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Last Updated: October 16, 2019

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DAPAGLIFLOZIN - Generic Drug Details

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

Dapagliflozin is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in four NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin has three hundred and twenty-five patent family members in forty-five countries.

There are twenty-six drug master file entries for dapagliflozin. Three suppliers are listed for this compound.

Summary for DAPAGLIFLOZIN
Recent Clinical Trials for DAPAGLIFLOZIN

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

SponsorPhase
University Hospital Inselspital, BernePhase 3
Swedish National Board of Health and WelfarePhase 4
The Swedish National Diabetes RegisterPhase 4

See all DAPAGLIFLOZIN clinical trials

Pharmacology for DAPAGLIFLOZIN
Synonyms for DAPAGLIFLOZIN
(1S)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-D-glucitol
(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol
(2S, 3R, 4R, 5S, 6R)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2H-pyran-3,4,5-triol;BMS-512148
(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol
1-[3-(beta-D-Glucopyranosyl)-6-chlorobenzyl]-4-ethoxybenzene
1ULL0QJ8UC
2-(3-(4-Ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
432D268
461432-26-8
A25150
AB1008441
AC-24699
AJ-45726
AK161692
AKOS005145763
AMX10145
AN-431
AOB87300
API0007667
AX8161909
BCP9000583
BCPP000265
BDBM20880
BDBM50448923
BMS 512148
BMS-512148
BMS-512148, 461432-26-8
BMS5121458
BMS512148
BRD-K58160573-001-01-3
BRD-K58160573-001-05-4
C-aryl glucoside, 6
CCG-229917
CD0219
CHEBI:85078
CHEMBL3125458
CHEMBL429910
CS-0781
D-Glucitol, 1,5-anhydro-1-C-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1S)-
D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-
D08897
Dapagliflozin (USAN/INN)
Dapagliflozin [USAN:INN]
DB06292
EX-7214
EX-A005
Farxiga
Forxiga
Forxiga (TN)
FT-0665469
GLU006
GTPL4594
HY-10450
J-500392
JVHXJTBJCFBINQ-ADAARDCZSA-N
KS-000006UW
MolPort-009-682-875
PB11055
PubChem22435
Q-3845
RL03723
s1548
S1548_Selleck
SC-25116
SCHEMBL157820
ST24046416
Tube101
UNII-1ULL0QJ8UC
ZINC3819138

US Patents and Regulatory Information for DAPAGLIFLOZIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DAPAGLIFLOZIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DAPAGLIFLOZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971 91989 Luxembourg   Start Trial 91989, EXPIRES: 20260617
1506211 42/2014 Austria   Start Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1506211 C300677 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
>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
Colorcon
Harvard Business School
Medtronic
McKesson

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