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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-eight 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.

US ANDA Litigation and Generic Entry Outlook for Farxiga

Farxiga was eligible for patent challenges on January 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 16, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $946mm indicating the motivation for generic entry.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (dapagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FARXIGA

International Patents:	338
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	104
Clinical Trials:	28
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
Emory University	Phase 4
Consano Clinical Research, LLC	Phase 4
Mackay Memorial Hospital	Phase 4

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			Y
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

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

International Patents for FARXIGA

Country	Patent Number	Estimated Expiration
South Korea	101772776
Denmark	2409707
Philippines	12000002657
Slovenia	2347762
Peru	20080349

Supplementary Protection Certificates for FARXIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1734971	2012C/017	Belgium		PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
1734971	C 2012 010	Romania		PRODUCT NAME: EXENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/11/696/001, EU/1/11/696/002; DATE OF NATIONAL AUTHORISATION: 20110623; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/696/001, EMEA EU/1/11/696/002; DATE OF FIRST AUTHORISATION IN EEA: 20110623
1506211	SPC/GB13/021	United Kingdom		PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1734971	300526	Netherlands		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617