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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Colorcon
US Army
Queensland Health
Chubb
Boehringer Ingelheim
Covington
QuintilesIMS
Harvard Business School

Generated: December 12, 2017

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 nineteen patent family members in forty-four countries and twenty-seven 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.
Drug patent expirations by year for XIGDUO XR

Pharmacology for XIGDUO XR

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-005Jul 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-002Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-001Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe► 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
8,535,715Bilayer tablet formulations► Subscribe
9,453,039Crystal structures of SGLT2 inhibitors and processes for preparing same► Subscribe
9,050,258Bilayer tablet formulations► Subscribe
8,716,251Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
8,221,786Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
8,361,972Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
7,851,502Pharmaceutical formulations containing an SGLT2 inhibitor► 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
European Patent Office2508188► Subscribe
Hungary229446► Subscribe
Poland355018► Subscribe
Mexico2008015377► Subscribe
China105193761► Subscribe
Israel245688► Subscribe
Russian Federation2337916► Subscribe
Israel195882► Subscribe
China1407990► Subscribe
Japan2010522244► 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
13/013Ireland► SubscribePRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
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
6 5005-2013Slovakia► SubscribePRODUCT 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
1506211/02Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
2013000033Germany► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
00677Netherlands► SubscribePRODUCT 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
0140021 00131Estonia► SubscribePRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
/2013Austria► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
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Serving leading biopharmaceutical companies globally:

UBS
McKesson
Colorcon
Cantor Fitzgerald
Farmers Insurance
US Department of Justice
Healthtrust
Fuji
Novartis
Cipla

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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