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Alogliptin benzoate - Generic Drug Details

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Alogliptin benzoate is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred patent family members in thirty-eight countries.

There are eight drug master file entries for alogliptin benzoate. Two suppliers are listed for this compound.

Summary for Generic Name: alogliptin benzoate

Tradenames:3
Patents:20
Applicants:1
NDAs:3
Drug Master File Entries: see list8
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: alogliptin benzoate

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;ORAL022426-002Jan 25, 2013RXNo8,173,663► subscribe ► subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 25, 2013RXNo► subscribe► subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 25, 2013RXNo8,288,539► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: alogliptin benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 20136,303,640► subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 20136,211,205► subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 20136,211,205► subscribe
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Non-Orange Book Patents for Generic Ingredient: alogliptin benzoate

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
6,211,206 Pharmaceutical composition► subscribe
6,251,924 Pharmaceutical composition► subscribe
6,133,295 Pharmaceutical composition► 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 Ingredient: alogliptin benzoate

Country Document Number Estimated Expiration
Japan2005263780► subscribe
Austria401320► subscribe
South Korea20070081135► 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: ALOGLIPTIN BENZOATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00063Denmark► subscribePRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
C/GB14/086United Kingdom► subscribePRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
1084705/05Switzerland► subscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
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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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