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Last Updated: November 24, 2024

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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-six 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 May 12, 2031. This may change due to patent challenges or generic licensing.

There have been seven 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 and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Bilayer tablet formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting XIGDUO XR

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 205649-004 Oct 29, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 ⤷  Sign Up ⤷  Sign Up
>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
Patent: Bilayer tablet formulations
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012011726
Patent: comprimidos de duas camadas, seu uso, e suas combinações farmacêuticas
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 80939
Patent: FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 87757
Patent: FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2711739
Patent: Bilayer tablet formulations
Estimated Expiration: ⤷  Sign Up

Patent: 5193761
Patent: BILAYER TABLET FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0181347
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 98758
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 98758
Patent: FORMULATIONS DE COMPRIMÉ BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 15124
Patent: FORMULATIONS DE COMPRIMÉS BICOUCHES (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 40486
Estimated Expiration: ⤷  Sign Up

Patent: 000009
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 75522
Estimated Expiration: ⤷  Sign Up

Patent: 67299
Estimated Expiration: ⤷  Sign Up

Patent: 22862
Estimated Expiration: ⤷  Sign Up

Patent: 13510873
Estimated Expiration: ⤷  Sign Up

Patent: 15110630
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 17081943
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 18172418
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 498758
Estimated Expiration: ⤷  Sign Up

Patent: 2020003
Estimated Expiration: ⤷  Sign Up

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 5777
Patent: FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Patent: 12005416
Patent: FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 20009
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 83920
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (BI-LAYER TABLET COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 12757
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (DOUBLE-LAYER TABLET COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 12123947
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ
Estimated Expiration: ⤷  Sign Up

Patent: 16112599
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 756
Patent: FORMULACIJE TABLETA SA DVA SLOJA (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 89107
Estimated Expiration: ⤷  Sign Up

Patent: 56888
Estimated Expiration: ⤷  Sign Up

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
Eurasian Patent Organization 020288 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ПРОПИЛЕНГЛИКОЛЬ-ГИДРАТ ДАПАГЛИФЛОЗИНА (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) ⤷  Sign Up
Portugal 1506211 ⤷  Sign Up
Canada 2987757 FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS) ⤷  Sign Up
Brazil 112012011726 comprimidos de duas camadas, seu uso, e suas combinações farmacêuticas ⤷  Sign Up
South Korea 20090023643 CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XIGDUO XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 588 Finland ⤷  Sign Up
2139494 SPC/GB20/028 United Kingdom ⤷  Sign Up PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719
1506211 C300677 Netherlands ⤷  Sign Up 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
1506211 PA2014026,C1506211 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494 PA2020522 Lithuania ⤷  Sign Up PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.