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. Twenty 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:	152
Clinical Trials:	6
Patent Applications:	4,280
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	017532-001	May 1, 1984

International Patents for DIABETA

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

Country	Patent Number	Title	Estimated Expiration
Finland	45959
Netherlands	174222
Cyprus	436	Benzenesulphonyl-ureas and process for their manufacture

DIABETA Market Analysis and Financial Projection Experimental

The Evolving Landscape of the Diabetes Drug Market: Insights and Projections

Introduction to the Diabetes Drug Market

The global diabetes drug market is on a significant growth trajectory, driven by the increasing prevalence of diabetes, particularly type 2 diabetes, which accounts for about 90% of all diabetes cases. Here, we delve into the market dynamics, financial performance, and future projections of this critical sector.

Current Market Size and Growth Projections

As of 2023, the global diabetes drug market was valued at approximately USD 66 billion. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.5% to 7.0% over the next decade, reaching an estimated value of USD 132.36 billion by 2034 or USD 153.98 billion by 2032, depending on the source[1][3][4].

Key Drivers of Market Growth

Rising Prevalence of Type 2 Diabetes

The escalating rates of obesity and significant demographic shifts are major contributors to the surge in type 2 diabetes cases. This trend is particularly pronounced in low- and middle-income countries, where diabetes is becoming a rapidly growing health challenge[1].

Advancements in Diabetes Treatment

The introduction of advanced drugs, such as GLP-1 (Glucagon-Like Peptide-1) medications, has significantly boosted the market. Drugs like Mounjaro and Zepbound from Eli Lilly have shown robust sales growth, with Mounjaro generating $1.8 billion in revenue in Q1 2024, up from $568.5 million in Q1 2023[2].

Increased Drug Adherence and Accessibility

Improvements in drug adherence and the availability of low-priced insulin alternatives have further fueled market growth. The launch of generic versions of several diabetes drugs has made treatment more accessible to a broader patient population[4].

Regional Market Dynamics

North America

North America dominates the diabetes drugs market, valued at USD 39.51 billion in 2023. This region is expected to continue its dominance due to growing investments in research and development, increasing prevalence of diabetes, and favorable reimbursement policies[4].

Europe

Europe is the second-largest market, driven by the rising penetration of key players and the increasing number of diabetes drug launches across the region[4].

Asia Pacific

The Asia Pacific region is expected to grow at the highest CAGR during the forecast period, driven by the growing incidence of diabetes and increasing demand for diabetes care[4].

Middle East & Africa and Latin America

These regions are expected to grow at a moderate to slow pace. The Middle East & Africa will see growth due to the rising patient population suffering from type 2 diabetes, while Latin America faces challenges such as unmet demand for insulin in countries like Brazil and Mexico[4].

Financial Performance of Key Players

Eli Lilly

Eli Lilly has been a standout performer, with its revenue rising 26% to $8.7 billion in Q1 2024, largely driven by its diabetes treatments. The company has raised its full-year revenue guidance by $2 billion, attributing this growth to the success of drugs like Mounjaro and Zepbound[2].

Novo Nordisk

Novo Nordisk, another major player, has seen significant growth in its market capitalization, driven by the success of its GLP-1 drugs, such as semaglutide. The competition between Eli Lilly and Novo Nordisk is expected to continue, with each company aiming to maintain or gain market leadership[2].

Impact of COVID-19 on the Market

The COVID-19 pandemic had a mixed impact on the diabetes drug market. Initial lockdowns reduced patient visits to healthcare settings, but the post-pandemic recovery led to increased hospital visits and a rise in diabetes diagnoses, ultimately propelling the demand for diabetes medications[4].

Patient Out-of-Pocket Costs and Adherence

A significant concern in the diabetes drug market is the out-of-pocket costs for patients. A study found that upon reaching age 65, quarterly out-of-pocket costs for type 2 diabetes drugs increased substantially, which can lead to worse adherence and management of the disease[5].

Research and Development Investments

Growing investments in research and development are crucial for the market's growth. New product launches and the introduction of advanced drugs are anticipated to boost the market during the forecast period. Major players are expanding their production capacities to meet the increasing demand for their medications[2][4].

Market Challenges and Opportunities

Challenges

• High out-of-pocket costs for patients, particularly those transitioning to Medicare.
• Supply shortages due to unprecedented demand for certain drugs.
• Unmet demand for insulin in certain regions.

Opportunities

• Growing prevalence of diabetes, especially in low- and middle-income countries.
• Advancements in diabetes treatment and the introduction of new drugs.
• Increasing focus on generic and low-priced insulin alternatives.

Key Takeaways

• The global diabetes drug market is expected to grow significantly, driven by the rising prevalence of type 2 diabetes and advancements in treatment options.
• Key players like Eli Lilly and Novo Nordisk are driving market growth with their GLP-1 medications.
• Regional dynamics vary, with North America and Europe leading the market, while the Asia Pacific region is expected to grow at the highest CAGR.
• Patient out-of-pocket costs remain a challenge, but growing investments in R&D and the introduction of generic drugs offer opportunities for market expansion.

Frequently Asked Questions

1. What is the current size of the global diabetes drug market?

The global diabetes drug market was valued at approximately USD 66 billion in 2023[1][3][4].

2. What is the projected growth rate of the diabetes drug market?

The market is projected to grow at a CAGR of 6.5% to 7.0% from 2023 to 2032 or 2034, depending on the source[1][3][4].

3. Which regions are expected to dominate the diabetes drug market?

North America and Europe are currently the dominant regions, with the Asia Pacific region expected to grow at the highest CAGR during the forecast period[4].

4. How have COVID-19 and post-pandemic recovery affected the market?

The COVID-19 pandemic initially reduced patient visits, but the post-pandemic recovery led to increased hospital visits and a rise in diabetes diagnoses, propelling the demand for diabetes medications[4].

5. What are the main challenges facing patients in terms of out-of-pocket costs for diabetes medications?

Patients, especially those transitioning to Medicare, face significant increases in out-of-pocket costs, which can lead to worse adherence and management of the disease[5].

Cited Sources:

1. Biospace: "Diabetes Drug Market Size to Attain Around USD 132.36 Billion by 2034"[1]
2. MMM-Online: "Eli Lilly raises financial guidance thanks to robust diabetes sales in Q1"[2]
3. Biospace: "Diabetes Drugs Market Size and Companies (CAGR – 6.7%)"[3]
4. Fortune Business Insights: "Diabetes Drugs Market Share, Growth | Global Report [2032]"[4]
5. JAMA Network: "Patient Out-of-Pocket Costs for Type 2 Diabetes Medications When Transitioning to Medicare"[5]