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 |
---|---|
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 nine 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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
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
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Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition, methods for treating and uses thereof
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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
See the table below for patents covering SYNJARDY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 048041 | DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, COMPOSICIONES FARMACEUTICAS Y PROCEDIMIENTO PARA SU PREPARACION | ⤷ Try a Trial |
Poland | 2482806 | ⤷ Try a Trial | |
Serbia | 58097 | TERAPEUTSKE PRIMENE EMPAGLIFLOZINA (THERAPEUTIC USES OF EMPAGLIFLOZIN) | ⤷ Try a Trial |
China | 109893534 | 依帕列净的治疗用途 (Therapeutic uses of empagliflozin) | ⤷ Try a Trial |
Denmark | 2981255 | ⤷ Try a Trial | |
Japan | 2007246544 | GLUCOPYRANOSYL-SUBSTITUTED PHENYL DERIVATIVE, MEDICINE CONTAINING THE COMPOUND, ITS USE AND METHOD FOR PRODUCING THE SAME | ⤷ 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 | PA2014035,C1730131 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
1730131 | CA 2014 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522 |
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 | CR 2014 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527 |
1730131 | C20140033 00134 | Estonia | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014 |
1730131 | C01730131/05 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |