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Last Updated: June 18, 2021

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XIGDUO XR Drug Profile


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Which patents cover 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 five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-eight patent family members in forty-six countries.

The generic ingredient in XIGDUO XR is dapagliflozin; metformin hydrochloride. There are twenty-six 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.

DrugPatentWatch® Generic Entry Outlook for Xigduo Xr

Xigduo Xr was eligible for patent challenges on January 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2030. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (dapagliflozin; metformin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for XIGDUO XR
Drug Prices for XIGDUO XR

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for XIGDUO XR
Generic Entry Date for XIGDUO XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XIGDUO XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of GuadalajaraPhase 4
AstraZenecaPhase 1
ParexelPhase 1

See all XIGDUO XR clinical trials

Paragraph IV (Patent) Challenges for XIGDUO XR
Tradename Dosage Ingredient NDA Submissiondate
XIGDUO XR TABLET, EXTENDED RELEASE;ORAL dapagliflozin; metformin hydrochloride 205649 2018-10-29
XIGDUO XR TABLET, EXTENDED RELEASE;ORAL dapagliflozin; metformin hydrochloride 205649 2018-01-08

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   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for XIGDUO XR

International Patents for XIGDUO XR

Country Patent Number Estimated Expiration
Hungary E048897   Try Before You Buy
Japan 2005531588   Try Before You Buy
Croatia P20141007   Try Before You Buy
Eurasian Patent Organization 200901277   Try Before You Buy
World Intellectual Property Organization (WIPO) 2008116179   Try Before You Buy
Spain 2769130   Try Before You Buy
Germany 60311649   Try Before You Buy
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for XIGDUO XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 588 Finland   Try Before You Buy
1506211 PA2014026,C1506211 Lithuania   Try Before You Buy PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494 2020C/533 Belgium   Try Before You Buy PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1506211 CA 2013 00019 Denmark   Try Before You Buy
1506211 122013000033 Germany   Try Before You Buy PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211 SPC/GB14/050 United Kingdom   Try Before You Buy PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1506211 42/2014 Austria   Try Before You Buy PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Baxter
McKinsey
Dow
AstraZeneca

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 verification 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.