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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Dow
Colorcon
Fish and Richardson
Deloitte
Chinese Patent Office
UBS
Chubb
Argus Health

Generated: October 19, 2017

DrugPatentWatch Database Preview

FARXIGA Drug Profile

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What is the patent landscape for Farxiga, and when can generic versions of Farxiga launch?

Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and three patent family members in forty-four countries and twenty-six supplementary protection certificates in twelve countries.

The generic ingredient in FARXIGA is dapagliflozin propanediol. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin propanediol profile page.

Summary for Tradename: FARXIGA

US Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list67
Clinical Trials: see list20
Drug Prices:see details
DailyMed Link:FARXIGA at DailyMed

Pharmacology for Tradename: 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 propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: 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
9,453,039Crystal structures of SGLT2 inhibitors and processes for preparing same► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FARXIGA

Country Document Number Estimated Expiration
Singapore172741► Subscribe
Germany60311649► Subscribe
Eurasian Patent Organization201490477► Subscribe
Taiwan200904405► Subscribe
Slovenia2069374► Subscribe
Colombia5251414► Subscribe
South Korea101493102► Subscribe
Austria295848► Subscribe
Poland204358► Subscribe
Brazil0014722► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FARXIGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000071Germany► SubscribePRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
496Luxembourg► SubscribePRODUCT 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
1506211/01Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
2013000033Germany► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
6 5005-2013Slovakia► SubscribePRODUCT 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
0677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
182Luxembourg► SubscribePRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2014 00037Denmark► SubscribePRODUCT 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
/2013Austria► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
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Serving leading biopharmaceutical companies globally:

Cipla
US Department of Justice
Johnson and Johnson
Mallinckrodt
Baxter
Julphar
QuintilesIMS
US Army
Fuji
Accenture

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.

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