2015-2022.
[4] American Diabetes Association. "Standards of Medical Care in Diabetes," 2022.
[5] World Health Organization. "Model List of Essential Medicines," 2021.