DUETACT Drug Patent Profile
✉ Email this page to a colleague
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
Summary for DUETACT
International Patents: | 60 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Patent Applications: | 2,470 |
Formulation / Manufacturing: | see details |
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 |


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