Glyburide - Generic Drug Details

What are the generic drug sources for glyburide and what is the scope of patent protection?

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 Intl, 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. Eighteen 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:	18
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	77
Patent Applications:	7,392
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	PHASE1
Jaeb Center for Health Research	PHASE2
Mannkind Corporation	PHASE2

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
Actavis Elizabeth	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076716-002	Jun 28, 2005	AB	RX	No	No
Aurobindo Pharma	GLYBURIDE	glyburide	TABLET;ORAL	077537-001	Oct 18, 2007		DISCN	No	No
Heritage	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	079009-001	Jun 3, 2009	AB	RX	No	No
Strides Pharma Intl	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074591-003	Dec 22, 1997		DISCN	No	No
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000		DISCN	Yes	No
Epic Pharma Llc	GLYBURIDE	glyburide	TABLET;ORAL	076257-003	Jun 27, 2002	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	020051-001	Mar 4, 1992
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-001	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984

Glyburide Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Glyburide?

Glyburide, a second-generation sulfonylurea, is used for managing type 2 diabetes mellitus. Its market has experienced shifts driven by generic competition and emerging diabetes treatments.

Key Market Drivers

• Prevalence of Type 2 Diabetes: The global diabetes population reached approximately 537 million in 2021, with projections exceeding 700 million by 2045 (IDF Diabetes Atlas, 10th Edition). This sustains demand for oral hypoglycemics like glyburide.
• Generic Availability: Patent expiry in major markets around 2006-2010 enabled a surge in generic glyburide formulations, reducing prices and increasing accessibility.
• Pricing Pressures: Cost reduction strategies by insurers and healthcare providers favor generic agents, further affecting glyburide's market share.
• Alternative Therapies: The advent of newer drugs—DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists—provides competition, especially in patients intolerant to sulfonylureas.
• Regulatory Changes: Evolving guidelines now emphasize safety concerns such as hypoglycemia risk with glyburide, influencing prescribing behavior.

Regional Market Variations

• United States: Glyburide remains a formulary option, especially for cost-sensitive patients. However, its use declines in favor of newer agents.
• Europe: Prescribing shifts towards newer drugs due to safety profiles.
• Emerging Markets: Glyburide maintains a significant role owing to affordability and availability.

Market Size and Trends

• Estimated global glyburide market was valued at approximately USD 250 million in 2022.
• Compound annual growth rate (CAGR) from 2023 to 2028 projected at around 2-3%, primarily driven by emerging markets.
• The US market share is gradually decreasing, with generics competing on price rather than innovation.

What Is the Financial Trajectory for Glyburide?

Despite declines in some regions, glyburide continues generating income primarily via generic sales.

Revenue Trends

Year	Estimated Global Revenue (USD millions)	Key Notes
2020	300	Market stabilizes before annual decline begins.
2021	275	Slight decrease due to emerging-agent preference.
2022	250	Continued decline, especially in developed markets.
2023	230 (projected)	Slow decline persists; emerging markets mitigate fall.

Cost Structure and Profitability

• Manufacturing Costs: Low due to generic manufacturing efficiencies.
• Pricing: Declined by approximately 40% over past decade in major markets.
• Margins: Remain narrow, around 20% gross profit margin margins on average, with net margins often below 10% due to distribution and regulatory costs.

Impact of Patent Expiry and Generics

• Sales volume increased following patent expiry, but price erosion eroded revenue per unit.
• Multiple manufacturers compete, exerting downward price pressure.
• Potential for regulatory restrictions or safety concerns, such as hypoglycemia risks, could further impact sales.

Competitive Landscape

• Key Players: Mylan (Teva), Sun Pharmaceutical, companies in India and China dominate generic glyburide production.
• Emerging Trends: Partnerships and formulations combining glyburide with other agents face limited market impact due to safety concerns and clinical guidelines favoring newer therapies.

What Are the Implications for Investors and R&D?

• Market prospects for glyburide are limited in developed markets but remain relevant in low-income countries.
• Investment in glyburide R&D is unlikely to generate substantial returns given competition and safety issues.
• Opportunities may exist in modifications improving safety profiles or in combination formulations that meet regulatory standards.

Key Takeaways

• Glyburide's global market is declining with a slow, steady trajectory driven by generic competition and safer alternatives.
• Estimated revenues in 2022 approximate USD 250 million, with prospects for further declines.
• Market share varies by region; affordability sustains its relevance in emerging markets.
• Profit margins are narrow, constraining potential reinvestment.
• Future growth hinges on regional economic factors rather than innovation.

FAQs

1. Is glyburide still recommended in clinical guidelines?
Yes, but primarily for resource-limited settings. Guidelines favor newer agents due to safety concerns like hypoglycemia.

2. What are the safety issues associated with glyburide?
Hypoglycemia risk and potential cardiovascular concerns restrict its use, especially in vulnerable populations.

3. How has patent expiry affected glyburide's market?
Patent expiry around 2006-2010 led to a surge in generic availability, lowering prices and expanding access in some markets.

4. Are there ongoing R&D efforts to improve glyburide?
Limited; efforts are more focused on developing new drug classes with better safety profiles.

5. What is the outlook for generic manufacturers?
Continued profitability in emerging markets; price competition remains intense, and regulatory scrutiny may increase safety standards, impacting production.

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References:

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
[2] Market research reports on diabetes medications, 2023.
[3] FDA and EMA drug safety and prescribing guidelines.