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FARXIGA Drug Profile

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Which patents cover Farxiga, and what substitute generic drugs are available?

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

This drug has one hundred and ninety-one patent family members in forty-three countries.

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

Summary for Tradename: FARXIGA

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list67
Clinical Trials: see list18
Patent Applications: see list145
Drug Prices:see details
DailyMed Link:FARXIGA at DailyMed

Pharmacology for Tradename: FARXIGA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo6,515,117► SubscribeYY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes8,361,972► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes7,919,598► SubscribeY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo9,198,925► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo6,414,126► 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
Japan5475636► Subscribe
Eurasian Patent Organization018229► Subscribe
European Patent Office2069374► Subscribe
Canada2681526► Subscribe
Japan4365554► 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
2013 00019Denmark► Subscribe
2013008Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
C0022France► SubscribePRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
136; 5005-2013Slovakia► SubscribePRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
0140021 00131Estonia► SubscribePRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
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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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