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OSENI Drug Profile
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This drug has two hundred and twenty-nine patent family members in forty-four countries.
The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.
Summary for Tradename: OSENI
| Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: : | see details |
Pharmacology for Tradename: OSENI
Clinical Trials for: OSENI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-001 | Jan 25, 2013 | RX | No | 6,303,640 | Aug 9, 2016 | ||||||||||||||||||||
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-002 | Jan 25, 2013 | RX | No | 8,637,079 | Jun 4, 2029 | Y | |||||||||||||||||||
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-005 | Jan 25, 2013 | RX | No | Jan 25, 2018 | |||||||||||||||||||||
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Expired Patents for Tradename: OSENI
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-003 | Jan 25, 2013 | 6,150,383 | <disabled> | ||||||||||||||||||||||
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-003 | Jan 25, 2013 | 6,211,205 | <disabled> | ||||||||||||||||||||||
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-004 | Jan 25, 2013 | 6,271,243 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Tradename: OSENI
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,906,523 | Dipeptidyl peptidase inhibitors | <disabled in preview> | |||||||||||||||||||||||||||
| 9,044,424 | Methods of regulating glucose metabolism, and reagents related thereto | <disabled in preview> | |||||||||||||||||||||||||||
| 7,795,428 | Dipeptidyl peptidase inhibitors | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: OSENI
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2323004 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 0861666 | <disabled in preview> | |||||||||||||||||||||||||||
| Australia | 2003264609 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: OSENI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1084705/03 | Switzerland | <disabled> | PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010 | ||||||||||||||||||||||||||
| 2014 00064 | Denmark | <disabled> | PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926 | ||||||||||||||||||||||||||
| 2014 00011 | Denmark | <disabled> | PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919 | ||||||||||||||||||||||||||
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