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Last Updated: October 24, 2021

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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-six 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
Beni-Suef UniversityPhase 4

See all SAXAGLIPTIN HYDROCHLORIDE clinical trials

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

Expired US Patents for SAXAGLIPTIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SAXAGLIPTIN HYDROCHLORIDE

Country Patent Number Estimated Expiration
Germany 60134122 ⤷  Free Forever Trial
Norway 20065870 ⤷  Free Forever Trial
European Patent Office 1559710 ⤷  Free Forever Trial
Canada 2402894 ⤷  Free Forever Trial
Canada 2568391 ⤷  Free Forever Trial
China 1213028 ⤷  Free Forever Trial
Taiwan 200624420 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for SAXAGLIPTIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 SPC005/2010 Ireland ⤷  Free Forever Trial SPC005/2010: 20100702, EXPIRES: 20240930
1261586 C01261586/02 Switzerland ⤷  Free Forever Trial PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
2139494 C202030045 Spain ⤷  Free Forever Trial PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
2498758 122020000018 Germany ⤷  Free Forever Trial PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1261586 10C0010 France ⤷  Free Forever Trial PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE CHLORHYDRATE DE SAXAGLIPTINE; NAT. REGISTRATION NO/DATE: EU/1/09/545/001 20091001; FIRST REGISTRATION: EU/1/09/454/001 20091001
1261586 2010C/008 Belgium ⤷  Free Forever Trial PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1261586 15/2012 Austria ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Medtronic
AstraZeneca
Moodys
Johnson and Johnson

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