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 ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and thirty-four patent family members in forty-five 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: | 234 |
US Patents: | 8 |
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 |
---|---|
Hikma Pharma | Phase 1 |
Genuine Research Center, Egypt | 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 nine US patents and two FDA Regulatory Exclusivities.
Patents protecting SYNJARDY
Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
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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>=45 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 IS >=30 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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FDA Regulatory Exclusivity protecting SYNJARDY
NEW PATIENT POPULATION
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PEDIATRIC EXCLUSIVITY
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International Patents for SYNJARDY
See the table below for patents covering SYNJARDY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2005225511 | Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof | ⤷ Sign Up |
Japan | 2008208127 | GLUOCOPYRANOSYL-SUBSTITUTED PHENYL DERIVATIVE, MEDICAMENT CONTAINING THE COMPOUND, ITS USE AND PROCESS FOR PRODUCING THE SAME | ⤷ Sign Up |
New Zealand | 550464 | Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof | ⤷ Sign Up |
Germany | 602006011310 | ⤷ Sign Up | |
China | 101155794 | 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 |
China | 103435581 | Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof | ⤷ Sign Up |
Japan | 2008524162 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | C01730131/04 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021 |
1730131 | C20140033 00134 | Estonia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014 |
1730131 | 1490061-7 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
1730131 | 2014/055 | Ireland | ⤷ Sign Up | 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 | C01730131/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014 |
1730131 | C 2014 039 | Romania | ⤷ Sign Up | 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 |
1730131 | SPC/GB14/070 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF; REGISTERED: UK EU/1/14/930/001 - 20140527; UK EU/1/14/930/018 20140527 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |