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Generated: August 21, 2018

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Sitagliptin phosphate - Generic Drug Details

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What are the generic drug sources for sitagliptin phosphate and what is the scope of sitagliptin phosphate patent protection?

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.

Sitagliptin phosphate has one hundred and forty-one patent family members in forty-five countries.

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

Pharmacology for sitagliptin phosphate
Medical Subject Heading (MeSH) Categories for sitagliptin phosphate
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
➤ Try a Free Trial➤ Try a Free Trial25MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial100MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET;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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No ➤ 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 sitagliptin phosphate

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

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
8,168,637 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes ➤ Try a Free Trial
8,440,668 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes ➤ 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 sitagliptin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
C0041 France ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
00287 Netherlands ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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