DIABETA Drug Patent Profile

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

Diabeta is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in DIABETA is glyburide. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the glyburide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diabeta

A generic version of DIABETA was approved as glyburide by TEVA on August 29^th, 1995.

Summary for DIABETA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	6
Patent Applications:	4,287
DailyMed Link:	DIABETA at DailyMed

See drug sales revenues for DIABETA

Recent Clinical Trials for DIABETA

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

Sponsor	Phase
University of Kentucky	Phase 1
Ohio State University	Phase 1/Phase 2
Texas Tech University Health Sciences Center, El Paso	Early Phase 1

See all DIABETA clinical trials

US Patents and Regulatory Information for DIABETA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984	AB2	RX	Yes	No
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984	AB2	RX	Yes	No
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984	AB2	RX	Yes	Yes

Expired US Patents for DIABETA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984

International Patents for DIABETA

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

Country	Patent Number	Title	Estimated Expiration
Finland	275574
Israel	26927	BENZENESULFONYL-UREAS AND PROCESS FOR THEIR MANUFACTURE
Norway	118548

Last updated: July 30, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: DIABETA

Introduction

DIABETA, the generic name for glibenclamide (or glyburide in some regions), is an established oral medication used to manage type 2 diabetes mellitus. Since its introduction in the mid-20th century, DIABETA has played a pivotal role in the anti-diabetic therapeutic landscape, especially in countries with high prevalence rates of diabetes. Understanding its market dynamics and financial trajectory entails analyzing the current demand trends, competitive landscape, regulatory environment, manufacturing economics, and future growth prospects.

Historical Overview and Market Penetration

Since its patent expiration in the late 20th century, DIABETA has experienced widespread generic adoption. Its affordability and efficacy have cemented its position as a frontline therapy in many low- and middle-income countries (LMICs). According to the International Diabetes Federation, global diabetes prevalence has surged to approximately 537 million adults in 2021—projected to rise to 643 million by 2030—driving sustained demand for cost-effective medications like DIABETA[1].

Current Market Dynamics

1. Rising Diabetes Prevalence and Treatment Adoption

The exponential increase in type 2 diabetes cases propels ongoing demand. DIABETA’s low cost and established safety profile make it especially popular in LMICs. The World Health Organization (WHO) estimates that approximately 70% of the global diabetic population resides in these regions, where healthcare infrastructure predominantly favors generic antihyperglycemics[2].

2. Competitive Landscape and Formulation Diversification

While DIABETA remains a staple, the oral antidiabetic market has expanded to include newer drug classes such as SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors. These agents often boast improved efficacy and reduced hypoglycemia risk but at substantially higher costs. As a result, DIABETA retains significant market share due to its affordability and broad acceptance among physicians and patients.

3. Regulatory and Patent Environment

Since DIABETA formulations are off-patent, multiple generic manufacturers operate globally, intensifying market competition. However, variations in quality standards, regulatory approvals, and supply chain logistics influence pricing and market share. Some jurisdictions enforce stringent bioequivalence and manufacturing quality requirements, which can pose barriers to market entry for certain generic manufacturers[3].

4. Pricing Trends and Reimbursement Policies

Pricing for DIABETA remains highly sensitive to government procurement strategies and insurance reimbursements. Governments adopting price caps and centralized procurement benefits from volume discounts, impacting overall revenue. Conversely, in private healthcare markets, pricing remains more flexible, influenced by brand recognition and supplier relations.

5. Supply Chain and Manufacturing Economics

Manufacturing costs for DIABETA are relatively low, primarily due to the drug’s straightforward synthesis and widespread production infrastructure. Nonetheless, recent disruptions attributable to geopolitical tensions, raw material shortages, and regulatory compliance add to supply chain unpredictability, affecting pricing dynamics and availability[4].

Future Financial Trajectory

1. Market Growth Drivers

• Demographic shifts: Continued growth in aging populations and urbanization will expand the diabetic demographic.
• Economic development: Rising healthcare spending in emerging economies will bolster access to affordable treatments like DIABETA.
• Healthcare policy: Governments’ focus on reducing healthcare costs favors the use of generics over newer, expensive agents.

