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Serving leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Federal Trade Commission
Colorcon
Fuji
Cipla
Chubb
UBS
AstraZeneca
Johnson and Johnson

Generated: February 23, 2018

DrugPatentWatch Database Preview

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 thirteen 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.

There are eight drug master file entries for empagliflozin. Two suppliers are listed for this compound.
Summary for empagliflozin
Pharmacology for empagliflozin

US Patents and Regulatory Information 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 GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 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 Y ➤ Sign Up
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ 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 Y ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 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 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
7,687,469 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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International Patents for empagliflozin

Supplementary Protection Certificates for empagliflozin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00054 Denmark ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
2017000024 Germany ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
/2017 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
1730131/02 Switzerland ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2014035 Lithuania ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
0140033 00134 Estonia ➤ Sign Up PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
/2014 Austria ➤ Sign Up PRODUCT 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
2017014 Lithuania ➤ Sign Up PRODUCT 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
0 5026-2014 Slovakia ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
0872 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Colorcon
Merck
QuintilesIMS
Covington
Dow
Medtronic
Daiichi Sankyo
UBS

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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