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Last Updated: July 22, 2024

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SYNJARDY XR Drug Patent Profile


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Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?

Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and nine patent family members in forty-one countries.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Synjardy Xr

Synjardy Xr was eligible for patent challenges on August 1, 2018.

There have been fourteen 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.

Indicators of Generic Entry

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Drug patent expirations by year for SYNJARDY XR
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Recent Clinical Trials for SYNJARDY XR

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

SponsorPhase
Hikma PharmaPhase 1
Genuine Research Center, EgyptPhase 1

See all SYNJARDY XR clinical trials

Pharmacology for SYNJARDY XR
Paragraph IV (Patent) Challenges for SYNJARDY XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNJARDY XR Extended-release Tablets empagliflozin; metformin hydrochloride 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg 208658 3 2018-08-01

US Patents and Regulatory Information for SYNJARDY XR

SYNJARDY XR is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting SYNJARDY XR

Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical compositions
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Pharmaceutical composition, methods for treating and uses thereof
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Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN


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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND


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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
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Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
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Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, methods for treating and uses thereof
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FDA Regulatory Exclusivity protecting SYNJARDY XR

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
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PEDIATRIC EXCLUSIVITY
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 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 SYNJARDY XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SYNJARDY XR

See the table below for patents covering SYNJARDY XR around the world.

Country Patent Number Title Estimated Expiration
Montenegro 01173 KRISTALNI OBLIK 1-HLORO-4-(β-D-GLUKOPIRANOZ-1-YL)-2-[4-((S)-TETRAHIDROFURAN-3- ILOKSI)-BENZIL]-BENZOLA, POSTUPAK ZA NJEGOVO DOBIJANJE I NJEGOVA PRIMJENA ZA DOBIJANJE LJEKOVA (CRYSTALLINE FORM OF 1-CHLORO-4-(ß-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS) ⤷  Sign Up
Japan 6325084 ⤷  Sign Up
Cyprus 1109870 ⤷  Sign Up
Portugal 1294363 ⤷  Sign Up
Austria E407938 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYNJARDY XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/02 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131 C01730131/03 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131 14C0074 France ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131 CA 2014 00054 Denmark ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131 C01730131/04 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
>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.