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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Baxter
Fuji
Merck
Fish and Richardson
Medtronic
Accenture
Mallinckrodt
Daiichi Sankyo

Generated: April 23, 2018

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Alogliptin benzoate - Generic Drug Details

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What are the generic sources for alogliptin benzoate and what is the scope of alogliptin benzoate patent protection?

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

Alogliptin benzoate has eighty-six patent family members in thirty-three countries.

There are nine drug master file entries for alogliptin benzoate. Two suppliers are listed for this compound.
Summary for alogliptin benzoate
Pharmacology for alogliptin benzoate
Synonyms for alogliptin benzoate
(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 (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
Nesina (TN)
SCHEMBL476231
SYR 322
SYR-322
UNII-EEN99869SC
Vipidia (TN)
X4993

US Patents and Regulatory Information for alogliptin benzoate

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 OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-006 Jan 25, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 alogliptin benzoate

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

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Non-Orange Book US Patents for 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
8,329,900 Dipeptidyl peptidase inhibitors ➤ Try a Free Trial
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
6,803,357 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for alogliptin benzoate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00066 Denmark ➤ Try a Free Trial PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
C/GB14/083 United Kingdom ➤ Try a Free Trial PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
00640 Netherlands ➤ Try a Free Trial PRODUCT NAME: ALOGLIPTINE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
2 5006-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Medtronic
Julphar
Covington
Citi
Fish and Richardson
Harvard Business School
Johnson and Johnson
Healthtrust

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