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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Daiichi Sankyo
Harvard Business School
Accenture
QuintilesIMS
Mallinckrodt
Express Scripts
Colorcon
Deloitte

Generated: December 12, 2017

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JARDIANCE Drug Profile

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Which patents cover Jardiance, and what generic alternatives are available?

Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in JARDIANCE is empagliflozin. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-002Aug 1, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-002Aug 1, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-001Aug 1, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJARDIANCEempagliflozinTABLET;ORAL204629-002Aug 1, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: JARDIANCE

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: JARDIANCE

Country Document Number Estimated Expiration
European Patent Office2698152► Subscribe
Norway20064201► Subscribe
Eurasian Patent Organization013079► Subscribe
Japan5595914► Subscribe
Hong Kong1203351► Subscribe
Mexico2007013144► Subscribe
Serbia51216► Subscribe
CroatiaP20170022► Subscribe
European Patent Office2360164► Subscribe
Luxembourg92555► 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: JARDIANCE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2014035,C1730131Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2014035Lithuania► SubscribePRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
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
0872Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115
2017000024Germany► SubscribePRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
/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
2014000099Germany► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131/01Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
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Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Harvard Business School
Healthtrust
Cantor Fitzgerald
US Department of Justice
Chubb
Johnson and Johnson
Cipla
Moodys

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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