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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
McKesson
McKinsey
Cerilliant
Merck
Healthtrust
Novartis
Express Scripts
QuintilesIMS

Generated: October 22, 2017

DrugPatentWatch Database Preview

XIGDUO XR Drug Profile

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What is the patent landscape for Xigduo Xr, 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 seventeen patent family members in forty-four countries and twenty-six supplementary protection certificates in twelve countries.

The generic ingredient in XIGDUO XR is dapagliflozin propanediol; metformin hydrochloride. There are sixteen 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 Tradename: XIGDUO XR

US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list3
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XIGDUO XR at DailyMed

Pharmacology for Tradename: 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;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-005Jul 28, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-002Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-001Oct 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: 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
8,361,972Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
9,453,039Crystal structures of SGLT2 inhibitors and processes for preparing same► Subscribe
9,050,258Bilayer tablet formulations► Subscribe
7,851,502Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
8,221,786Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
8,716,251Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
8,535,715Bilayer tablet formulations► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: XIGDUO XR

Country Document Number Estimated Expiration
South Korea20140069365► Subscribe
Cyprus1115738► Subscribe
Hong Kong1127359► Subscribe
Taiwan201509927► Subscribe
Israel245688► Subscribe
World Intellectual Property Organization (WIPO)2008116179► Subscribe
Germany60020259► Subscribe
CroatiaP20141007► Subscribe
New Zealand518029► Subscribe
China102711739► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: XIGDUO XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90017-0Sweden► SubscribePRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
182Luxembourg► SubscribePRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2014000071Germany► SubscribePRODUCT 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
C0022France► SubscribePRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
1506211/01Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2013008Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2013008,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
9 5017-2014Slovakia► SubscribePRODUCT 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
13/013Ireland► SubscribePRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
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Serving leading biopharmaceutical companies globally:

Fuji
Accenture
Moodys
Chubb
Healthtrust
Baxter
QuintilesIMS
Fish and Richardson
Novartis
Deloitte

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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