synjardy Drug Patent Profile
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When do Synjardy patents expire, 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-five 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
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Summary for synjardy
International Patents: | 235 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
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 |
![synjardy drug patent expirations Drug patent expirations by year for synjardy](/p/graph/s/t/synjardy-patent-expirations.png)
![Drug Prices for synjardy](/p/graph/drug-price/synjardy.png)
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 |
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
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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 |
---|---|---|---|
European Patent Office | 1828216 | DERIVES DE BENZENE SUBSTITUES PAR GLUCOPYRANOSYLE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE) | ⤷ Sign Up |
South Korea | 20210131442 | 엠파글리플로진의 치료적 용도 (THERAPEUTIC USES OF EMPAGLIFLOZIN) | ⤷ Sign Up |
Japan | 2016515600 | エンパグリフロジンの治療的使用 | ⤷ Sign Up |
Denmark | 1730131 | ⤷ Sign Up | |
Denmark | 2482806 | ⤷ Sign Up | |
European Patent Office | 2360164 | Derives de benzene substitues par glucopyranosyle, medicaments renfermant ces composes, leur utilisation et leur procede de fabrication (Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof) | ⤷ Sign Up |
Portugal | 1730131 | ⤷ 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 | C01730131/05 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022 |
1730131 | 200 5026-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
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 | PA2014035 | Lithuania | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
1730131 | C300696 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522 |
1730131 | CR 2014 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527 |
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 |