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
Summary for DUETACT
International Patents: | 59 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
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: ⤷ 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
See the table below for patents covering DUETACT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 061195 | COMPOSICION FARMACEUTICA PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES | ⤷ Try a Trial |
Finland | 860232 | ⤷ Try a Trial | |
Spain | 2556244 | ⤷ Try a Trial | |
Spain | 550986 | ⤷ Try a Trial | |
European Patent Office | 2292268 | ⤷ Try a Trial | |
Hungary | E028576 | ⤷ 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 |
---|---|---|---|---|
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 |
1174135 | CA 2009 00045 | Denmark | ⤷ Try a Trial | |
0861666 | SPC/GB07/009 | United Kingdom | ⤷ Try a Trial | SPC/GB07/009: 20070126 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |