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Last Updated: February 26, 2024

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-five 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. Two suppliers are 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 Loss of Exclusivity (LOE) 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
Beni-Suef UniversityPhase 3
University of GuadalajaraPhase 4
AstraZenecaPhase 1

See all XIGDUO XR clinical trials

Pharmacology for XIGDUO XR
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XIGDUO XR is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 205649-005 Jul 28, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: ⤷  Try a Trial

Brazil

Patent: 2012011726
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 80939
Estimated Expiration: ⤷  Try a Trial

Patent: 87757
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2711739
Estimated Expiration: ⤷  Try a Trial

Patent: 5193761
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0181347
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 98758
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 98758
Estimated Expiration: ⤷  Try a Trial

Patent: 15124
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 40486
Estimated Expiration: ⤷  Try a Trial

Patent: 000009
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 75522
Estimated Expiration: ⤷  Try a Trial

Patent: 67299
Estimated Expiration: ⤷  Try a Trial

Patent: 22862
Estimated Expiration: ⤷  Try a Trial

Patent: 13510873
Estimated Expiration: ⤷  Try a Trial

Patent: 15110630
Estimated Expiration: ⤷  Try a Trial

Patent: 17081943
Estimated Expiration: ⤷  Try a Trial

Patent: 18172418
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 498758
Estimated Expiration: ⤷  Try a Trial

Patent: 2020003
Estimated Expiration: ⤷  Try a Trial

Patent: 98758
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 5777
Estimated Expiration: ⤷  Try a Trial

Patent: 12005416
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 20009
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 98758
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 98758
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 83920
Estimated Expiration: ⤷  Try a Trial

Patent: 12757
Estimated Expiration: ⤷  Try a Trial

Patent: 12123947
Estimated Expiration: ⤷  Try a Trial

Patent: 16112599
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 756
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 98758
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 89107
Estimated Expiration: ⤷  Try a Trial

Patent: 56888
Estimated Expiration: ⤷  Try a Trial

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
Norway 346828 ⤷  Try a Trial
European Patent Office 1506211 C-ARYL GLUCOSIDES EN TANT QU'INHIBITEURS DE SGLT-2 ET METHODE CORRESPONDANTE (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) ⤷  Try a Trial
Norway 323698 ⤷  Try a Trial
Mexico 249731 C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO. (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XIGDUO XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 PA2020522 Lithuania ⤷  Try a Trial PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
2139494 122020000043 Germany ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211 C20130006 00074 Estonia ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211 C01506211/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
>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.