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Dapagliflozin propanediol - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dapagliflozin propanediol?

Dapagliflozin propanediol is the generic ingredient in three branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin propanediol has one hundred and ninety-one patent family members in forty-three countries.

There are four drug master file entries for dapagliflozin propanediol. Two suppliers are listed for this compound.

Summary for Generic Name: dapagliflozin propanediol

Tradenames:3
Patents:12
Applicants:1
NDAs:3
Drug Master File Entries: see list4
Suppliers / Packagers: see list2
Clinical Trials: see list83
Drug Prices:see low prices
DailyMed Link:dapagliflozin propanediol at DailyMed

Pharmacology for Ingredient: dapagliflozin propanediol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-002Oct 29, 2014RXYesNo8,685,934► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo8,501,698► SubscribeY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-002Oct 29, 2014RXYesNo8,501,698► SubscribeY ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes9,198,925► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dapagliflozin propanediol

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 Ingredient: dapagliflozin propanediol

Country Document Number Estimated Expiration
Poland210304► Subscribe
Norway20044915► Subscribe
Portugal2069374► Subscribe
Serbia53638► Subscribe
Colombia5251414► 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: DAPAGLIFLOZIN PROPANEDIOL

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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
13/013Ireland► SubscribePRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
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
2013000033Germany► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
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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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