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 thirteen patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and seventy-two patent family members in forty-seven 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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Questions you can ask:
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Summary for SYNJARDY
International Patents: | 372 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
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 |
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 twelve US patents and two FDA Regulatory Exclusivities.
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 | 208658-002 | Dec 9, 2016 | RX | Yes | No | 11,833,166 | ⤷ Try for Free | ⤷ Try for Free | ||||
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | 11,833,166 | ⤷ Try for Free | ⤷ Try for Free | ||||
Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-004 | Aug 26, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | 12,263,153 | ⤷ Try for Free | ⤷ Try for Free | ||||
>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
See the table below for patents covering SYNJARDY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2606650 | FORME CRISTALLINE DE 1-CHLORO-4-(.BETA.-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-(.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) | ⤷ Try for Free |
Japan | 5685550 | ⤷ Try for Free | |
Argentina | 087208 | FORMA CRISTALINA DE 1-CLORO-4-(b-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 | ⤷ Try for Free |
Finland | 2981255 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | 14C0074 | France | ⤷ Try for Free | PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
1730131 | PA2014035 | Lithuania | ⤷ Try for Free | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
1730131 | 62/2014 | Austria | ⤷ Try for Free | PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527 |
1730131 | C 2014 039 | Romania | ⤷ Try for Free | PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of SYNJARDY
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