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Last Updated: August 9, 2020

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Dapagliflozin; saxagliptin hydrochloride - Generic Drug Details

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What are the generic sources for dapagliflozin; saxagliptin hydrochloride and what is the scope of patent protection?

Dapagliflozin; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; saxagliptin hydrochloride has three hundred and forty-nine patent family members in forty-seven countries.

There are twenty-six drug master file entries for dapagliflozin; saxagliptin hydrochloride. One supplier is listed for this compound.

Summary for dapagliflozin; saxagliptin hydrochloride
International Patents:349
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 26
Suppliers / Packagers: 1
Clinical Trials: 25
DailyMed Link:dapagliflozin; saxagliptin hydrochloride at DailyMed
Recent Clinical Trials for dapagliflozin; saxagliptin hydrochloride

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

SponsorPhase
Sabyasachi SenPhase 4
Third Affiliated Hospital, Sun Yat-Sen UniversityPhase 4
Peking University Shenzhen HospitalPhase 4

See all dapagliflozin; saxagliptin hydrochloride clinical trials

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
QTERN TABLET;ORAL dapagliflozin; saxagliptin hydrochloride 209091 2018-01-08

US Patents and Regulatory Information for dapagliflozin; 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 QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 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 dapagliflozin; saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 CA 2012 00014 Denmark   Start Trial
1506211 PA2013008 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211 C20130006 00074 Estonia   Start Trial PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211 179 5017-2014 Slovakia   Start Trial PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1261586 10C0010 France   Start 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
1506211 132014902277722 Italy   Start Trial PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
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McKinsey

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