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Last Updated: January 20, 2020

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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-eight patent family members in thirty-five countries.

The generic ingredient in NESINA is alogliptin benzoate. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alogliptin benzoate profile page.

US ANDA Litigation and Generic Entry Outlook for Nesina

  Start Trial

Nesina was eligible for patent challenges on January 25th, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 16th, 2029. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (alogliptin benzoate), which indicates the potential for near-term generic launch.

Drug patent expirations by year for NESINA
Drug Prices for NESINA

See drug prices for NESINA

Generic Entry Opportunity Date for NESINA
Generic Entry Date for NESINA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NESINA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SanofiPhase 4
TakedaPhase 4
Kun-Ho YoonPhase 4

See all NESINA clinical trials

Recent Litigation for NESINA

Identify potential future generic entrants

District Court Litigation
Case NameDate
TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD.2018-01-03
TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD.2017-09-20
TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD.2017-05-05

See all NESINA litigation

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
6-((3R)-3-aminopiperidin-1-yl)-1-(2-cyanobenzyl)-3-methylpyrimidin-2,4(1H,3H)-dione monobenzoate
850649-62-6
AB1008522
AC-021
AKOS015917686
Alogliptin (Benzoate)
Alogliptin benzoate
Alogliptin benzoate (JAN/USAN)
Alogliptin benzoate [USAN:JAN]
alogliptin monobenzoate
Alogliptin, benzoate
Alogliptin?SYR-322
AM20090704
AN-6359
API0004995
AS-14073
BC202597
BCP08885
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)
Benzonitrile,2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-, monobenzoate
C18H21N5O2.C7H6O2
CHEBI:72324
CHEMBL227529
CS-0761
D06553
DTXSID20582095
EEN99869SC
FT-0686730
HY-A0023
I14-8828
J90037
MolPort-005-933-064
Nesina (TN)
SCHEMBL476231
SYR 322
SYR 322 benzoate
SYR-322
UNII-EEN99869SC
Vipidia (TN)
X4993
Paragraph IV (Patent) Challenges for NESINA
Tradename Dosage Ingredient NDA Submissiondate
NESINA TABLET;ORAL alogliptin benzoate 022271 2017-01-25

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

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 022271-003 Jan 25, 2013   Start Trial   Start Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013   Start Trial   Start Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013   Start Trial   Start Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013   Start Trial   Start Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013   Start Trial   Start Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013   Start Trial   Start Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NESINA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 PA2014045 Lithuania   Start Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571 SPC/GB14/012 United Kingdom   Start Trial PRODUCT NAME: ALOGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/844/001-027 20130923
1586571 2014C/010 Belgium   Start Trial PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
1084705 C300709 Netherlands   Start Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571 PA2014011 Lithuania   Start Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571 92374 Luxembourg   Start Trial PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923
1084705 SPC/GB14/083 United Kingdom   Start Trial PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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