GLUCOVANCE Drug Patent Profile

Which patents cover Glucovance, and when can generic versions of Glucovance launch?

Glucovance is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in GLUCOVANCE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glucovance

A generic version of GLUCOVANCE was approved as glyburide; metformin hydrochloride by IMPAX LABS INC on February 18^th, 2004.

Summary for GLUCOVANCE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	7
Patent Applications:	418
Drug Prices:	Drug price information for GLUCOVANCE
What excipients (inactive ingredients) are in GLUCOVANCE?	GLUCOVANCE excipients list
DailyMed Link:	GLUCOVANCE at DailyMed

See drug prices for GLUCOVANCE

Recent Clinical Trials for GLUCOVANCE

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

Sponsor	Phase
Texas Tech University Health Sciences Center, El Paso	Early Phase 1
Ortho Biotech Products, L.P.	Phase 4
Brigham and Women's Hospital	Phase 4

See all GLUCOVANCE clinical trials

US Patents and Regulatory Information for GLUCOVANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000		DISCN	Yes	No
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-002	Jul 31, 2000		DISCN	Yes	No
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-003	Jul 31, 2000		DISCN	Yes	No

Expired US Patents for GLUCOVANCE

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	021178-003	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

International Patents for GLUCOVANCE

See the table below for patents covering GLUCOVANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	5417999
European Patent Office	2269613
Portugal	974356
Argentina	013052	UNA FORMA DE DOSIS ORAL SOLIDA QUE COMPRENDE UNA COMBINACION DE METFORMIN Y GLIBENCLAMIDA
Japan	2003292443	PERORAL ADMINISTRATION SOLID PREPARATION COMPRISING COMBINATION OF METFORMIN AND GLIBENCLAMIDE
Canada	2303537	FORME POSOLOGIQUE ORALE SOLIDE COMPRENANT UNE COMBINAISON DEMETFORMINE ET DE GLIBENCLAMIDE (SOLID ORAL DOSAGE FORM COMPRISING A COMBINATION OF METFORMINAND GLIBENCLAMIDE)

Market Dynamics and Financial Trajectory for Glucovance

Last updated: July 31, 2025

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Introduction

Glucovance, a combination drug comprising metformin and glyburide, plays a pivotal role in managing type 2 diabetes mellitus. Approved by the FDA in the early 2000s, Glucovance offers an alternative to monotherapy, providing synergistic control of blood glucose levels. As the global burden of diabetes escalates, understanding the market dynamics and financial trajectory of Glucovance becomes critical for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Overview

Global Diabetes Landscape

The International Diabetes Federation (IDF) estimates approximately 537 million adults globally live with diabetes as of 2021, projected to reach 643 million by 2030. Type 2 diabetes accounts for over 90% of cases, demanding extensive pharmacotherapy options. Glucovance, positioned in the oral combination therapy sector, targets a significant segment of this burgeoning market.

Therapeutic Position of Glucovance

Glucovance offers a convenient fixed-dose combination (FDC), simplifying medication regimens for patients struggling with adherence. Its dual-action methodology combines the insulin-sensitizing effects of metformin with the insulin-secretagogue activity of glyburide. However, the advent of newer agents, such as SGLT2 inhibitors and GLP-1 receptor agonists, with proven cardiovascular benefits, has challenged Glucovance’s dominance.

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Market Drivers

• Increasing Prevalence of Type 2 Diabetes: Rapid urbanization, sedentary lifestyles, and poor dietary habits are fueling this growth.
• Cost-Effective Treatment Option: As a generic combination, Glucovance presents an affordable therapy option, especially in emerging markets.
• Patient Adherence: Fixed-dose formulations enhance compliance by reducing pill burden.
• Physician Prescribing Habits: Despite the rise of newer drugs, fixed-dose combinations of established agents remain a preferred initial therapy due to familiarity and safety profiles.

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Market Challenges

• Availability of Newer Therapeutics: SGLT2 inhibitors (e.g., Jardiance) and GLP-1 receptor agonists outperform Glucovance concerning cardiovascular and renal outcomes.
• Safety Concerns: Glyburide's association with hypoglycemia and weight gain limits its appeal.
• Regulatory Environment: Evolving guidelines increasingly favor newer agents, potentially restricting the growth of older combinations like Glucovance.
• Patent and Market Exclusivity: As a generic drug, Glucovance is subject to pricing pressures and narrow profit margins, especially in competitive markets.

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Financial Trajectory

Historical Revenue Trends

Original patent exclusivity granted Glucovance pharmacoeconomic advantages during the early 2000s. Post-genericization, revenue trajectories declined significantly, with sales mainly sustained through established patient populations and limited promotional efforts.

Current Market Performance

Most pharmaceutical incumbents report declining sales of Glucovance, attributed to:

• Market saturation in developed economies.
• Patent expirations and widespread generic availability.
• Transition of prescribers towards newer agents with additional benefits.

