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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
McKinsey
McKesson
QuintilesIMS
Cerilliant
Johnson and Johnson
Covington
Moodys

Generated: July 18, 2018

DrugPatentWatch Database Preview

Saxagliptin hydrochloride - Generic Drug Details

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What are the generic drug sources for saxagliptin hydrochloride and what is the scope of saxagliptin hydrochloride patent protection?

Saxagliptin hydrochloride
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Saxagliptin hydrochloride has one hundred and nineteen patent family members in thirty-nine countries.

There are fifteen drug master file entries for saxagliptin hydrochloride. Three suppliers are listed for this compound.
Pharmacology for saxagliptin hydrochloride
Synonyms for saxagliptin hydrochloride
(1S,3S,5S)-2-((2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl)-2-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,3S,5S)-2-((2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl)-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrochloride
(1S,3S,5S)-2-((2S)-Amino(3-hydroxytricyclo(3.3.1.13,7)dec-1-yl)acetyl)-2-azabicyclo(3.1.0)hexane-3-carbonitrile
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile;hydrochloride
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrochloride
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile; 2,2,2-trifluoroacetic acid
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)-1-oxoethyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile; Onglyza
(1S,3S,5S)-2-[(S)-2-amino-2-(3-hydroxy-adamantan-1-yl)-acetyl]-2-aza-bicyclo[3.1.0]hexane-3-carbonitrile
(1s,3s,5s)-2-[2(s)-amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,3S,5S)-4-[(2S)-2-amino-2-(3-hydroxy-1-adamantyl)acetyl]-4-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,5S)-2-[2-amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
(1S,6S)-2-(2-adamantan-1-yl-2-amino-acetyl)-2-aza-bicyclo[3.1.0]hexane-3-carbonitrile
(S)-3-Hydroxyadamantylglycine-L-cis-4,5-methanoprolinenitrile TFA salt
2-Azabicyclo(3.1.0)hexane-3-carbonitrile, 2-((2S)-amino(3-hydroxytricyclo(3.3.1.13,7)dec-1-yl)acetyl) , (1S,3S,5S)-
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1S,3S,5S)-
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-amino(3-hydroxytricyclo[3.3
361442-04-8
709031-78-7
945667-22-1
AB01562984_01
AB01562984_02
AB1008460
AC-6008
AK172048
AK172328
AKOS015896547
AKOS025290185
AM20090693
AN-5808
BDBM11542
BDBM50225074
BMS 477118
BMS 477118-11
BMS-477118
BMS-477118-11
BMS477118
CAS-361442-04-8
cc-226
CCG-213084
CHEBI:71272
CHEMBL1201743
CHEMBL385517
D08996
D0K9MY
D10262
DB06335
DSSTox_CID_28506
DSSTox_GSID_48580
DSSTox_RID_82778
DTXSID7048580
EX-7795
GTPL6316
HMS3264P11
HSDB 8199
I06-2477
Kombiglyze XR (TN)
MLS006011223
MolPort-021-783-241
MolPort-039-136-984
MolPort-044-813-642
NCGC00242597-01
NSC-760407
NSC760407
Onglyza
Onglyza (TN)
OPC 262
OPC-262
Pharmakon1600-01502500
Q-4418
QGJUIPDUBHWZPV-SGTAVMJGSA-N
s1540
Saxagliptin
Saxagliptin - BMS-477118
Saxagliptin (BMS-477118,Onglyza)
Saxagliptin (INN)
Saxagliptin [INN]
Saxagliptin anhydrous
Saxagliptin HCl
Saxagliptin hydrate
Saxagliptine
SCHEMBL15152103
SCHEMBL17168
SMR004702984
Tox21_112908
TUAZNHHHYVBVBR-NHKADLRUSA-N
Z2235802036

US Patents and Regulatory Information for saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 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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Non-Orange Book US Patents for saxagliptin hydrochloride

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
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method ➤ Try a Free Trial
8,628,799 Coated tablet formulation and method ➤ Try a Free Trial
9,339,472 Coated tablet formulation and method ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for saxagliptin hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4/2010 Austria ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
C/GB10/001 United Kingdom ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
1261586/01 Switzerland ➤ Try a Free Trial FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
2014043 Lithuania ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Chinese Patent Office
Federal Trade Commission
Johnson and Johnson
Merck
Medtronic
Argus Health
Covington
Farmers Insurance

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