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. Two 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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Questions you can ask:
- What is the 5 year forecast for DUETACT?
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Summary for DUETACT
| International Patents: | 59 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DUETACT |
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.
| 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 | ||
| 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 | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DUETACT
See the table below for patents covering DUETACT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 240698 | PROCEDIMIENTO PARA PREPARAR COMPUESTOS DE 5-(4-(2-(5-ETIL-2-PIRIDIL)-ETOXI)BENZIL)-2,4-TIAZOLIDINDIONA Y SUS SALES (PROCESS FOR THE PREPARATION OF 5-(4-(2-(5-ETHYL-2-PYRIDIL)-ETHOXY)BENZYL)-2,4-THIAZOLODINEDIONE AND THEIR SALTS) | ⤷ Start Trial |
| Austria | 41931 | ⤷ Start Trial | |
| Australia | 5246786 | ⤷ Start Trial | |
| Australia | 572719 | ⤷ Start Trial | |
| Brazil | 1100325 | ⤷ Start Trial | |
| Canada | 1277323 | DERIVES DE THIAZOLIDINEDIONE, LEUR PRODUCTION ET LEUR EMPLOI (THIAZOLIDINEDIONE DERIVATIVES, THEIR PRODUCTION AND USE) | ⤷ Start Trial |
| China | 1003934 | ⤷ Start 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 | ⤷ Start 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 |
| 0861666 | CA 2007 00001 | Denmark | ⤷ Start Trial | |
| 0861666 | 300258 | Netherlands | ⤷ Start Trial | 300258, 20160620, EXPIRES: 20210619 |
| 1174135 | 437 | Finland | ⤷ Start Trial | |
| 1174135 | CA 2009 00045 | Denmark | ⤷ Start Trial | |
| 0861666 | SPC 038/2006 | Ireland | ⤷ Start Trial | SPC 038/2006: 20070528, EXPIRES: 20210619 |
| 0861666 | C00861666/01 | Switzerland | ⤷ Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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