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DUETACT Drug 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 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.
Summary for DUETACT
| International Patents: | 59 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 104 |
| Patent Applications: | 5,897 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DUETACT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DUETACT |
| DailyMed Link: | DUETACT at DailyMed |
Recent Litigation for DUETACT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Takeda Pharmaceutical Company Limited v. Hetero Drugs Limited | 2011-11-16 |
| Takeda Pharmaceutical Company Limited v. Accord Healthcare, Inc. | 2011-09-12 |
| Takeda Pharmaceutical Company Limited v. Macleods Pharmaceuticals Limited | 2011-05-06 |
Pharmacology for DUETACT
Paragraph IV (Patent) Challenges for DUETACT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DUETACT | TABLET;ORAL | glimepiride; pioglitazone hydrochloride | 021925 | 2009-12-22 |
US Patents and Regulatory Information for DUETACT
| 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 |
Expired US Patents for DUETACT
International Patents for DUETACT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20083104 | Start Trial |
| South Korea | 20080080126 | Start Trial |
| European Patent Office | 1962811 | Start Trial |
| Russian Federation | 2006118786 | Start Trial |
| South Africa | 200805147 | Start Trial |
| Taiwan | I339586 | Start Trial |
| Taiwan | I384985 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
