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Serving leading biopharmaceutical companies globally:

Teva
Cipla
Julphar
Daiichi Sankyo
McKinsey
US Army
Merck
Medtronic
Queensland Health
Moodys

Generated: October 23, 2017

DrugPatentWatch Database Preview

Dapagliflozin propanediol - Generic Drug Details

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What are the generic sources for dapagliflozin propanediol and what is the scope of dapagliflozin propanediol patent protection?

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

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

There are sixteen drug master file entries for dapagliflozin propanediol. One supplier is listed for this compound.

Summary for Generic Name: dapagliflozin propanediol

US Patents:14
Tradenames:3
Applicants:1
NDAs:3
Drug Master File Entries: see list16
Suppliers / Packagers: see list1
Clinical Trials: see list155
Drug Prices:see low prices
DailyMed Link:dapagliflozin propanediol at DailyMed

Pharmacology for Ingredient: dapagliflozin propanediol

Applicant Tradename Generic Name Dosage NDA Approval Date TE 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, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► SubscribeY ► 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► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► SubscribeY ► 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
European Patent Office1224195► Subscribe
China1284793► Subscribe
New Zealand518029► Subscribe
China1896088► Subscribe
Australia781009► Subscribe
South Africa200202604► Subscribe
Austria295848► Subscribe
South Korea101502292► Subscribe
Israel195882► Subscribe
TaiwanI519528► 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
0140021 00131Estonia► SubscribePRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
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
2013 00019Denmark► Subscribe
2013000033Germany► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; 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
90017-0Sweden► SubscribePRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
2013008,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Moodys
Chinese Patent Office
Mallinckrodt
Cerilliant
Accenture
Johnson and Johnson
Cantor Fitzgerald
McKesson
UBS

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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