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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Novartis
Fuji
Queensland Health
Chinese Patent Office
Deloitte
McKinsey
McKesson
Harvard Business School
Cantor Fitzgerald

Generated: February 24, 2018

DrugPatentWatch Database Preview

XIGDUO XR Drug Profile

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When do Xigduo Xr patents expire, and when can generic versions of Xigduo Xr launch?

Xigduo Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and twenty-three patent family members in forty-four countries.

The generic ingredient in XIGDUO XR is dapagliflozin propanediol; metformin hydrochloride. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin propanediol; metformin hydrochloride profile page.
Summary for XIGDUO XR
International Patents:223
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 3
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XIGDUO XR at DailyMed
Drug patent expirations by year for XIGDUO XR
Pharmacology for XIGDUO XR

US Patents and Regulatory Information for XIGDUO XR

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 propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; 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 propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; 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 propanediol; 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 propanediol; 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 propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y 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 XIGDUO XR

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
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Try a Free Trial
8,221,786 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Try a Free Trial
8,361,972 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Try a Free Trial
8,535,715 Bilayer tablet formulations ➤ Try a Free Trial
9,050,258 Bilayer tablet formulations ➤ Try a Free Trial
8,716,251 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Try a Free Trial
7,851,502 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for XIGDUO XR

Supplementary Protection Certificates for XIGDUO XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014026 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0022 France ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
13/013 Ireland ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
2014000071 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
6 5005-2013 Slovakia ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
2013008 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2014000070 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2013008,C1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2013 00019 Denmark ➤ Try a Free Trial
0140021 00131 Estonia ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Merck
Fuji
Daiichi Sankyo
QuintilesIMS
Fish and Richardson
Teva
Deloitte
Accenture

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.

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