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Boehringer Ingelheim
Mallinckrodt

Last Updated: November 13, 2019

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Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details

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What are the generic drug sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?

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

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

There are twenty-six drug master file entries for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride.

Summary for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
Recent Clinical Trials for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

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SponsorPhase
Sabyasachi SenPhase 4
Peking University Shenzhen HospitalPhase 4
The First Affiliated Hospital of Guangdong Pharmaceutical UniversityPhase 4

See all dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride clinical trials

Recent Litigation for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc.2018-05-01
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2018-01-09
MITSUBISHI TANABE PHARMA CORPORATION v. AUROBINDO PHARMA USA, INC.2017-07-07

See all dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride litigation

PTAB Litigation
PetitionerDate
Aurobindo Pharma U.S.A., Inc.2016-06-02
Amneal Pharmaceuticals LLC2016-06-01
Teva Pharmaceuticals USA Inc.2016-06-01

See all dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride litigation

US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride; 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 QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 RX Yes No   Start Trial   Start Trial   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; metformin hydrochloride; saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 91985 Luxembourg   Start Trial 91985, EXPIRES: 20260305
1261586 379 Finland   Start Trial
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 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
1506211 1390017-0 Sweden   Start Trial PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Harvard Business School
Dow
Colorcon
Express Scripts

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.