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Last Updated: October 1, 2023

SYNJARDY Drug Patent Profile


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Which patents cover Synjardy, and what generic alternatives are available?

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-two patent family members in forty-four countries.

The generic ingredient in SYNJARDY 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

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

There have been thirteen 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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Paragraph IV (Patent) Challenges for SYNJARDY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNJARDY Tablets empagliflozin; metformin hydrochloride 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg 206111 4 2018-08-01

US Patents and Regulatory Information for SYNJARDY

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

Patents protecting SYNJARDY

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting SYNJARDY

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity 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
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 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

International Patents for SYNJARDY

When does loss-of-exclusivity occur for SYNJARDY?

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

Argentina

Patent: 8041
Estimated Expiration: ⤷  Try a Trial

Patent: 1845
Estimated Expiration: ⤷  Try a Trial

Patent: 7512
Estimated Expiration: ⤷  Try a Trial

Patent: 7513
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05225511
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 7938
Estimated Expiration: ⤷  Try a Trial

Patent: 7013
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0508830
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 57801
Estimated Expiration: ⤷  Try a Trial

Patent: 87639
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 10000775
Estimated Expiration: ⤷  Try a Trial

China

Patent: 30141
Estimated Expiration: ⤷  Try a Trial

Patent: 3030617
Estimated Expiration: ⤷  Try a Trial

Patent: 3435581
Estimated Expiration: ⤷  Try a Trial

Patent: 3450129
Estimated Expiration: ⤷  Try a Trial

Patent: 3467423
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120627
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12948
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 30131
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066855
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1158
Estimated Expiration: ⤷  Try a Trial

Patent: 0601584
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 30131
Estimated Expiration: ⤷  Try a Trial

Patent: 28216
Estimated Expiration: ⤷  Try a Trial

Patent: 95422
Estimated Expiration: ⤷  Try a Trial

Patent: 60164
Estimated Expiration: ⤷  Try a Trial

Patent: 60165
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2004012676
Estimated Expiration: ⤷  Try a Trial

Patent: 2004040168
Estimated Expiration: ⤷  Try a Trial

Patent: 2004061145
Estimated Expiration: ⤷  Try a Trial

Patent: 2005009745
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 88775
Estimated Expiration: ⤷  Try a Trial

Patent: 88776
Estimated Expiration: ⤷  Try a Trial

Patent: 88777
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 400056
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7043
Estimated Expiration: ⤷  Try a Trial

Patent: 8714
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 81605
Estimated Expiration: ⤷  Try a Trial

Patent: 47314
Estimated Expiration: ⤷  Try a Trial

Patent: 47469
Estimated Expiration: ⤷  Try a Trial

Patent: 07246544
Estimated Expiration: ⤷  Try a Trial

Patent: 07522143
Estimated Expiration: ⤷  Try a Trial

Patent: 08208127
Estimated Expiration: ⤷  Try a Trial

Patent: 08524162
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 555
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1336
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 422
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0464
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 5264
Estimated Expiration: ⤷  Try a Trial

Patent: 14028
Estimated Expiration: ⤷  Try a Trial

Patent: 064201
Estimated Expiration: ⤷  Try a Trial

Patent: 140127
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060120
Estimated Expiration: ⤷  Try a Trial

Patent: 091588
Estimated Expiration: ⤷  Try a Trial

Patent: 091589
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 30131
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 30131
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 365
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 1271
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 30131
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0605511
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1174726
Estimated Expiration: ⤷  Try a Trial

Patent: 060133021
Estimated Expiration: ⤷  Try a Trial

Patent: 120007088
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 14743
Estimated Expiration: ⤷  Try a Trial

Patent: 87881
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 23264
Estimated Expiration: ⤷  Try a Trial

Patent: 0538463
Estimated Expiration: ⤷  Try a Trial

Patent: 0635599
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 040
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 807
Estimated Expiration: ⤷  Try a Trial

Patent: 817
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 SYNJARDY around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006064033 ⤷  Try a Trial
Mexico 2007013144 FORMA CRISTALINA DE 1-CLORO-4-((-D-GLUCOPIRANOS-1-IL)-2-[4-((S)- TETRAHIDROFURAN-3-ILOXI)-BENCIL]-BENCENO, UN METODO PARA SU PREPARACION Y EL USO DEL MISMO PARA PREPARAR MEDICAMENTOS. (CRYSTALLINE FORM OF 1-CHLORO-4-(????-D-GLUCOPYRANOS-1-YL)-2-[4-((S) -TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS.) ⤷  Try a Trial
Spain 2337498 ⤷  Try a Trial
European Patent Office 1888552 FORME CRISTALLINE DE 1-CHLORO-4-(ß-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, SON PROCEDE DE PREPARATION ET SON UTILISATION DANS LA PREPARATION DE MEDICAMENTS (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) ⤷  Try a Trial
Austria 452883 ⤷  Try a Trial
China 105263485 Therapeutic uses of empagliflozin ⤷  Try a Trial
Israel 218714 GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYNJARDY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C300696 Netherlands ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131 14C0074 France ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131 2014/055 Ireland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 122014000099 Germany ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 1490061-7 Sweden ⤷  Try a Trial PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1730131 PA2014035,C1730131 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 C01730131/04 Switzerland ⤷  Try a Trial 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
McKinsey
Dow
McKesson
Johnson and Johnson

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.