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. Eighteen 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:	4,023
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	017532-003	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

International Patents for DIABETA

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

Country	Patent Number	Title	Estimated Expiration
Austria	261627
Austria	262308
Austria	262309

Market Dynamics and Financial Trajectory for DIABETA

Last updated: March 18, 2026

What is DIABETA and its current market positioning?

DIABETA contains the active ingredient gliclazide, a second-generation sulfonylurea used to treat type 2 diabetes mellitus. It is marketed globally but has varying approval statuses. In many regions, it is a preferred medication due to its effectiveness and safety profile compared to earlier sulfonylureas.

Market penetration remains strong in Asia, Latin America, and Europe, where it competes with other sulfonylureas and newer drug classes such as DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors.

How has DIABETA’s market size evolved globally?

Recent estimates suggest the global market for gliclazide-containing drugs approaches USD 230 million in 2023, with a compound annual growth rate (CAGR) of approximately 4–6% over the past five years. The growth is driven by increasing prevalence of type 2 diabetes, particularly in emerging markets.

Region	Market Size (USD millions)	CAGR (2018–2023)	Key Drivers
Asia-Pacific	90	6%	Rising diabetes prevalence, expanding healthcare access
Europe	70	3%	Aging population, established healthcare systems
Latin America	45	5%	Growing middle class, urbanization
North America	25	2%	Market share limited due to preference for newer drugs

What are key factors influencing DIABETA’s financial trajectory?

Market Expansions

• Emerging Markets: Countries such as India, China, and Brazil exhibit rapid growth in diabetes cases. Governments increasingly endorse affordable oral hypoglycemics like DIABETA.
• Regulatory Approvals: Some regions have extended or renewed approval for gliclazide, supporting steady sales.

Competitive Landscape

• Generic Entry: Patent expirations have led to generics, decreasing prices and margins but expanding volume.
• Newer Drugs: DPP-4, GLP-1, and SGLT2 classes have gained market share due to perceived benefits, pressuring gliclazide sales.

Clinical and Safety Profile Advantages

• Lower hypoglycemia risk compared to older sulfonylureas has improved its positioning.
• Growing evidence from clinical trials supports its safety and efficacy, favoring sustained demand.

Formulation and Delivery Trends

• Availability in immediate-release and modified-release formulations influences prescribing patterns.
• Fixed-dose combinations with other antidiabetics expand market opportunities.

How does pricing impact DIABETA's financial outlook?

Generic competition has driven prices down by approximately 20–30% over the past three years in mature markets. In emerging markets, pricing remains more stable, supported by healthcare subsidies and government procurement programs.

According to industry reports, wholesale prices for DIABETA range from USD 0.10 to USD 0.50 per tablet, depending on manufacturing costs and regional factors. Volume sales are expected to compensate for lower margins, especially in high-growth regions.

What are future growth prospects and risks?

Growth Drivers

• Rising diabetes prevalence (~463 million globally) fosters sustained demand.
• Adoption of affordable therapies in resource-limited settings sustains revenue.
• R&D efforts focus on combination therapies and improved formulations.

Risks

• Shift to newer drug classes with better safety profiles.
• Pricing pressures from increased generic competition.
• Regulatory hurdles impeding market expansion.

How are pharma companies approaching DIABETA’s market?

Lupin, Sanofi, and other generics producers dominate production. Some originator companies are phasing out direct marketing, focusing instead on licensing and contract manufacturing.

In licensing agreements, companies bundle DIABETA with other generics or co-formulated products to secure market share.

Summary of key financial indicators

Parameter	2023 Estimate	Notes
Global sales	USD 230 million	Steady growth in emerging markets
Market share (generics)	Over 80% in key markets	Prices decline due to competition
Price per tablet	USD 0.10 – 0.50	Varies regionally
Main revenue region	Asia-Pacific (39%)	Largest contributor

Final considerations

Sustained market presence depends on leveraging generic manufacturing efficiencies, expanding into new regions, and developing combination formulations. Monitoring regulatory landscapes and competitors' product launches will be critical.

Key Takeaways

• The global market for DIABETA approximates USD 230 million in 2023, growing at around 5% annually.
• Growth is driven by rising diabetes prevalence, especially in emerging markets.
• Price erosion due to generic competition remains a significant factor, balanced by volume increases.
• Market expansion depends on regional regulatory approvals and formulation innovations.
• Competition from newer drug classes introduces a long-term threat to gliclazide’s market share.

FAQs

1. How will entry of SGLT2 inhibitors affect DIABETA sales?
SGLT2 inhibitors offer better safety and cardiovascular benefits, leading to a shift away from sulfonylureas in some markets, potentially reducing DIABETA's growth rate.

2. Are there any patent protections remaining for original gliclazide formulations?
Most patents have expired globally; thus, generic versions dominate markets, lowering prices and margins.

3. What regulatory hurdles could impact further market expansion?
Regulatory agencies may require new safety data, delayed approvals, or restrictions on use, especially in markets emphasizing cardiovascular safety.

4. Which markets are fastest-growing for DIABETA?
India, China, and Brazil lead growth, driven by increasing diabetes cases and demand for affordable treatments.

5. How does clinical evidence influence DIABETA's market share?
Strong evidence of safety and efficacy supports continued use; however, emerging data favoring newer drugs can diminish its prescribing frequency.

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References

[1] World Health Organization. (2021). Diabetes Fact Sheet.
[2] IQVIA. (2023). Global Pharmaceutical Market Trends.
[3] ClinicalTrials.gov. (2022). Gliclazide Safety and Efficacy Trials.
[4] Pharma Economics. (2022). Impact of Patent Expirations on Sulfonylureas.
[5] IMS Health. (2023). Regional Diabetes Treatment Market Analysis.