Glimepiride; pioglitazone hydrochloride - Generic Drug Details

What are the generic sources for glimepiride; pioglitazone hydrochloride and what is the scope of freedom to operate?

Glimepiride; pioglitazone hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Sandoz, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Glimepiride; pioglitazone hydrochloride has fifty-nine patent family members in thirty-one countries.

Three suppliers are listed for this compound.

Summary for glimepiride; pioglitazone hydrochloride

International Patents:	59
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for glimepiride; pioglitazone hydrochloride
DailyMed Link:	glimepiride; pioglitazone hydrochloride at DailyMed

Recent Clinical Trials for glimepiride; pioglitazone hydrochloride

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

Sponsor	Phase
Seoul National University Hospital	Phase 4
Kanazawa University	Phase 4
Kowa Company, Ltd.	Phase 4

See all glimepiride; pioglitazone hydrochloride clinical trials

Pharmacology for glimepiride; pioglitazone hydrochloride

Drug Class	Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Sulfonylurea Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity

Anatomical Therapeutic Chemical (ATC) Classes for glimepiride; pioglitazone hydrochloride

A10BB	Sulfonylureas
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUETACT	Tablets	glimepiride; pioglitazone hydrochloride	30 mg/2 mg and 30 mg/4 mg	021925	1	2009-12-22

US Patents and Regulatory Information for glimepiride; pioglitazone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No			Y
Sandoz	PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	201049-001	Jan 4, 2013	AB	RX	No	No
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes			Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No			Y
Sandoz	PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	201049-002	Jan 4, 2013	AB	RX	No	No
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes			Y

Expired US Patents for glimepiride; pioglitazone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006

International Patents for glimepiride; pioglitazone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Croatia	P20151447
Ukraine	91729	ТВЕРДАЯ ФОРМА ЛЕКАРСТВЕННОГО ПРЕПАРАТА;ТВЕРДА ФОРМА ЛІКАРСЬКОГО ПРЕПАРАТУ (SOLID PREPARATION)
Georgia, Republic of	P20084570	SOLID PREPARATION COMPRISING AN INSULIN SENSITIZER, AN INSULIN SECRETAGOGUE AND A POLYOXYETHYLENE SORBITAN FATTY ACID ESTER
Brazil	PI0414979	preparação sólida
South Korea	100952090
Spain	2556244
Brazil	PI0620020	preparação sólida, e, partìcula revestida

Glimepiride; pioglitazone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glimepiride and Pioglitazone Hydrochloride

Introduction

Glimepiride and pioglitazone hydrochloride are two antidiabetic medications that have been widely used in the management of type 2 diabetes. Understanding their market dynamics and financial trajectory is crucial for pharmaceutical companies, healthcare providers, and investors.

Market Overview

Glimepiride

Glimepiride is a sulfonylurea that stimulates insulin secretion from the pancreas. It is commonly used as a monotherapy or in combination with other antidiabetic agents. The market for glimepiride is well-established, given its long history of use and generic availability, which has driven down costs and increased accessibility[2].

Pioglitazone Hydrochloride

Pioglitazone, a thiazolidinedione (TZD), works by increasing insulin sensitivity in the body. It is often used in combination with other medications, including glimepiride. Pioglitazone has shown significant benefits in reducing the progression of cardiovascular events and improving lipid profiles, which has contributed to its market presence[1][3][5].

Combination Therapy: Pioglitazone + Glimepiride

The combination of pioglitazone and glimepiride is approved in many countries and is known for its synergistic effects in managing type 2 diabetes. This combination increases the body's sensitivity to insulin, reduces HbA1c levels, and has favorable effects on lipid profiles and blood pressure. The market for this combination is robust due to its clinical efficacy and the convenience of a single formulation[2][5].

Clinical Efficacy and Market Impact

Cardiovascular Benefits

Pioglitazone has been shown to significantly lower the risk of certain cardiovascular events, such as myocardial infarction, stroke, and acute coronary syndrome. This macrovascular benefit is a key differentiator in the market, making pioglitazone a preferred choice for patients with high cardiovascular risk[1][3][4].

Glycemic Control

Both glimepiride and pioglitazone are effective in reducing HbA1c levels, but pioglitazone has an additional benefit of stabilizing pancreatic β-cell function, which helps in maintaining long-term glycemic control. This aspect enhances the market appeal of pioglitazone, especially in patients with a history of macrovascular disease[1][3].

Lipid Profile and Blood Pressure

Pioglitazone increases high-density lipoprotein (HDL) cholesterol levels and decreases triglycerides, which are favorable effects on lipid profiles. Additionally, it has a smaller increase in systolic blood pressure compared to glimepiride. These benefits contribute to its market traction[1][4].

