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Serving leading biopharmaceutical companies globally:

Medtronic
Daiichi Sankyo
Cerilliant
Queensland Health
McKinsey
Johnson and Johnson
Boehringer Ingelheim
Fish and Richardson
Chinese Patent Office
Teva

Generated: February 19, 2018

DrugPatentWatch Database Preview

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.

This drug has three hundred and two patent family members in forty-four countries.

The generic ingredient in FARXIGA is dapagliflozin propanediol. There are twenty 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 FARXIGA
International Patents:302
US Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 67
Clinical Trials: 21
Patent Applications: 326
Drug Prices:see details
DailyMed Link:FARXIGA at DailyMed
Drug patent expirations by year for FARXIGA
Pharmacology for FARXIGA

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 propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for FARXIGA

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

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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
8,877,252 Polymer-based sustained release device ➤ Sign Up
7,612,176 Polymer-based sustained release device ➤ Sign Up
8,389,472 Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease ➤ Sign Up
8,617,613 Polymer-based sustained release device ➤ Sign Up
8,998,876 Ampoule comprising an ampoule holder ➤ Sign Up
8,293,871 Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar ➤ Sign Up
7,563,871 Polymer-based sustained release device ➤ Sign Up
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for FARXIGA

Supplementary Protection Certificates for FARXIGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00015 Denmark ➤ Sign Up
2013008,C1506211 Lithuania ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211/01 Switzerland ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
136; 5005-2013 Slovakia ➤ Sign Up PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
6 5005-2013 Slovakia ➤ Sign Up 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
2014026,C1506211 Lithuania ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
9 5017-2014 Slovakia ➤ Sign Up PRODUCT 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
/2013 Austria ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2013000033 Germany ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
2014000070 Germany ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Medtronic
Queensland Health
Julphar
Johnson and Johnson
Boehringer Ingelheim
Mallinckrodt
Citi

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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