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Generated: July 18, 2019

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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 twenty-two patent family members in forty countries.

There are fifteen drug master file entries for saxagliptin hydrochloride. Two 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 hydrochloride
(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 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 hydrochloride
709031-78-7
AC-25294
AK172328
AKOS025290185
AKOS025401759
AS-35106
BCP21271
BMS 477118
CHEMBL1201743
CS-0006342
D10262
DS-8019
MolPort-039-136-984
MolPort-044-813-642
Onglyza (TN)
Saxagliptin HCl
SB20300
SCHEMBL15152103
TUAZNHHHYVBVBR-NHKADLRUSA-N
Tube111
UNII-Z8J84YIX6L
UNII-Z8J84YIX6L component TUAZNHHHYVBVBR-ZBMKVBKGSA-N
Z6172
Z8J84YIX6L

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
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 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
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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Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 SZ 4/2010 Austria ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
1261586 2012C/016 Belgium ➤ Try a Free Trial PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1261586 SPC/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 C01261586/01 Switzerland ➤ Try a Free Trial FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
1261586 2010C/008 Belgium ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1084705 PA2014043 Lithuania ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1084705 CA 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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