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Serving 500+ biopharmaceutical companies globally:

Merck
Fish and Richardson
Cipla
Boehringer Ingelheim
Fuji
Queensland Health
Colorcon
Moodys
Deloitte
Chubb

Generated: August 19, 2017

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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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: dapagliflozin propanediol

Tradenames:3
Patents:13
Applicants:1
NDAs:3
Drug Master File Entries: see list8
Suppliers / Packagers: see list2
Clinical Trials: see list153
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;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► 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
Taiwan200811127► Subscribe
New Zealand589190► Subscribe
Israel214180► Subscribe
South Korea20140069365► Subscribe
Taiwan200904405► 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
90017-0Sweden► SubscribePRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
00677Netherlands► 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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION 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 500+ biopharmaceutical companies globally:

Chubb
Accenture
Boehringer Ingelheim
Chinese Patent Office
Dow
Express Scripts
Citi
Merck
Mallinckrodt
Daiichi Sankyo

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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