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Last Updated: September 25, 2022

XIGDUO XR Drug Patent 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 thirty-three 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

See drug prices for XIGDUO XR

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
ParexelPhase 1
AstraZenecaPhase 1

See all XIGDUO XR clinical trials

Paragraph IV (Patent) Challenges for XIGDUO XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XIGDUO XR Extended-release Tablets dapagliflozin; metformin hydrochloride 2.5 mg/1000 mg 205649 1 2018-10-29
XIGDUO XR Extended-release Tablets dapagliflozin; metformin hydrochloride 5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg 205649 10 2018-01-08

US Patents and Regulatory Information for XIGDUO XR

XIGDUO XR is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XIGDUO XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XIGDUO XR

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE

Bilayer tablet formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XIGDUO XR

TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

When does loss-of-exclusivity occur for XIGDUO XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10319343
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012011726
Estimated Expiration: See Plans and Pricing

Canada

Patent: 80939
Estimated Expiration: See Plans and Pricing

Patent: 87757
Estimated Expiration: See Plans and Pricing

China

Patent: 2711739
Estimated Expiration: See Plans and Pricing

Patent: 5193761
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181347
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 98758
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 98758
Estimated Expiration: See Plans and Pricing

Patent: 15124
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 40486
Estimated Expiration: See Plans and Pricing

Patent: 000009
Estimated Expiration: See Plans and Pricing

Japan

Patent: 75522
Estimated Expiration: See Plans and Pricing

Patent: 67299
Estimated Expiration: See Plans and Pricing

Patent: 22862
Estimated Expiration: See Plans and Pricing

Patent: 13510873
Estimated Expiration: See Plans and Pricing

Patent: 15110630
Estimated Expiration: See Plans and Pricing

Patent: 17081943
Estimated Expiration: See Plans and Pricing

Patent: 18172418
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 498758
Estimated Expiration: See Plans and Pricing

Patent: 2020003
Estimated Expiration: See Plans and Pricing

Patent: 98758
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5777
Estimated Expiration: See Plans and Pricing

Patent: 12005416
Estimated Expiration: See Plans and Pricing

Norway

Patent: 20009
Estimated Expiration: See Plans and Pricing

Poland

Patent: 98758
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 98758
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 83920
Estimated Expiration: See Plans and Pricing

Patent: 12757
Estimated Expiration: See Plans and Pricing

Patent: 12123947
Estimated Expiration: See Plans and Pricing

Patent: 16112599
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 756
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 98758
Estimated Expiration: See Plans and Pricing

Spain

Patent: 89107
Estimated Expiration: See Plans and Pricing

Patent: 56888
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XIGDUO XR around the world.

Country Patent Number Title Estimated Expiration
Ukraine 77306 С-АРИЛ ГЛЮКОЗИДНЫЕ ИНГИБИТОРЫ SGLT2 И СПОСОБ ИХ ПРИМЕНЕНИЯ;С-АРИЛ ГЛЮКОЗИДНІ SGLT2 ІНГІБІТОРИ ТА СПОСІБ ЇХ ЗАСТОСУВАННЯ (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD FOR THEIR USE) See Plans and Pricing
Japan 2005531588 See Plans and Pricing
Montenegro 00091 C-ARIL GLUKOZID SGLT2 INHIBITORI I POSTUPAK ZA NJIHOVU UPOTREBU (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) See Plans and Pricing
Portugal 1506211 See Plans and Pricing
South Korea 101493102 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011060256 See Plans and Pricing
South Korea 101021752 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XIGDUO XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 CR 2014 00037 Denmark See Plans and Pricing PRODUCT 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
1506211 300677 Netherlands See Plans and Pricing PRODUCT 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
2498758 CR 2020 00017 Denmark See Plans and Pricing PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
1506211 136 5005-2013 Slovakia See Plans and Pricing PRODUCT 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 SPC/GB14/050 United Kingdom See Plans and Pricing 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 C20130006 00074 Estonia See Plans and Pricing PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211 C 2014 029 Romania See Plans and Pricing PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Express Scripts
Baxter
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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.