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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021925

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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. Three 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 Activity

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:	⤷ Sign Up	Patent Expiration:	Jan 30, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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:	⤷ Sign Up	Patent Expiration:	Jan 30, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021925

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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	021925-001	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
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	021925-002	Jul 28, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.