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Sitagliptin phosphate - Generic Drug Details

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What are the generic sources for sitagliptin phosphate and what is the scope of sitagliptin phosphate freedom to operate?

Sitagliptin phosphate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-five drug master file entries for sitagliptin phosphate. Three suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for sitagliptin phosphate

US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	35
Suppliers / Packagers:	3
Bulk Api Vendors:	174
Clinical Trials:	9
Patent Applications:	5,872
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sitagliptin phosphate
DailyMed Link:	sitagliptin phosphate at DailyMed

Pharmacology for sitagliptin phosphate

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

Medical Subject Heading (MeSH) Categories for sitagliptin phosphate

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Incretins

Synonyms for sitagliptin phosphate

(1R)-3-oxo-3-[3-(trifluoroethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorobenzyl)propylamine

(2R)-4-Oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine phosphate salt

(2r)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a] pyrazin-7(8h)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

(2R)-4-OXO-4-[3-(TRIFLUOROMETHYL)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL]-1-(2,4,5-TRIFLUOROPHENYL)BUTAN-2-AMINE

(2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine dihydrogenphosphate monohydrate

(2r)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine phosphate salt

(2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-alpha]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

(2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-alpha]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine dihydrogenphosphate monohydrate

(3R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6,7,8-TETRAHYDRO-1,2,4-TRIAZOLO(4,3-A)PYRAZIN-7-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE

(3R)-3-AMINO-1-[3-(TRIFLUOROMETHYL)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL]-4-(2,4,5-TRIFLUOROPHENYL)-1-BUTANONE

(3R)-3-amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-amino-1-[3-(trifluoromethyl)-5H,6H,7H,8H-[1,2,4]triazolo[3,4-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one hydrochloride

(3R)-3-AMINO-1-[3-(TRIFLUOROMETHYL)-5H,6H,7H,8H-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7-YL]-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[3,4-c]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[3,4-c]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one; phosphoric acid

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)-1-butanone; phosphoric acid

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one; phosphoric acid

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one; phosphoric acid; hydrate

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric acid;hydrate

(3R)-3-azanyl-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-[2,4,5-tris(fluoranyl)phenyl]butan-1-one; phosphoric acid

(R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6-DIHYDRO-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE

(R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6-DIHYDRO-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE PHOSPHATE

(R)-3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one phosphate hydra

(R)-3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one phosphate hydrate

(R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

1,2,4-Triazolo(4,3-a)pyrazine, 7-((3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8- tetrahydro-3-(trifluoromethyl)-, phosphate (1:1) monohydrate

1,2,4-Triazolo(4,3-a)pyrazine, 7-((3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydor-3-(trifluoromethyl)-

1x70

4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine phosphate

4-Oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine phosphate

486460-32-6

494P4635I6

654671-77-9

654671-78-0

671S779

671S780

7-((3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)buyl)-5,6,7,8-tetrahydro-3-trifluoromethyl)-1,4-triazolo(4,3-a)

7-((3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4- triazolo(4,3-a)pyrazine monophosphate monohydrate

7-(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate

7-(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate hydrate

7-[(3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine

7-[(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine-phosphate

790712-60-6

847445-79-8

A25516

A835125

AB0006583

AB0007165

AB0028055

AB01563393_01

AB1004599

AB1008523

AB55315

ABP000233

AC-1939

AC1N9ZYR

AC1O52U4

AC1Q7DLF

ACT02665

AJ-26333

AK126749

AK172047

AK198682

AKOS015888724

AKOS015895530

AKOS015896098

AMX10120

AN-1039

AN-10494

AN-404

AOB87362

API0000836

AS-18643

AS-19118

AX8110160

BC677054

BDBM11162

BRD-K19416115-001-01-2

BSPBio_002262

C16H15F6N5O

C16H15F6N5O.H2O.H3O4P

C16H18F6N5O5P

CCG-213562

CHEBI:40237

CHEMBL1201174

CHEMBL1422

CHEMBL393336

CS-2914

CS-2915

CS-3683

CTK8F1330

D06645

D08516

D0P0HH

D0U2JP

DB01261

DTXSID10215789

DTXSID70197572

EC 690-730-1

FT-0649098

FT-0650740

FT-0650741

FT-0693933

Glactiv

GP3542

GQPYTJVDPQTBQC-KLQYNRQASA-N

GTPL6286

HE070595

HE071033

HE375745

HMS2093F20

HSDB 7516

HY-13749

HY-13749A

HY-13749B

I06-1070

I06-1709

IQFYVLUXQXSJJN-SBSPUUFOSA-N

Janumet

Januvia

Januvia (merck & Co.)

Januvia (TN)

KB-144380

KB-45963

KB-60462

KS-00000FHI

KS-00000OSI

KS-1214

LEZ 763

LEZ763

LS-186669

LS-187389

MCULE-2101761133

MFCD09838015

MFCD09952339

MFCD10001393

MFFMDFFZMYYVKS-SECBINFHSA-N

MK 0431

MK 431

MK-0431

MK-0431 phosphate monohydrate

MK-0431 phosphate;MK0431 phosphate;MK 0431 phosphate

MK-431

MK0431

MLS006011959

MolPort-003-666-756

MolPort-006-666-483

MolPort-009-194-222

NCGC00178734-03

ONO-5435

PB17676

PHOSPHORIC ACID SITAGLIPTIN HYDRATE

PHOSPHORIC ACID; SITAGLIPTIN

PubChem18266

PubChem18268

Q-101366

Q-1665

Q-201711

Q-201712

QFP0P1DV7Z

ristaben

RL03803

RL04491

RL04492

RT-015712

S053

s4002

SBI-0206871.P001

SC-19743

SCHEMBL1039535

SCHEMBL17783

SCHEMBL877069

Sitagliptan

Sitagliptin

Sitagliptin (13)

Sitagliptin (Metformin,MK-0431)

Sitagliptin (phosphate monohydrate)

Sitagliptin (phosphate)

Sitagliptin (Prop.INN)

Sitagliptin [INN:BAN]

Sitagliptin monohydrate

sitagliptin monophosphate monohydrate

Sitagliptin phosphate (USAN)

Sitagliptin phosphate [USAN]

sitagliptin phosphate anhydrous

Sitagliptin phosphate hydrate

Sitagliptin phosphate hydrate (JAN)

Sitagliptin phosphate monohydrate

SITAGLIPTIN PHOSPHATE SALT

Sitagliptin phosphate(MK 0431 phosphate)

Sitagliptin/

Sitagliptin/atovastatin

sitagliptina

sitagliptine

sitagliptinum

SMR002546724

SR-05000001748

SR-05000001748-2

ST24035442

ST51052943

ST51053205

Stotigliptin

Tesavel

Triazolopiperazine Analogue 1

TS63EW8X6F

Tube110

UNII-494P4635I6

UNII-QFP0P1DV7Z

UNII-TS63EW8X6F

X4663

Xelevia

Z1541638523

ZINC1489478

Tentative approvals for SITAGLIPTIN PHOSPHATE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		50MG	TABLET;ORAL
		25MG	TABLET;ORAL

US Patents and Regulatory Information for sitagliptin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No			Y	Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No			Y	Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No

Expired US Patents for sitagliptin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006

International Patents for sitagliptin phosphate

Country	Document Number	Estimated Expiration
Peru	06542003
Germany	04029691
Norway	2007010
Poland	367279
Germany	602004008938
European Patent Office	1412357

Supplementary Protection Certificates for sitagliptin phosphate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00705	Netherlands		PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
1084705/01	Switzerland		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
2007006	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321