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Last Updated: May 20, 2022

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 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.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 04285354
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0414979
Estimated Expiration: See Plans and Pricing

Canada

Patent: 40225
Estimated Expiration: See Plans and Pricing

China

Patent: 74774
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151447
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17176
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 77792
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 77792
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0084570
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 28576
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4201
Estimated Expiration: See Plans and Pricing

Japan

Patent: 61461
Estimated Expiration: See Plans and Pricing

Patent: 05154418
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 06
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06004639
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 116
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6337
Estimated Expiration: See Plans and Pricing

Norway

Patent: 0294
Estimated Expiration: See Plans and Pricing

Patent: 062515
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050923
Estimated Expiration: See Plans and Pricing

Poland

Patent: 77792
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 77792
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 59661
Estimated Expiration: See Plans and Pricing

Patent: 06118786
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 77792
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0602056
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0952090
Estimated Expiration: See Plans and Pricing

Patent: 060061383
Estimated Expiration: See Plans and Pricing

Patent: 100012105
Estimated Expiration: See Plans and Pricing

Spain

Patent: 56244
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 39586
Estimated Expiration: See Plans and Pricing

Patent: 0524641
Estimated Expiration: See Plans and Pricing

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
China 1003934 See Plans and Pricing
Latvia 5779 Tiazolidindiona atvasinajumi ar antidiabetiskam ipasibam See Plans and Pricing
Mexico 9602399 COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.) See Plans and Pricing
Argentina 005641 COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLICEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE DIABETES See Plans and Pricing
Mexico 9202933 DERIVADOS DE TIAZOLIDINDIONA. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUETACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0861666 C00861666/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0193256 SPC/GB01/016 United Kingdom See Plans and Pricing 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 SPC/GB07/009 United Kingdom See Plans and Pricing SPC/GB07/009: 20070126
1174135 CA 2009 00045 Denmark See Plans and Pricing
0193256 C300038 Netherlands See Plans and Pricing 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
>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.