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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
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Mallinckrodt
McKinsey
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Last Updated: October 15, 2019

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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 patent protection?

Empagliflozin is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim and is included in four NDAs. There are sixteen 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 five patent family members in forty-three countries.

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

Recent Clinical Trials for empagliflozin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novo Nordisk A/SPhase 4
Steno Diabetes Center CopenhagenPhase 4
Kobe UniversityPhase 3

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

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 206111-001 Aug 26, 2015 RX Yes No   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No   See Pricing   See Pricing Y   See Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No   See Pricing   See Pricing   See Pricing
>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
2187879 2017/018 Ireland   See Pricing PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131 PA2014035 Lithuania   See Pricing PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 122014000099 Germany   See Pricing PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879 122017000024 Germany   See Pricing PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
1730131 C01730131/01 Switzerland   See Pricing PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
2187879 1790019-2 Sweden   See Pricing PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
1730131 568 Finland   See Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Express Scripts
McKesson
Harvard Business School

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