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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.

Summary for Tradename: OSENI

Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details

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, 2013RXNo6,303,640Aug 9, 2016
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-002Jan 25, 2013RXNo8,637,079Jun 4, 2029Y
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 2013RXNoJan 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;ORAL022426-003Jan 25, 20136,150,383<disabled>
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 20136,211,205<disabled>
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-004Jan 25, 20136,271,243<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
7,906,523Dipeptidyl peptidase inhibitors<disabled in preview>
9,044,424Methods of regulating glucose metabolism, and reagents related thereto<disabled in preview>
7,795,428Dipeptidyl 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 Federation2323004<disabled in preview>
European Patent Office0861666<disabled in preview>
Australia2003264609<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
1084705/03Switzerland<disabled>PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
2014 00064Denmark<disabled>PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926
2014 00011Denmark<disabled>PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
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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 verifification 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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