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Fuji
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Moodys
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Generated: February 16, 2019

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ONGLYZA Drug Profile

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When do Onglyza patents expire, and what generic alternatives are available?

Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nineteen patent family members in thirty-nine countries.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

Drug patent expirations by year for ONGLYZA
Generic Entry Opportunity Date for ONGLYZA
Generic Entry Date for ONGLYZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ONGLYZA
Synonyms for ONGLYZA
(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)-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-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; 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
945667-22-1
AB01562984_01
AB01562984_02
AB1008460
AC-6008
AK172048
AKOS015896547
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
CHEMBL385517
D08996
D0K9MY
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
NCGC00242597-01
NSC-760407
NSC760407
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 hydrate
Saxagliptine
SCHEMBL17168
SMR004702984
Tox21_112908
Z2235802036

US Patents and Regulatory Information for ONGLYZA

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 022350-001 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 022350-002 Jul 31, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y 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 Y Y ➤ Try a Free Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes ➤ 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 022350-002 Jul 31, 2009 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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Paragraph IV (Patent) Challenges for ONGLYZA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe ➤ Try a Free Trial

International Patents for ONGLYZA

Country Document Number Estimated Expiration
China 1698601 ➤ Try a Free Trial
South Africa 200609541 ➤ Try a Free Trial
Japan 2003531118 ➤ Try a Free Trial
European Patent Office 1753406 ➤ Try a Free Trial
Japan 5953292 ➤ Try a Free Trial
Russian Federation 2006146971 ➤ Try a Free Trial
Egypt 25854 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for ONGLYZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0028 France ➤ Try a Free Trial PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
2010 00007 Denmark ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
2014 00062 Denmark ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
1261586/01 Switzerland ➤ Try a Free Trial FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
985 Luxembourg ➤ Try a Free Trial 91985, EXPIRES: 20260305
9 Finland ➤ Try a Free Trial
2012 00014 Denmark ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Dow
AstraZeneca
Covington
Boehringer Ingelheim
Mallinckrodt
Argus Health
US Army
US Department of Justice

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