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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Cipla
Teva
Covington
QuintilesIMS
Daiichi Sankyo
Mallinckrodt
Baxter
Federal Trade Commission

Generated: April 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 and one Paragraph IV challenge.

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

The generic ingredient in XIGDUO XR is dapagliflozin; 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; 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; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for XIGDUO XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 5 mg/500 mg5 mg/1000 mg10 mg/500 mg10 mg/1000 mg ➤ Subscribe 2018-01-08

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
8,535,715 Bilayer tablet formulations ➤ Sign Up
7,851,502 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Sign Up
8,221,786 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Sign Up
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for XIGDUO XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000071 Germany ➤ Sign Up 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
C0022 France ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
2013 008, C 1506211 Lithuania ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2013008,C1506211 Lithuania ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chubb
AstraZeneca
Citi
US Army
Farmers Insurance
Teva
Healthtrust
McKinsey

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