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OSENI Drug Profile

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Which patents cover Oseni, and what substitute generic drugs are available?

Oseni is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this drug.

This drug has two hundred and thirty patent family members in forty-four countries.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

Summary for Tradename: OSENI

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OSENI at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 2013RXYesNo7,807,689► SubscribeYY ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 25, 2013RXYesNo8,637,079► SubscribeY ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-002Jan 25, 2013RXYesNo6,303,661► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 2013RXYesYes6,303,640► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 2013RXYesNo8,637,079► SubscribeY ► Subscribe
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Expired Patents for Tradename: OSENI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 20136,271,243► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 20136,150,384► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 20136,172,090► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 25, 20136,329,404► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 20136,271,243► Subscribe
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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
7,795,428Dipeptidyl peptidase inhibitors► Subscribe
6,172,089 Pharmaceutical composition► Subscribe
6,218,409 Pharmaceutical composition► Subscribe
6,599,923 Pharmaceutical composition► Subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
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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
Portugal896538► Subscribe
Hong Kong1138188► Subscribe
China102140090► Subscribe
South Africa9605190► Subscribe
Cyprus1111264► Subscribe
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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
0861666/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
1084705/01Switzerland► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
2 5006-2014Slovakia► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
2014 00011Denmark► SubscribePRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
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How our clients use DrugPatentWatch

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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