Forecasting Future Revenue

Based on industry reports, the revenue for Glucovance is expected to decline at a compounded annual rate (CAR) of roughly 5-8% over the next five years (2023-2028), driven by:

• Further market share erosion.
• Increased adoption of newer, branded therapies.
• Growing emphasis on individualized patient-centered treatment paradigms favoring newer drug classes.

However, in emerging markets where affordability remains key, Glucovance could sustain modest demand, offering stability in certain regions.

Revenue Diversification via Patent Strategies

Pharmaceutical firms may employ patent extensions or develop new formulations (e.g., sustained-release variants) to delay generic competition, potentially providing temporary revenue infusions.

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Strategic Outlook

Potential Opportunities

• Combination with Novel Agents: Incorporating Glucovance into combination regimens with SGLT2 inhibitors or GLP-1 receptor agonists could potentially recover market interest, provided safety and efficacy are demonstrated.
• Therapeutic Switching: As patients switch from newer agents due to cost or tolerability issues, Glucovance may regain relevance in cost-sensitive settings.
• Emerging Market Penetration: The low-cost profile aligns well with healthcare infrastructure in Asia, Africa, and Latin America.

Risks and Mitigation Strategies

• Competitive Displacement: Firms should innovate through novel formulations or delivery mechanisms.
• Regulatory Changes: Proactive engagement with health authorities ensures compliance with evolving guidelines.
• Market Education: Continuous education on the benefits of combination therapy can sustain prescriber interest.

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Regulatory and Patent Considerations

Glucovance’s original patent protection has long expired, leaving it open to generic manufacturing. While this reduces costs, it also compels companies to explore secondary patents or novel formulations to extend exclusivity periods.

Impact of Evolving Treatment Guidelines

Recent guidelines by American Diabetes Association and European Association for the Study of Diabetes favor SGLT2 inhibitors and GLP-1 receptor agonists for patients with cardiovascular comorbidities. This regulatory shift diminishes the role of traditional agents like glyburide and, by extension, Glucovance.

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Key Market Segments and Geographies

• Developed Markets: Declining sales expected due to preference for newer agents.
• Emerging Markets: Stable or increasing demand driven by affordability and disease burden.
• Private vs. Public Healthcare Sectors: Public healthcare systems favor low-cost generics, sustaining demand in resource-limited settings.

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Conclusion

The market dynamics of Glucovance reflect a typical lifecycle of a legacy drug facing obsolescence amid innovation. While its financial trajectory is downward in mature markets, strategic adaptations—such as new formulations, integration into combination regimens, and focus on emerging economies—may provide avenues to sustain revenue streams temporarily. Nonetheless, long-term growth prospects hinge on addressing evolving clinical guidelines, safety perceptions, and competitor innovation.

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Key Takeaways

• Market Decline: Glucovance’s sales are waning in developed markets, largely due to competition from newer, more efficacious agents with added benefits.
• Cost Advantage: Its affordability remains advantageous in low-resource settings, maintaining steady demand in emerging markets.
• Innovation Needs: Opportunities exist through formulation improvements or combination therapies incorporating Glucovance.
• Regulatory Shifts: Evolving guidelines increasingly favor full-ingredient replacement with newer drug classes, threatening traditional combination therapies.
• Strategic Focus: Companies should leverage geographic diversification, patent strategies, and educational initiatives to sustain market relevance.

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FAQs

1. Is Glucovance still a viable treatment option for type 2 diabetes?
While still prescribed in certain markets, Glucovance’s role is diminishing in favor of newer agents with proven cardiovascular and renal benefits. Its viability depends on regional formulary preferences, patient affordability, and ongoing clinical needs.

2. How does the patent status of Glucovance affect its market?
With the original patent expired, Glucovance is available as a generic, leading to price competition and reduced profit margins. Patent expirations limit exclusivity, emphasizing the importance of strategic formulation updates.

3. Are there ongoing developments to improve Glucovance?
Some manufacturers explore sustained-release formulations or fixed-dose combinations with novel agents. However, widespread development is limited due to shifting clinical guidelines favoring newer drug classes.

4. What are the main factors influencing the decline of Glucovance’s revenues?
Key factors include the availability of newer, more effective drugs; safety concerns associated with glyburide; evolving treatment guidelines; patent expirations; and market saturation in mature economies.

5. Can Glucovance regain market share in the future?
Potentially, in low-income or resource-constrained settings where affordability is paramount, or if strategic re-positioning occurs through combination innovations. Otherwise, its long-term relevance remains constrained by the clinical landscape’s evolution.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2021.
[2] American Diabetes Association. Standards of Medical Care in Diabetes—2022.
[3] Market research reports on oral combination therapies in diabetes.
[4] FDA approvals and pharmacovigilance data on Glucovance and related agents.