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 | ||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DUETACT
See the table below for patents covering DUETACT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2426530 | ТВЕРДЫЙ ПРЕПАРАТ (HARD MEDICATION) | ⤷ Try a Trial |
| Slovakia | 287287 | ⤷ Try a Trial | |
| China | 1145783 | ⤷ 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 | SPC026/2009 | Ireland | ⤷ Try a Trial | SPC026/2009: 20101001, EXPIRES: 20210619 |
| 0861666 | CA 2007 00001 | Denmark | ⤷ Try a Trial | |
| 1174135 | SPC/GB10/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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