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Generated: July 16, 2018

DrugPatentWatch Database Preview

Dapagliflozin - Generic Drug Details

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

Dapagliflozin
is the generic ingredient in three branded drugs marketed by Astrazeneca Ab and is included in three 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 two patent family members in forty-four countries.

There are twenty drug master file entries for dapagliflozin. Two suppliers are listed for this compound.
Summary for dapagliflozin
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
(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-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
BMS-512148, Dapagliflozin
BMS5121458
BMS512148
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)-
D01TNW
D08897
Dapagliflozin (INN/USAN)
Dapagliflozin (USAN/INN)
Dapagliflozin [USAN:INN]
dapagliflozin propanediol monohydrate
Dapagliflozin propylene glycolate hydrate
dapaglifozin
DB06292
EX-7214
EX-A005
Farxiga
Forxiga
Forxiga (TN)
FT-0665469
GLU006
GTPL4594
HY-10450
J-500392
JVHXJTBJCFBINQ-ADAARDCZSA-N
KS-000006UW
MFCD13182359
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 FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-005 Jul 28, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Non-Orange Book US Patents for dapagliflozin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Try a Free Trial
8,389,472 Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease ➤ Try a Free Trial
9,884,092 Methods for treating diabetes and reducing body weight ➤ Try a Free Trial
7,612,176 Polymer-based sustained release device ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dapagliflozin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
182 Luxembourg ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2012000028 Germany ➤ Try a Free Trial PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
90017-0 Sweden ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
2013008,C1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Deloitte
Cantor Fitzgerald
Colorcon
Covington
Argus Health
Julphar
Farmers Insurance
QuintilesIMS

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