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Alogliptin benzoate - Generic Drug Details

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What are the generic drug sources for alogliptin benzoate and what is the scope of alogliptin benzoate freedom to operate?

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.

There are nine drug master file entries for alogliptin benzoate. Two suppliers are listed for this compound.

Summary for alogliptin benzoate

US Patents:	10
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	9
Suppliers / Packagers:	2
Bulk Api Vendors:	50
Clinical Trials:	3
Patent Applications:	28
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate
DailyMed Link:	alogliptin benzoate at DailyMed

Pharmacology for alogliptin benzoate

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

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	022426-003	Jan 25, 2013		RX	Yes	Yes
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No			Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		RX	Yes	No

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
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013

International Patents for alogliptin benzoate

Country	Document Number	Estimated Expiration
China	102134229
Costa Rica	8595
Austria	401320

Supplementary Protection Certificates for alogliptin benzoate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00709	Netherlands		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
2014 00011	Denmark		PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919