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OSENI Drug Profile

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Oseni is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug.

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.

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;ORAL022426-001Jan 25, 2013RXNo6,303,640<disabled> <disabled>
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-002Jan 25, 2013RXNo8,637,079<disabled>Y <disabled>
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 2013RXNo<disabled><disabled>
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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;ORAL022426-002Jan 25, 20136,166,043<disabled>
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-002Jan 25, 20136,211,205<disabled>
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 20136,150,383<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
6,599,923 Pharmaceutical composition<disabled in preview>
6,172,089 Pharmaceutical composition<disabled in preview>
7,906,523Dipeptidyl 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
Austria488227<disabled in preview>
Germany122009000064<disabled in preview>
Taiwan438587<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
C0035France<disabled>PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
1084705/05Switzerland<disabled>PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
C0008France<disabled>PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
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