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Generated: May 24, 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 twenty-two patent family members in forty 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)-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,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)-
361442-04-8
8I7IO46IVQ
AB01562984_01
AB01562984_02
AB1008460
AC-6008
AKOS015896547
AM20090693
AN-5808
BDBM11542
BDBM50225074
BMS 477118
BMS-477118
BMS-477118-11
BMS477118
BRD-A81513827-001-03-6
CAS-361442-04-8
cc-226
CCG-213084
CHEBI:71272
CHEMBL385517
D08996
DB06335
DSSTox_CID_28506
DSSTox_GSID_48580
DSSTox_RID_82778
DTXSID7048580
EX-7795
GTPL6316
HMS3264P11
HSDB 8199
I06-2477
MLS006011223
MolPort-021-783-241
NCGC00242597-01
NCGC00242597-02
NSC-760407
NSC760407
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
Saxagliptine
SCHEMBL17168
SCHEMBL20243458
SMR004702984
Tox21_112908
UNII-8I7IO46IVQ
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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up

Supplementary Protection Certificates for ONGLYZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 CR 2014 00062 Denmark ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1261586 2010C/008 Belgium ➤ Sign Up PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1261586 SPC005/2010 Ireland ➤ Sign Up SPC005/2010: 20100702, EXPIRES: 20240930
1261586 CA 2010 00007 Denmark ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
1261586 C01261586/01 Switzerland ➤ Sign Up FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
1261586 91985 Luxembourg ➤ Sign Up 91985, EXPIRES: 20260305
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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