Details for New Drug Application (NDA): 021925

NDA 021925 describes DUETACT, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DUETACT profile page.

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

Summary for 021925

Tradename:	DUETACT
Applicant:	Takeda Pharms Usa
Ingredient:	glimepiride; pioglitazone hydrochloride
Patents:	2

Pharmacology for NDA: 021925

Mechanism of Action

Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

Suppliers and Packaging for NDA: 021925

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925	NDA	Takeda Pharmaceuticals America, Inc.	64764-302	64764-302-30	30 TABLET in 1 BOTTLE (64764-302-30)
DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925	NDA	Takeda Pharmaceuticals America, Inc.	64764-302	64764-302-90	90 TABLET in 1 BOTTLE (64764-302-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG;30MG
Approval Date:	Jul 28, 2006	TE:	AB	RLD:	Yes
Patent:	7,700,128	Patent Expiration:	Jan 30, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,071,130	Patent Expiration:	Jun 8, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG;30MG
Approval Date:	Jul 28, 2006	TE:	AB	RLD:	Yes
Patent:	7,700,128	Patent Expiration:	Jan 30, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021925

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	6,329,404
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	6,150,383
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	6,329,404
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	4,687,777
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	7,538,125
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	6,211,205
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	7,538,125

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