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Serving leading biopharmaceutical companies globally:

Healthtrust
Teva
Cantor Fitzgerald
US Department of Justice
Federal Trade Commission
Citi
Express Scripts
UBS
Mallinckrodt
Cipla

Generated: February 23, 2018

DrugPatentWatch Database Preview

SYNJARDY Drug Profile

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When do Synjardy patents expire, and when can generic versions of Synjardy launch?

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are three patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-four countries.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are eight 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.
Summary for SYNJARDY
International Patents:108
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SYNJARDY at DailyMed
Drug patent expirations by year for SYNJARDY
Pharmacology for SYNJARDY

US Patents and Regulatory Information for SYNJARDY

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 Y ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y 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
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No ➤ 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 ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for SYNJARDY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,687,469 Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for SYNJARDY

Supplementary Protection Certificates for SYNJARDY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00054 Denmark ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
2014035 Lithuania ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
0140033 00134 Estonia ➤ Sign Up PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
/2014 Austria ➤ Sign Up 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
1730131/02 Switzerland ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
0 5026-2014 Slovakia ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
2014000099 Germany ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131/01 Switzerland ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
555 Luxembourg ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
90061-7 Sweden ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Julphar
Teva
US Department of Justice
Cipla
Covington
AstraZeneca
Dow

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 verifification 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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