Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
AstraZeneca
Boehringer Ingelheim
Moodys
Johnson and Johnson

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Dapagliflozin; metformin hydrochloride - Generic Drug Details

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

Dapagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride has two hundred and forty-six patent family members in forty-five countries.

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

Summary for dapagliflozin; metformin hydrochloride
International Patents:246
US Patents:11
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 26
Suppliers / Packagers: 1
Clinical Trials: 76
DailyMed Link:dapagliflozin; metformin hydrochloride at DailyMed
Recent Clinical Trials for dapagliflozin; metformin hydrochloride

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SponsorPhase
The Swedish National Diabetes RegisterPhase 4
Swedish Healthcare RegionsPhase 4
Uppsala University HospitalPhase 4

See all dapagliflozin; metformin hydrochloride clinical trials

Pharmacology for dapagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
XIGDUO XR TABLET, EXTENDED RELEASE;ORAL dapagliflozin; metformin hydrochloride 205649 2018-10-29
XIGDUO XR TABLET, EXTENDED RELEASE;ORAL dapagliflozin; metformin hydrochloride 205649 2018-01-08

US Patents and Regulatory Information for dapagliflozin; metformin 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 210874-004 May 2, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   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 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 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   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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C 2014 029 Romania   Start Trial PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211 C01506211/02 Switzerland   Start Trial PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
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
1506211 18/2013 Austria   Start Trial PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKesson
Baxter
Medtronic
Harvard Business School

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.