Financial Trajectory

Cost-Effectiveness

Studies have shown that while the direct medical costs for pioglitazone treatment are marginally higher than those for glimepiride, the long-term benefits in terms of reduced diabetes complications and improved quality-adjusted life years (QALYs) make pioglitazone a cost-effective option. For instance, in the German setting, the incremental cost-effectiveness ratio (ICER) for pioglitazone was estimated to be around €13,294 per QALY gained, which is considered good value for money[3].

Market Pricing

The combination of pioglitazone and glimepiride is available in various formulations and from multiple manufacturers, which has led to competitive pricing. In India, for example, the prices of these combination drugs range from ₹40 to ₹1,641, depending on the manufacturer and formulation[2].

Revenue and Market Share

The revenue generated from these medications is substantial due to their widespread use. Pioglitazone, in particular, has seen significant market share due to its unique benefits in cardiovascular risk reduction and glycemic control. The combination therapy of pioglitazone and glimepiride continues to be a revenue driver for pharmaceutical companies, especially in regions where type 2 diabetes is prevalent.

Side Effects and Safety Considerations

Hypoglycemia and Weight Gain

Glimepiride is associated with a higher risk of hypoglycemia compared to pioglitazone. On the other hand, pioglitazone is linked with weight gain, edema, and an increased risk of fractures and heart failure. These side effects can impact the market dynamics, as healthcare providers and patients weigh the benefits against the risks[1][2][5].

Regulatory and Guidelines Impact

Guidelines and Recommendations

Guidelines from various health organizations recommend the use of pioglitazone in patients with type 2 diabetes who are at high risk of cardiovascular events. These recommendations influence market demand and prescribing patterns. For instance, guidelines may limit the use of pioglitazone in patients with certain cardiac risk factors, which can affect its market share[5].

Future Outlook

Emerging Markets

The growing prevalence of type 2 diabetes in emerging markets presents a significant opportunity for the growth of glimepiride and pioglitazone. As healthcare systems in these regions improve, the demand for effective antidiabetic medications is expected to increase.

Generic Competition

The availability of generic versions of both glimepiride and pioglitazone will continue to shape the market. Generic competition can drive down prices, making these medications more accessible but also potentially reducing the revenue for branded versions.

Innovative Formulations

The development of new formulations and combinations that address the side effects and improve the efficacy of these medications could further enhance their market position. For example, formulations that mitigate the risk of heart failure associated with pioglitazone could increase its adoption.

Key Takeaways

• Clinical Efficacy: Pioglitazone offers significant cardiovascular benefits and improves glycemic control, making it a preferred choice for patients with high cardiovascular risk.
• Cost-Effectiveness: Despite higher direct costs, pioglitazone is considered cost-effective due to its long-term benefits in reducing diabetes complications.
• Market Pricing: Competitive pricing due to multiple manufacturers and generic availability affects the revenue and market share of these medications.
• Side Effects: Both medications have distinct side effect profiles that influence their market dynamics.
• Regulatory Impact: Guidelines and recommendations from health organizations significantly influence the market demand and prescribing patterns.

FAQs

Q: What are the primary differences in how glimepiride and pioglitazone work? A: Glimepiride stimulates insulin secretion from the pancreas, while pioglitazone increases insulin sensitivity in the body by stimulating the peroxisome proliferator-activated receptor-γ (PPAR-γ)[1][5].

Q: Which medication has a better safety profile in terms of cardiovascular events? A: Pioglitazone has been shown to reduce the risk of certain cardiovascular events, such as myocardial infarction and stroke, more effectively than glimepiride[1][3][4].

Q: How does the combination of pioglitazone and glimepiride affect lipid profiles? A: The combination increases HDL cholesterol levels and decreases triglycerides, which are favorable effects on lipid profiles[1][5].

Q: What are the common side effects associated with the combination of pioglitazone and glimepiride? A: Common side effects include hypoglycemia, weight gain, upper respiratory tract infection, and lower limb edema. Pioglitazone is also associated with an increased risk of fractures and heart failure[2][5].

Q: Is the combination of pioglitazone and glimepiride cost-effective? A: Yes, despite higher direct medical costs, the combination is considered cost-effective due to its long-term benefits in reducing diabetes complications and improving quality-adjusted life years (QALYs)[3].

Sources

1. Comparison of Pioglitazone vs Glimepiride on Progression of Coronary Atherosclerosis - JAMA Network[1]
2. Pioglitazone + Glimepiride: View Uses, Side Effects and Medicines - 1mg.com[2]
3. Cost-effectiveness of pioglitazone in type 2 diabetes patients - NCBI[3]
4. Effect of Pioglitazone Compared With Glimepiride on Carotid Intima-Media Thickness - JAMA Network[4]
5. Pioglitazone hydrochloride/glimepiride - PubMed[5]