Glimepiride; pioglitazone hydrochloride - Generic Drug Details

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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

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Glossary

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

Expired US Patents for glimepiride; pioglitazone hydrochloride

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

International Patents for glimepiride; pioglitazone hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1677792	PREPARATION SOLIDE COMPRENANT DE LA PIOGLITAZONE, DU GLIMEPIRIDE ET UN ESTER D'ACIDE GRAS DE POLYOXYETHYLENE SORBITAN (SOLID PREPARATION COMPRISING PIOGLITAZONE, GLIMEPIRIDE AND A POLYOXYETHYLENE SORBITAN FATTY ACID ESTER)	⤷ Sign Up
South Africa	200602056	Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester	⤷ Sign Up
South Africa	200805147	Solid preparation	⤷ Sign Up
Costa Rica	10032	PREPARACIÓN SÓLIDA	⤷ Sign Up
Peru	20050923	COMPOSICION SOLIDA QUE COMPRENDE UN SENSIBILIZADOR DE INSULINA, UN SECRETAGOGO DE INSULINA Y UN ESTER DE ACIDOS GRASOS	⤷ Sign Up
New Zealand	546337	Solid preparation comprising an insulin sensitizer such as pioglitazone hydrochloride, an insulin secretagogue such as glimepiride and a polyoxyethylene sorbitan fatty acid ester such as Polysorbate 80	⤷ Sign Up
Norway	340294		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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