2. Market Challenges

• Shift towards newer drug classes: The emergence of SGLT2 inhibitors and GLP-1 receptor agonists, with proven cardiovascular benefits, may diminish DIABETA’s market share among specific patient subsets.
• Clinical guidelines evolution: Updates in treatment algorithms, emphasizing combination therapies and personalized medicine, could influence initial therapy choices, reducing reliance on monotherapy with drugs like DIABETA.

3. Geographical Expansion and Emerging Markets

Emerging markets are poised to drive future sales, given their high diabetes burdens and cost sensitivity. Companies investing in local manufacturing, regulatory approvals, and distribution networks will benefit from market penetration. For example, India, with over 77 million adults living with diabetes, remains a major growth corridor for DIABETA and similar generics[1].

4. Innovation and Formulation Advances

While patent protections are largely expired, incremental innovations such as fixed-dose combinations and extended-release formulations could enhance adherence and therapeutic outcomes, translating to sustained or increased revenues.

5. Regulatory and Policy Risks

Stringent quality controls and evolving pharmaceutical regulations can restrict supply or increase compliance costs, impacting profitability. Additionally, patent disputes over formulations or manufacturing processes could influence market stability temporarily.

Impact of COVID-19 and Global Health Trends

The COVID-19 pandemic strained healthcare systems worldwide, delaying elective procedures and routine management of chronic diseases. This disruption temporarily suppressed demand but has also heightened awareness of diabetes management, potentially leading to increased screening and diagnosis—long-term drivers for demand in the post-pandemic landscape.

Financial Outlook Summary

In the short-to-medium term, DIABETA’s sales will likely remain stable, bolstered by existing demand and expanding markets in Asia, Africa, and Latin America. Over the next five years, moderate growth is expected, shaped by regional healthcare policies, competitive pressures, and demographic trends. The drug’s low-cost profile and broad acceptance ensure its continued relevance, particularly in regions where affordability is paramount.

Conclusion

DIABETA’s market dynamics are characterized by a mature but steadily growing environment driven by global diabetes prevalence, demographic shifts, and healthcare policy preferences for affordable generics. Although competition from novel agents presents some challenges, the drug’s established position, manufacturing economics, and expanding reach in emerging economies underpin a stable, albeit modest, financial trajectory.

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Key Takeaways

• The global surge in diabetes cases ensures sustained demand for low-cost, generic treatments like DIABETA.
• Competitive pressures from newer drug classes and evolving treatment guidelines may gradually erode market share but are unlikely to eliminate DIABETA’s relevance in cost-sensitive markets.
• Expansion into emerging markets and incremental formulation innovations present future growth avenues.
• Regulatory, supply chain, and policy environments will predominantly influence the drug’s pricing, availability, and profitability.
• Overall, DIABETA maintains a strong position in the antidiabetic market, with a steady financial outlook rooted in ongoing demographic and epidemiological trends.

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FAQs

1. How does DIABETA compare to newer antidiabetic drugs in terms of efficacy and safety?
DIABETA effectively lowers blood glucose levels but has a higher hypoglycemia risk compared to newer agents like SGLT2 inhibitors and GLP-1 receptor agonists. These newer drugs often offer additional cardiovascular and renal benefits, but at increased cost.

2. What are the primary markets driving DIABETA sales today?
Emerging economies—particularly India, China, and African nations—drive most DIABETA sales due to their high diabetes burden and preference for affordable, off-patent medications.

3. How do regulatory processes impact DIABETA’s market presence?
Strict bioequivalence and manufacturing quality requirements in developed markets can complicate approval processes for generics, potentially limiting market entry or leading to supply delays.

4. Will the patent status of DIABETA impair its market until new formulations are developed?
Since DIABETA is off-patent, generic manufacturing proliferates, sustaining low prices and widespread availability. Patents do not materially influence its market presence currently but could impact incremental innovations.

5. What are the key challenges facing DIABETA’s long-term market sustainability?
The shift towards newer therapies with additional benefits, evolving clinical guidelines, and regulatory standards pose challenges. Nevertheless, its affordability and broad acceptance help preserve its market niche.

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Sources:
[1] International Diabetes Federation. IDF Diabetes Atlas, 2021.
[2] World Health Organization. Noncommunicable diseases country profiles, 2018.
[3] U.S. Food and Drug Administration. Generic drug approvals and bioequivalence standards.
[4] IMARC Group. Global Pharmaceutical Market Insights, 2022.