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Generated: June 18, 2018

DrugPatentWatch Database Preview

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. Three suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
Drug patent expirations by year for ONGLYZA
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 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 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 Y ➤ 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 Submissiondate
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31

Non-Orange Book US Patents for ONGLYZA

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
8,628,799 Coated tablet formulation and method ➤ Try a Free Trial
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV 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 ONGLYZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
650 Luxembourg ➤ Try a Free Trial 91650, EXPIRES: 20241001
2014043 Lithuania ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
00707 Netherlands ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
9 Finland ➤ 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
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US Department of Justice
Covington
Citi
UBS
Daiichi Sankyo
Fish and Richardson
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