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. Twelve 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:	6
Clinical Trials:	7
Patent Applications:	23
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
Brigham and Women's Hospital	Phase 4
Ortho Biotech Products, L.P.	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
Germany	69818444
Austria	250418
European Patent Office	1435240
China	1486698
Uruguay	25611	FORMAS SOLIDAS DE DOSIFICACION ORAL PARA EL TRATAMIENTO DE DIABETES NO DEPENDIENTE DE INSULINA
Indonesia	25784
European Patent Office	0974356	Comprimés contenant une combinaison de glibenclamide et de metformine (Tablets comprising a combination of metformin and glibenclamide)

GLUCOVANCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GLUCOVANCE

Introduction to GLUCOVANCE

GLUCOVANCE is a combination drug that includes glyburide and metformin hydrochloride, two antihyperglycemic agents designed to improve glycemic control in adults with type 2 diabetes mellitus. This medication is indicated as an adjunct to diet and exercise[1][4].

Mechanism of Action and Clinical Benefits

GLUCOVANCE works by combining the mechanisms of glyburide, which stimulates insulin release from the pancreas, and metformin, which decreases hepatic glucose production and increases insulin sensitivity. This dual action results in significant reductions in HbA1c, fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) compared to using either drug alone or placebo[1].

Market Position and Demand

The demand for GLUCOVANCE is driven by the growing prevalence of type 2 diabetes globally. As the population ages and lifestyles become more sedentary, the incidence of diabetes is increasing, creating a larger market for antidiabetic medications. GLUCOVANCE, being a combination therapy, offers a convenient and effective treatment option, which enhances its market appeal[1][4].

Competitive Landscape

The antidiabetic drug market is highly competitive, with various monotherapies and combination therapies available. GLUCOVANCE competes with other combination drugs as well as newer classes of antidiabetic medications such as SGLT2 inhibitors and GLP-1 receptor agonists. However, its established efficacy and safety profile, along with its cost-effectiveness, help it maintain a significant market share[1].

Financial Performance and Revenue

The financial performance of GLUCOVANCE is tied to the overall sales of its manufacturer and the broader pharmaceutical market. In recent years, the healthcare sector, including pharmaceutical companies, has seen steady growth driven by increasing healthcare spending and the need for effective treatments for chronic diseases like diabetes.

For instance, Merck KGaA, Darmstadt, Germany, which is involved in the distribution and support of various pharmaceutical products, including those for diabetes, reported significant revenue in the healthcare sector. In 2020, the Healthcare segment generated 38% of the Group's sales and 40% of EBITDA pre, indicating a strong financial foundation for drugs like GLUCOVANCE[2].

Distribution and Accessibility

GLUCOVANCE is widely distributed through various channels, including drug stores and retail pharmacies. The drug's availability is enhanced by collaborations between pharmaceutical companies and nonprofit organizations, such as Direct Relief, which have provided millions of tablets to people affected by diabetes, especially during the COVID-19 pandemic[2].

Regulatory Frameworks and Reimbursement Policies

Favorable regulatory frameworks and reimbursement policies play a crucial role in the market dynamics of GLUCOVANCE. Regulatory agencies have streamlined approval processes for antidiabetic medications, and robust reimbursement policies have improved patient access to these drugs. For example, GLUCOVANCE is contraindicated in patients with severe renal impairment, but its use in patients with mild to moderate renal impairment is carefully managed, ensuring that it remains a viable treatment option under appropriate medical supervision[1][4].

Challenges and Contraindications

Despite its benefits, GLUCOVANCE has several contraindications and potential side effects. It is contraindicated in patients with renal disease or renal dysfunction, and its use must be carefully monitored in patients with an estimated glomerular filtration rate (eGFR) between 30 to 45 mL/minute/1.73 m^2. Additionally, the risk of severe hypoglycemia is a significant concern, especially when used in combination with other anti-diabetic medications[1][4].

Future Outlook and Growth Opportunities

The future outlook for GLUCOVANCE remains positive due to the increasing prevalence of type 2 diabetes and the ongoing need for effective and convenient treatment options. As healthcare infrastructure expands in emerging markets, there will be greater demand for essential antidiabetic medications like GLUCOVANCE.

Moreover, strategic alliances and R&D investments aimed at improving drug formulations and delivery mechanisms will continue to drive market growth. For instance, the integration of new technologies and the development of more patient-friendly formulations could enhance the market position of GLUCOVANCE[2][3].

Key Takeaways

• Market Demand: Driven by the growing prevalence of type 2 diabetes.
• Competitive Landscape: Competes with other combination therapies and newer classes of antidiabetic medications.
• Financial Performance: Tied to the overall sales of its manufacturer and the broader pharmaceutical market.
• Distribution and Accessibility: Widely distributed through various channels, including drug stores and retail pharmacies.
• Regulatory Frameworks: Favorable regulatory frameworks and reimbursement policies enhance patient access.
• Challenges and Contraindications: Contraindicated in patients with severe renal impairment and carries a risk of severe hypoglycemia.
• Future Outlook: Positive due to increasing demand and ongoing R&D investments.

FAQs

What is GLUCOVANCE used for?

GLUCOVANCE is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What are the active ingredients in GLUCOVANCE?

The active ingredients in GLUCOVANCE are glyburide and metformin hydrochloride.

What are the contraindications for GLUCOVANCE?

GLUCOVANCE is contraindicated in patients with renal disease or renal dysfunction, particularly those with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m^2.

How does GLUCOVANCE work?

GLUCOVANCE works by combining glyburide, which stimulates insulin release from the pancreas, and metformin, which decreases hepatic glucose production and increases insulin sensitivity.

What are the potential side effects of GLUCOVANCE?

Potential side effects include severe hypoglycemia, especially when used in combination with other anti-diabetic medications, and other adverse reactions such as gastrointestinal disturbances.

Cited Sources

1. GLUCOVANCE - accessdata.fda.gov
2. Annual Financial Statements - EMD Group
3. Glucagon Market Size, Share, Growth | CAGR of 6.7% - marketresearch.biz
4. Glucovance: Package Insert / Prescribing Information - Drugs.com