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Last Updated: February 29, 2020

DrugPatentWatch Database Preview

Empagliflozin - Generic Drug Details

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

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

Empagliflozin has two hundred and forty-two patent family members in forty-four countries.

There are twenty-two drug master file entries for empagliflozin. Five suppliers are listed for this compound.

Recent Clinical Trials for empagliflozin

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SponsorPhase
VU University Medical CenterPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1
University of VirginiaEarly Phase 1

See all empagliflozin clinical trials

Recent Litigation for empagliflozin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited2019-08-28
Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited2019-07-11
Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited2018-11-08

See all empagliflozin litigation

Pharmacology for empagliflozin
Synonyms for empagliflozin
(1S)-1,5-anhydro-1-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucitol
(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol
(1S)-1,5-anhydro-1-C-{4-chloro-3-((4-{((3S)-oxolan-3-yl)oxy}phenyl)methyl)phenyl}-D-glucitol
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(((S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-chloro-3-({4-[(3S)-oxolan-3-yloxy]phenyl}methyl)phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL
(2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-tetrahydrofuran-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol
(S)-Empagliflozin D4
1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene
1314556-33-6
4CH-023469
864070-44-0
AC-27643
AJ-93046
AK160980
AKOS024464680
AX8293990
BBL104150
BC600492
BDBM150162
BI 10773
BI-10773
BI-10773;Empagliflozin
BI10773
C23H27ClO7
CE0108
CHEBI:82720
CHEMBL2107830
CS-0940
D10459
DB09038
DS-9824
Empagliflozin (BI-10773;BI 10773;BI10773)
Empagliflozin (BI 10773)
Empagliflozin (BI10773)
Empagliflozin (JAN/USAN/INN)
Empagliflozin [USAN:INN]
EX-A414
GTPL4754
HDC1R2M35U
HY-15409
JARDIANCE
Jardiance (TN)
KB-76792
KS-0000072W
MolPort-027-720-828
PB23119
Q-4526
s8022
SC-15843
SCHEMBL899986
ST24046679
STL557964
SW219120-1
Tube106
UNII-HDC1R2M35U
US8980829, EMPAGLIFLOZIN
VA10802
X5927
ZINC36520252
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN
Tradename Dosage Ingredient NDA Submissiondate
JARDIANCE TABLET;ORAL empagliflozin 204629 2018-08-01

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 SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for empagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/01 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131 C 2014 039 Romania   Start Trial PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522
1730131 C01730131/02 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2187879 122017000024 Germany   Start Trial PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2187879 CA 2017 00019 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
1730131 PA2014035,C1730131 Lithuania   Start Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
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Medtronic
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