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Serving leading biopharmaceutical companies globally:

UBS
Julphar
McKinsey
Medtronic
Baxter
McKesson
Argus Health
Healthtrust
Mallinckrodt
Queensland Health

Generated: October 16, 2017

DrugPatentWatch Database Preview

SYNJARDY Drug Profile

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What is the patent landscape for Synjardy, 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 and fourteen supplementary protection certificates in twelve countries.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are five 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 Tradename: SYNJARDY

US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SYNJARDY at DailyMed

Pharmacology for Tradename: 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;ORAL208658-004Dec 9, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-002Dec 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-001Dec 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-002Dec 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-001Dec 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-002Aug 26, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-004Aug 26, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-003Aug 26, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-003Dec 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-001Aug 26, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: 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
7,687,469Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: SYNJARDY

Country Document Number Estimated Expiration
Norway20140127► Subscribe
Taiwan200716586► Subscribe
Peru15892009► Subscribe
BrazilPI0610994► Subscribe
Portugal1888552► Subscribe
Norway2014028► Subscribe
Serbia52365► Subscribe
Eurasian Patent Organization200601584► Subscribe
Spain2314743► Subscribe
South Africa200705883► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SYNJARDY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131/02Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
555Luxembourg► SubscribePRODUCT 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
/2014Austria► SubscribePRODUCT 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
2014 00054Denmark► SubscribePRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131/01Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
0140033 00134Estonia► SubscribePRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
2014035,C1730131Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
14/055Ireland► SubscribePRODUCT 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
2014035Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2014000099Germany► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
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Serving leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Covington
Citi
Queensland Health
Merck
Medtronic
McKinsey
QuintilesIMS
Chubb

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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