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Medtronic
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Generated: April 22, 2018

DrugPatentWatch Database Preview

NESINA Drug Profile

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Which patents cover Nesina, and what generic alternatives are available?

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

This drug has eighty-six patent family members in thirty-three 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 NESINA
Drug patent expirations by year for NESINA
Pharmacology for NESINA
Synonyms for NESINA
(3R)-1-[3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl]piperidin-3-aminium benzoate
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile benzoate
2-((6-((3R)-3-amino-1-piperidinyl)-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)- pyrimidinyl)methyl)benzonitrile monobenzoate
2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile benzoate
2-[[6-[(3R)-3-Amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]benzonitrile benzoate
2-[[6-[(3R)-3-amino-1-piperidyl]-3-methyl-2,4-dioxo-pyrimidin-1-yl]methyl]benzonitrile; benzoic acid
2-[[6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxopyrimidin-1-yl]methyl]benzonitrile;benzoic acid
2-[6-[3(R)-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-1-ylmethyl]benzonitrile benzoate
6-((3R)-3-aminopiperidin-1-yl)-1-(2-cyanobenzyl)-3-methylpyrimidin-2,4(1H,3H)-dione monobenzoate
850649-62-6
AB1008522
AC-021
AK143301
AKOS015917686
Alogliptin (Benzoate)
Alogliptin benzoate
Alogliptin benzoate (JAN/USAN)
Alogliptin benzoate [USAN:JAN]
alogliptin monobenzoate
Alogliptin, benzoate
ALOGLIPTIN; BENZOIC ACID
Alogliptin?SYR-322
AM20090704
AN-6359
API0004995
AS-14073
BC202597
Benzoic acid--2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile (1/1)
Benzonitrile, 2-((6-((3R)-3-amino-1-piperidinyl)-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl)-, monobenzoate
Benzonitrile, 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-, benzoate (1:1)
C18H21N5O2.C7H6O2
CHEBI:72324
CHEMBL227529
CS-0761
D06553
DTXSID20582095
EEN99869SC
FT-0686730
HE069351
HY-A0023
I14-8828
J90037
MolPort-005-933-064
Nesina (TN)
SCHEMBL476231
SYR 322
SYR-322
UNII-EEN99869SC
Vipidia (TN)
X4993

US Patents and Regulatory Information for NESINA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NESINA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NESINA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 6.25 mg, 12.5 mg and 25 mg ➤ Subscribe 2017-01-25

Non-Orange Book US Patents for 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
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
7,781,584 Dipeptidyl peptidase inhibitors ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NESINA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
374 Luxembourg ➤ Sign Up PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923
C0013 France ➤ Sign Up PRODUCT NAME: ALOGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/844 20130919
1 Finland ➤ Sign Up
0140007 00126 Estonia ➤ Sign Up PRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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