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Generated: September 21, 2018

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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.

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.

Drug patent expirations by year 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.

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
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
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 022271-002 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 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 Date
➤ Subscribe Tablets 6.25 mg, 12.5 mg and 25 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for NESINA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014011,C1586571 Lithuania ➤ Sign Up PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
C0013 France ➤ Sign Up PRODUCT NAME: ALOGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/844 20130919
C/GB14/083 United Kingdom ➤ Sign Up PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1084705/05 Switzerland ➤ Sign Up PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
2014 00066 Denmark ➤ Sign Up PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
2014045 Lithuania ➤ Sign Up PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Moodys
McKinsey
Chinese Patent Office
Fuji
Dow
Cerilliant
Cantor Fitzgerald
Harvard Business School

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