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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 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

International Patents:	302
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	71
Clinical Trials:	21
Patent Applications:	327
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	FARXIGA at DailyMed

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

(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
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	Y

Expired US Patents for FARXIGA

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

Paragraph IV (Patent) Challenges for FARXIGA

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	5 mg and 10 mg		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
8,877,252	Polymer-based sustained release device
8,389,472	Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease
7,612,176	Polymer-based sustained release device

International Patents for FARXIGA

Country	Document Number	Estimated Expiration
Peru	01852009
Taiwan	I421245
Canada	2653344
Mexico	339143

Supplementary Protection Certificates for FARXIGA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012006	Lithuania		PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
6 5005-2013	Slovakia		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		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
/2012	Austria		PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623