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Last Updated: February 21, 2020

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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 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-five patent family members in forty countries.

There are fifteen drug master file entries for saxagliptin hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for saxagliptin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityN/A
Sabyasachi SenPhase 3
Sabyasachi SenPhase 4

See all saxagliptin hydrochloride clinical trials

Recent Litigation for saxagliptin hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca AB v. Mylan Pharmaceuticals Inc.2014-06-03
AstraZeneca AB v. Mylan Pharmaceuticals Inc.2014-06-02
AstraZeneca AB v. Glenmark Generics Ltd.2014-05-23

See all saxagliptin hydrochloride litigation

PTAB Litigation
PetitionerDate
2016-06-02
2016-06-01
2016-05-11

See all saxagliptin hydrochloride litigation

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
Paragraph IV (Patent) Challenges for SAXAGLIPTIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ONGLYZA TABLET;ORAL saxagliptin hydrochloride 022350 2013-07-31

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 022350-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 15/2012 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1084705 C01084705/03 Switzerland   Start Trial PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
1261586 1290013-0 Sweden   Start Trial PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Moodys
Harvard Business School
AstraZeneca
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.