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Last Updated: December 9, 2019

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FARXIGA Drug Profile

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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 thirty-two patent family members in forty-five countries.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.

Drug patent expirations by year for FARXIGA
Drug Prices for FARXIGA

See drug prices for FARXIGA

Drug Sales Revenue Trends for FARXIGA

See drug sales revenues for FARXIGA

Generic Entry Opportunity Date for FARXIGA
Generic Entry Date for FARXIGA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FARXIGA

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

SponsorPhase
Consano Clinical Research, LLCPhase 4
Mackay Memorial HospitalPhase 4
Jeff Burns, MDPhase 1/Phase 2

See all FARXIGA clinical trials

Recent Litigation for FARXIGA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.2019-07-17
AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc.2018-05-01
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2018-01-09

See all FARXIGA litigation

PTAB Litigation
PetitionerDate
Luye Pharma Group Ltd.2016-05-31

See all FARXIGA litigation

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
(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-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol, (2S)-propane-1,2-diol (1:1) monohydrate
(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)oxane-3,4,5-triol;(2S)-propane-1,2-diol;hydrate
(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
(2S)-propane-1,2-diol--(1S)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-D-glucitol--water (1/1/1)
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
887K2391VH
960404-48-2
A25150
AB1008441
AC-24699
AC-29230
AJ-45726
AK161692
AK322430
AKOS005145763
AKOS027250601
AMX10145
AN-431
AOB87300
API0007667
AX8161909
BCP9000583
BCPP000265
BDBM20880
BDBM50448923
BMS 512148
BMS-512148
BMS-512148-05
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
CHEBI:85079
CHEMBL2103802
CHEMBL3125458
CHEMBL429910
CS-0781
CS-3077
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)-, compd. with (2S)-1,2-propanediol, hydrate (1:1:1)
D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-
D08897
Dapagliflozin
Dapagliflozin ((2S)-1,2-propanediol, hydrate)
Dapagliflozin (2S)-1,2-Propanediol Monohydrate
dapagliflozin (S)-propylene glycol hydrate
Dapagliflozin (USAN/INN)
Dapagliflozin [USAN:INN]
Dapagliflozin mixture with propylene glycol, hydrate
Dapagliflozin propanediol
Dapagliflozin propanediol [USAN]
Dapagliflozin propanediol hydrate
dapagliflozin propanediol monohydrate
DAPAGLIFLOZIN PROPYLENE GLYCOL
Dapagliflozin propylene glycol hydrate
Dapagliflozin propylene glycolate hydrate
Dapagliflozin S-propylene glycol monohydrate
DB06292
EX-7214
EX-A005
Forxiga
Forxiga (TN)
FT-0665469
GLU006
GTPL4594
HY-10450
HY-10450A
J-500392
JVHXJTBJCFBINQ-ADAARDCZSA-N
KS-000006UW
KS-00000SPY
MolPort-009-682-875
MolPort-039-337-086
PB11055
PubChem22435
Q-3845
RL03723
s1548
S1548_Selleck
SC-25116
SCHEMBL157820
ST24046416
Tube101
UNII-1ULL0QJ8UC
UNII-887K2391VH
ZINC3819138
Paragraph IV (Patent) Challenges for FARXIGA
Tradename Dosage Ingredient NDA Submissiondate
FARXIGA TABLET;ORAL dapagliflozin 202293 2018-01-08

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   Start Trial   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes   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 FARXIGA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 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
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 FARXIGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 CR 2014 00037 Denmark   Start Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1506211 C01506211/01 Switzerland   Start Trial PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
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
1734971 300526 Netherlands   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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