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DUETACT Drug Patent Profile

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

Duetact is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in thirty-one countries.

The generic ingredient in DUETACT is glimepiride; pioglitazone hydrochloride. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glimepiride; pioglitazone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Duetact

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DUETACT

International Patents:	59
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	142
Drug Prices:	Drug price information for DUETACT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUETACT
What excipients (inactive ingredients) are in DUETACT?	DUETACT excipients list
DailyMed Link:	DUETACT at DailyMed

See drug prices for DUETACT

Pharmacology for DUETACT

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

Paragraph IV (Patent) Challenges for DUETACT

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 DUETACT

DUETACT is protected by two US patents.

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	021925-001	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
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

Expired US Patents for DUETACT

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

International Patents for DUETACT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100952090
Portugal	1174135
Taiwan	200524641	Solid preparation
South Korea	20070081135
Hong Kong	1010484

Supplementary Protection Certificates for DUETACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0193256	C300038	Netherlands		PRODUCT NAME: PIOGLITAZON, DESGEWENST IN DE VORM VAN EEN FARMACOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/00/151/001 - EU/1/00/151/006 20001011
0193256	SPC/GB01/016	United Kingdom		PRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1174135	C01174135/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0861666	CA 2007 00001	Denmark

DUETACT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of DUETACT

Introduction

DUETACT, a combination of pioglitazone hydrochloride and glimepiride, was approved by the U.S. Food and Drug Administration (FDA) in 2006 for the treatment of type 2 diabetes. This article delves into the market dynamics and financial trajectory of DUETACT, examining its launch, market performance, and the factors influencing its success.

Launch and Initial Market Reception

DUETACT was introduced by Takeda Pharmaceuticals North America, Inc. as a convenient dosing option for patients with type 2 diabetes. The drug combined two widely used antihyperglycemic agents, offering dosages of 30 mg/2 mg and 30 mg/4 mg to be taken once daily[1].

Market Positioning

DUETACT was positioned as a new and convenient option for healthcare providers and patients, enhancing the existing ACTOS portfolio. The combination therapy aimed to improve glycemic control by leveraging the insulin-sensitizing properties of pioglitazone and the insulin-secretagogic properties of glimepiride[2].

Clinical Efficacy and Safety

The efficacy and safety of DUETACT were established through studies on its individual components. Clinical trials demonstrated that the combination of pioglitazone and glimepiride improved glycemic control in patients with inadequately controlled type 2 diabetes. However, common adverse events included upper respiratory infections, weight gain, edema, hypoglycemia, and headache[1][2].

Market Trends in Antidiabetic Drugs

Between 2003 and 2012, the U.S. market for antidiabetic drugs saw significant changes. While metformin use increased by 97%, the use of thiazolidinediones, including pioglitazone, declined. Pioglitazone-containing products peaked in 2008 with 14.2 million prescriptions but declined to 6.8 million by 2012, a drop of 52.1% from the peak[4].

Sales Performance

Despite its initial promise, DUETACT faced challenges in the market. The decline in thiazolidinedione use, partly due to safety concerns such as congestive heart failure associated with pioglitazone, impacted sales. By 2012, the overall market share of thiazolidinediones had significantly decreased, affecting DUETACT's financial trajectory[4].

Competitive Landscape

The antidiabetic drug market is highly competitive, with various classes of drugs including metformin, sulfonylureas, DPP-4 inhibitors, and GLP-1 receptor agonists. The introduction of new drugs and changing regulatory landscapes further complicated the market dynamics for DUETACT. For instance, the decline of rosiglitazone-containing products, another thiazolidinedione, also influenced the market perception of DUETACT[4].

Financial Impact of Safety Concerns

Safety concerns, particularly the risk of congestive heart failure associated with pioglitazone, had a significant financial impact on DUETACT. These concerns led to careful monitoring and potential dose reductions or discontinuations, which could reduce prescription rates and revenue. The need for careful patient monitoring and the potential for adverse events contributed to a cautious approach by healthcare providers, affecting the drug's market performance[5].

Strategic Adjustments

Takeda Pharmaceuticals had to adjust its marketing and sales strategies in response to the declining market share. This included emphasizing the convenience of the combination therapy and the established efficacy of its components. However, these efforts were often overshadowed by the broader decline in thiazolidinedione use.

Regulatory Environment

The regulatory environment played a crucial role in the financial trajectory of DUETACT. FDA warnings and precautions, particularly regarding congestive heart failure, influenced prescribing practices. The FDA's strict monitoring and the requirement for careful patient management added to the drug's challenges in the market[5].

Patient and Physician Preferences

Patient and physician preferences also impacted the sales of DUETACT. As safety concerns grew, many patients and healthcare providers opted for alternative treatments with fewer side effects. This shift in preference further eroded the market share of DUETACT.

Conclusion

The market dynamics and financial trajectory of DUETACT were significantly influenced by a combination of factors, including safety concerns, competitive market pressures, and changing regulatory landscapes. Despite its initial promise as a convenient combination therapy, DUETACT faced substantial challenges that impacted its sales and market position.

Key Takeaways

• Combination Therapy: DUETACT combined pioglitazone and glimepiride to improve glycemic control in type 2 diabetes patients.
• Safety Concerns: Safety issues, particularly the risk of congestive heart failure, negatively impacted sales.
• Market Trends: The decline in thiazolidinedione use and the rise of other antidiabetic drug classes affected DUETACT's market share.
• Regulatory Environment: FDA warnings and precautions influenced prescribing practices.
• Patient and Physician Preferences: Shifts in patient and physician preferences towards safer alternatives further reduced DUETACT's market share.

FAQs

Q: What is DUETACT, and how does it work? A: DUETACT is a combination of pioglitazone hydrochloride and glimepiride, used to control blood sugar levels in type 2 diabetes patients. It works by enhancing peripheral glucose utilization and stimulating insulin release from the pancreas.

Q: What were the common dosages of DUETACT? A: DUETACT was available in two dosages: 30 mg/2 mg and 30 mg/4 mg, taken once daily.

Q: What were the main safety concerns associated with DUETACT? A: The main safety concerns included the risk of congestive heart failure, upper respiratory infections, weight gain, edema, hypoglycemia, and headache.

Q: How did the market trends for antidiabetic drugs impact DUETACT? A: The decline in thiazolidinedione use and the rise of other antidiabetic drug classes significantly impacted DUETACT's market share and sales.

Q: What regulatory challenges did DUETACT face? A: DUETACT faced regulatory challenges including FDA warnings and precautions, particularly regarding the risk of congestive heart failure.

Sources

1. FDA Approves Duetact™ (pioglitazone HCl and glimepiride) - Takeda Pharmaceuticals North America, Inc.
2. DUETACT - accessdata.fda.gov - FDA Label
3. Pharmaceutical Market Dynamics and Strategic Planning: A System Dynamics Perspective - ResearchGate
4. Use of Antidiabetic Drugs in the U.S., 2003–2012 - Diabetes Care
5. Duetact (Pioglitazone Hydrochloride and Glimepiride Tablets) - RxList - RxList