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DUETACT Drug Profile
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See Plans and PricingWhich 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.
US ANDA Litigation and Generic Entry Outlook for Duetact
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for DUETACT
| International Patents: | 60 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 107 |
| Patent Applications: | 7,114 |
| 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
| 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 | Start Trial | Start Trial |
| Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | Start Trial | Start Trial |
| Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | Start Trial | Start Trial |
| Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DUETACT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Morocco | 30061 | Start Trial |
| Australia | 2006328328 | Start Trial |
| Canada | 2633149 | Start Trial |
| Russian Federation | 2426530 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
