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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.

Summary for FARXIGA

International Patents:	332
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	103
Clinical Trials:	27
Patent Applications:	341
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FARXIGA
Drug Sales Revenues:	Drug sales revenues for FARXIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FARXIGA
DailyMed Link:	FARXIGA at DailyMed

See drug prices for FARXIGA

See drug sales revenues for FARXIGA

Generic Entry Opportunity Date for FARXIGA

NDA:

202293

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

Sponsor	Phase
Consano Clinical Research, LLC	Phase 4
Mackay Memorial Hospital	Phase 4
Jeff Burns, MD	Phase 1/Phase 2

See all FARXIGA clinical trials

Recent Litigation for FARXIGA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 LIMITED	2018-01-09

See all FARXIGA litigation

PTAB Litigation

Petitioner	Date
Luye Pharma Group Ltd.	2016-05-31

See all FARXIGA litigation

Pharmacology for FARXIGA

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

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

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
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014

International Patents for FARXIGA

Country	Patent Number	Estimated Expiration
South Korea	20070011506
Japan	5937187
Croatia	P20150272
Argentina	065809

Supplementary Protection Certificates for FARXIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CR 2014 00037	Denmark		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		PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
1506211	42/2014	Austria		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		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617