➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Express Scripts
Colorcon
Harvard Business School
McKesson

Last Updated: January 19, 2021

DrugPatentWatch Database Preview

DUETACT Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 sixty 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.

US ANDA Litigation and Generic Entry Outlook for Duetact

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Paragraph IV (Patent) Challenges for DUETACT
Tradename Dosage Ingredient NDA Submissiondate
DUETACT TABLET;ORAL glimepiride; pioglitazone hydrochloride 021925 2009-12-22

US Patents and Regulatory Information for DUETACT

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   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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

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

Supplementary Protection Certificates for DUETACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1174135 C01174135/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0861666 07C0006 France   Start Trial 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
0861666 300258 Netherlands   Start Trial 300258, 20160620, EXPIRES: 20210619
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
AstraZeneca
Express Scripts
Medtronic
Moodys

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.