SYNJARDY XR Drug Patent Profile
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Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?
Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and nine patent family members in forty-one countries.
The generic ingredient in SYNJARDY XR 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 Xr
Synjardy Xr was eligible for patent challenges on August 1, 2018.
There have been fourteen 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 XR
| International Patents: | 209 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Patent Applications: | 4 |
| Drug Prices: | Drug price information for SYNJARDY XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY XR |
| DailyMed Link: | SYNJARDY XR at DailyMed |
Recent Clinical Trials for SYNJARDY XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Genuine Research Center, Egypt | Phase 1 |
| Hikma Pharma | Phase 1 |
Pharmacology for SYNJARDY XR
| Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Paragraph IV (Patent) Challenges for SYNJARDY XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SYNJARDY XR | Extended-release Tablets | empagliflozin; metformin hydrochloride | 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg | 208658 | 3 | 2018-08-01 |
US Patents and Regulatory Information for SYNJARDY XR
SYNJARDY XR is protected by ten US patents and two FDA Regulatory Exclusivities.
Patents protecting SYNJARDY XR
Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical compositions
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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 IS >=30 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>=45 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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Pharmaceutical composition, methods for treating and uses thereof
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FDA Regulatory Exclusivity protecting SYNJARDY XR
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
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PEDIATRIC EXCLUSIVITY
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| 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 | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SYNJARDY XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SYNJARDY XR
See the table below for patents covering SYNJARDY XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2022069476 | エンパグリフロジンの治療的使用 | ⤷ Sign Up |
| Denmark | 1730131 | ⤷ Sign Up | |
| Montenegro | 01422 | DERIVATI BENZOLA SUPSTITUISANI GLUKOPIRANOZILOM, LJEKOVI KOJI SADRŽE NAVEDENA JEDINJENJA, NJIHOVA PRIMJENA I NJIHOV POSTUPAK PROIZVODNJE (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF) | ⤷ Sign Up |
| Australia | 3989301 | ⤷ Sign Up | |
| Japan | 2003535886 | ⤷ Sign Up | |
| Eurasian Patent Organization | 011158 | ЗАМЕЩЁННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩИЕ ЭТИ СОЕДИНЕНИЯ ЛЕКАРСТВЕННЫЕ СРЕДСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF) | ⤷ Sign Up |
| Cyprus | 1121203 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | 200 5026-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
| 1730131 | PA2014035,C1730131 | Lithuania | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | 1490061-7 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
| 1730131 | C20140033 00134 | Estonia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014 |
| 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 | C01730131/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017 |
| 1730131 | C01730131/05 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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