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DUETACT Drug Patent Profile

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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

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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

Drug patent expirations by year 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.

Patents protecting DUETACT

Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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	021925-001	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
>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 DUETACT

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DUETACT

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

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Country	Patent Number	Title	Estimated Expiration
Malaysia	149306	SOLID PREPARATION CONTAINING AN INSULIN SENSITIZER	⤷ Sign Up
New Zealand	569071	Solid preparation containing an insulin sensitizer	⤷ Sign Up
Ireland	58928	Thiazolidinedione derivatives, their production and use	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DUETACT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	07C0006	France	⤷ Sign Up	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
0193256	C300038	Netherlands	⤷ Sign Up	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	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description