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NESINA Drug Profile

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

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

This drug has two hundred and one patent family members in thirty-eight countries.

The generic ingredient in NESINA is alogliptin benzoate. 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 profile page.

Summary for Tradename: NESINA

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list32
Clinical Trials: see list11
Patent Applications: see list14
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NESINA at DailyMed

Pharmacology for Tradename: NESINA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes7,807,689► SubscribeYY ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes8,173,663► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo6,303,640► Subscribe ► Subscribe
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Expired Patents for Tradename: NESINA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 20136,329,404► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 20136,329,404► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 20136,303,640► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 20136,150,383► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 20136,329,404► Subscribe
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Non-Orange Book Patents for Tradename: NESINA

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
6,384,062 Pharmaceutical composition► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,133,295 Pharmaceutical composition► Subscribe
6,225,326 Pharmaceutical composition► Subscribe
6,911,459 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 Tradename: NESINA

Country Document Number Estimated Expiration
South Africa9605190► Subscribe
Morocco28469► Subscribe
Serbia50621► Subscribe
Argentina048055► Subscribe
China1530106► 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: NESINA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140007 00126Estonia► SubscribePRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
2014 00065Denmark► SubscribePRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110830
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
2 5006-2014Slovakia► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 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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