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Last Updated: September 29, 2023

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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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

International Patents for DUETACT

When does loss-of-exclusivity occur for DUETACT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 6210
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 04285354
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0414979
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 40225
Estimated Expiration: ⤷  Try a Trial

China

Patent: 74774
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0151447
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17176
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 77792
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 77792
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0084570
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 28576
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4201
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 61461
Estimated Expiration: ⤷  Try a Trial

Patent: 05154418
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 06
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06004639
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 116
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 6337
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 0294
Estimated Expiration: ⤷  Try a Trial

Patent: 062515
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 050923
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 77792
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 77792
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 59661
Estimated Expiration: ⤷  Try a Trial

Patent: 06118786
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 77792
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0602056
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 0952090
Estimated Expiration: ⤷  Try a Trial

Patent: 060061383
Estimated Expiration: ⤷  Try a Trial

Patent: 100012105
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 56244
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 39586
Estimated Expiration: ⤷  Try a Trial

Patent: 0524641
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
European Patent Office 2292268 ⤷  Try a Trial
Portugal 1677792 ⤷  Try a Trial
Argentina 005641 COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLICEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE DIABETES ⤷  Try a Trial
Mexico 9202933 DERIVADOS DE TIAZOLIDINDIONA. ⤷  Try a Trial
Russian Federation 2006118786 ТВЕРДЫЙ ПРЕПАРАТ ⤷  Try a Trial
South Africa 9605190 ⤷  Try a Trial
Norway 962606 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUETACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0193256 C300038 Netherlands ⤷  Try a Trial 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
1174135 C01174135/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0861666 CA 2007 00001 Denmark ⤷  Try a Trial
0861666 07C0006 France ⤷  Try a 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 291 Finland ⤷  Try a Trial
0193256 SPC/GB01/016 United Kingdom ⤷  Try a Trial 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
0861666 C00861666/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
AstraZeneca
Express Scripts
Medtronic
Moodys

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