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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 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.

Summary for empagliflozin

International Patents:	242
US Patents:	17
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	22
Suppliers / Packagers:	5
Bulk Api Vendors:	67
Clinical Trials:	176
Patent Applications:	146
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin
DailyMed Link:	empagliflozin at DailyMed

Recent Clinical Trials for empagliflozin

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

Sponsor	Phase
VU University Medical Center	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1
University of Virginia	Early Phase 1

See all empagliflozin clinical trials

Recent Litigation for empagliflozin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited	2019-08-28
Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited	2019-07-11
Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited	2018-11-08

See all empagliflozin litigation

Pharmacology for empagliflozin

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

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
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No

International Patents for empagliflozin

Country	Patent Number	Estimated Expiration
European Patent Office	1730131
Israel	241102
Norway	2014028
Denmark	2187879
Lithuania	PA2017014
Peru	20091063

Supplementary Protection Certificates for empagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131	C 2014 039	Romania		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		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2187879	122017000024	Germany		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		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		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522