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Empagliflozin - Generic Drug Details

What are the generic sources for empagliflozin and what is the scope of empagliflozin freedom to operate?

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

There are twenty-one drug master file entries for empagliflozin. Three suppliers are listed for this compound.

Summary for empagliflozin

US Patents:	15
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	21
Suppliers / Packagers:	3
Bulk Api Vendors:	56
Clinical Trials:	138
Patent Applications:	125
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin
DailyMed Link:	empagliflozin at DailyMed

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
(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
BC600492
BDBM150162
BI 10773
BI-10773
BI-10773;Empagliflozin
BI10773
C23H27ClO7
CE0108
CHEBI:82720
CHEMBL2107830
CS-0940
D06ALD
D0P7PD
D10459
DB09038
Empagliflozin (BI-10773;BI 10773;BI10773)
Empagliflozin (BI 10773)
Empagliflozin (BI10773)
Empagliflozin (JAN/USAN/INN)
Empagliflozin [USAN:INN]
Empagliflozin/linagliptin
EX-A414
GTPL4754
HDC1R2M35U
HY-15409
JARDIANCE
Jardiance (TN)
KB-76792
KS-0000072W
MFCD22566222
MolPort-027-720-828
PB23119
Q-4526
s8022
SC-15843
SCHEMBL899986
ST24046679
Tube106
UNII-HDC1R2M35U
US8980829, EMPAGLIFLOZIN
VA10802
X5927
ZINC36520252

US Patents and Regulatory Information for empagliflozin

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Glossary

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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	206111-003	Aug 26, 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				➤ Sign Up
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	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

International Patents for empagliflozin

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Country	Document Number	Estimated Expiration
Eurasian Patent Organization	013079	➤ Sign Up
Serbia	51216	➤ Sign Up
China	103467423	➤ Sign Up
Portugal	1730131	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for empagliflozin

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131/01	Switzerland	➤ Sign Up	PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131/02	Switzerland	➤ Sign Up	PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
00696	Netherlands	➤ Sign Up	PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
90061-7	Sweden	➤ Sign Up	PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description