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Empagliflozin; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for empagliflozin; metformin hydrochloride?

Empagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has one hundred and seventeen patent family members in thirty-three countries.

There are three drug master file entries for empagliflozin; metformin hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: empagliflozin; metformin hydrochloride

Tradenames:2
Patents:4
Applicants:1
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Clinical Trials: see list1,697
Drug Prices:see low prices
DailyMed Link:empagliflozin; metformin hydrochloride at DailyMed

Pharmacology for Ingredient: empagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-003Aug 26, 2015RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-004Aug 26, 2015RXYesYes7,713,938► SubscribeYY ► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-003Dec 9, 2016RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-001Aug 26, 2015RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-002Dec 9, 2016RXYesNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: empagliflozin; metformin hydrochloride

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 Ingredient: empagliflozin; metformin hydrochloride

Country Document Number Estimated Expiration
Japan4226070► Subscribe
Israel187087► Subscribe
Mexico2007013144► Subscribe
BrazilPI0610994► Subscribe
Japan4181605► 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: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00696Netherlands► SubscribePRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
2014 00054Denmark► SubscribePRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
C0074France► SubscribePRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140522
0 5026-2014Slovakia► SubscribePRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
/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
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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 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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