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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
McKinsey
Fuji
Citi
Federal Trade Commission
Merck
Harvard Business School
McKesson

Generated: May 25, 2018

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 dapagliflozin; metformin hydrochloride patent protection?

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

Dapagliflozin; metformin hydrochloride has two hundred and twenty-three patent family members in forty-four countries.

There are twenty drug master file entries for dapagliflozin; metformin hydrochloride. One supplier is listed for this compound.
Summary for dapagliflozin; metformin hydrochloride
International Patents:223
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 20
Suppliers / Packagers: 1
Clinical Trials: 1,925
DailyMed Link:dapagliflozin; metformin hydrochloride at DailyMed
Pharmacology for dapagliflozin; metformin hydrochloride

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 XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for dapagliflozin; metformin hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,535,715 Bilayer tablet formulations ➤ Try a Free Trial
8,221,786 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Try a Free Trial
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Try a Free Trial
8,716,251 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00677 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
182 Luxembourg ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2014026 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2013000033 Germany ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Covington
Healthtrust
Boehringer Ingelheim
Mallinckrodt
Deloitte
McKesson
Chinese Patent Office
Citi

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.