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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.
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
Summary for XIGDUO XR
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||1|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for XIGDUO XR|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for XIGDUO XR|
|DailyMed Link:||XIGDUO XR at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XIGDUO XR
*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
|University of Guadalajara||Phase 4|
Pharmacology for XIGDUO XR
ATC Classes 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|
|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|