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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
UBS
Johnson and Johnson
Cipla
Moodys
Chinese Patent Office
Queensland Health
Accenture
QuintilesIMS

Generated: July 17, 2018

DrugPatentWatch Database Preview

SYNJARDY XR Drug 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 four patents protecting this drug.

This drug has one hundred and forty-three patent family members in thirty-six countries.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are fourteen 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.
Drug patent expirations by year for SYNJARDY XR
Generic Entry Opportunity Date for SYNJARDY XR
Generic Entry Date for SYNJARDY XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SYNJARDY XR

US Patents and Regulatory Information for SYNJARDY XR

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 208658-001 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 208658-002 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

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Non-Orange Book US Patents for SYNJARDY XR

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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Supplementary Protection Certificates for SYNJARDY XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00696 Netherlands ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
14/055 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
C0074 France ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140522
2014 00054 Denmark ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Johnson and Johnson
AstraZeneca
Fuji
Farmers Insurance
Chubb
Citi
Fish and Richardson
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.