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
Summary for SYNJARDY
International Patents: | 222 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
Patent Applications: | 5 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SYNJARDY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY |
What excipients (inactive ingredients) are in SYNJARDY? | SYNJARDY excipients list |
DailyMed Link: | SYNJARDY at DailyMed |


Recent Clinical Trials for SYNJARDY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Genuine Research Center, Egypt | Phase 1 |
Hikma Pharma | Phase 1 |
Pharmacology for SYNJARDY
Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SYNJARDY
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
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 |