Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Dow
Healthtrust
McKinsey
Farmers Insurance
US Army
Daiichi Sankyo
Colorcon

Generated: April 23, 2018

DrugPatentWatch Database Preview

FARXIGA Drug Profile

« Back to Dashboard

When do Farxiga patents expire, and when can generic versions of Farxiga launch?

Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and two patent family members in forty-four countries.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin profile page.
Summary for FARXIGA
Drug patent expirations by year for FARXIGA
Pharmacology for FARXIGA
Synonyms for FARXIGA
(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
CA000442
CA002484
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
Dapagliflozin (INN/USAN)
Dapagliflozin (USAN/INN)
Dapagliflozin [USAN:INN]
dapagliflozin propanediol monohydrate
Dapagliflozin propylene glycolate hydrate
dapaglifozin
DB06292
EX-7214
EX-A005
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 FARXIGA

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 202293-002 Jan 8, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for FARXIGA

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 202293-002 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 202293-001 Jan 8, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for FARXIGA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2018-01-08

Non-Orange Book US Patents for FARXIGA

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
8,877,252 Polymer-based sustained release device ➤ Try a Free Trial
8,389,472 Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease ➤ Try a Free Trial
7,612,176 Polymer-based sustained release device ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Supplementary Protection Certificates for FARXIGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012006 Lithuania ➤ Try a Free Trial PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
6 5005-2013 Slovakia ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
2013 008, C 1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
/2012 Austria ➤ Try a Free Trial PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
Medtronic
Cipla
Merck
US Department of Justice
McKesson
Dow
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.