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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Merck
Chinese Patent Office
Accenture
Dow
Cantor Fitzgerald
AstraZeneca
Boehringer Ingelheim
Fuji

Generated: November 23, 2017

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Empagliflozin - Generic Drug Details

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What are the generic sources for empagliflozin and what is the scope of empagliflozin patent protection?

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

Empagliflozin has one hundred and fifty-six patent family members in forty countries and eighteen supplementary protection certificates in twelve countries.

There are five drug master file entries for empagliflozin. Two suppliers are listed for this compound.

Pharmacology for empagliflozin

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;ORAL208658-002Dec 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-003Dec 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-001Dec 9, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JARDIANCE
empagliflozin
TABLET;ORAL204629-002Aug 1, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
SYNJARDY
empagliflozin; metformin hydrochloride
TABLET;ORAL206111-004Aug 26, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
SYNJARDY XR
empagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208658-001Dec 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-002Jan 30, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL206073-001Jan 30, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: empagliflozin

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

Country Document Number Estimated Expiration
South Africa200605511► Subscribe
Israel187087► Subscribe
Taiwan200635599► Subscribe
South Korea20080015424► Subscribe
Denmark2187879► Subscribe
Peru13742006► Subscribe
EcuadorSP066855► Subscribe
Poland2187879► Subscribe
European Patent Office2360164► Subscribe
TaiwanI323264► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1730131/02Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131/01Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
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
2017000024Germany► SubscribePRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2017014Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
2014035,C1730131Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2017 00019Denmark► SubscribePRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
90061-7Sweden► SubscribePRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522
00696Netherlands► SubscribePRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
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Serving leading biopharmaceutical companies globally:

Moodys
US Army
Cerilliant
Cantor Fitzgerald
Julphar
McKinsey
Medtronic
Novartis
Johnson and Johnson
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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