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Serving 500+ biopharmaceutical companies globally:

Covington
Dow
Medtronic
QuintilesIMS
McKesson
Fish and Richardson
US Department of Justice
Healthtrust
Baxter
Farmers Insurance

Generated: September 20, 2017

DrugPatentWatch Database Preview

QTERN Drug Profile

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Which patents cover Qtern, and when can generic versions of Qtern launch?

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

This drug has two hundred and ninety-five patent family members in forty-seven countries.

The generic ingredient in QTERN is dapagliflozin propanediol; saxagliptin hydrochloride. There are eight drug master file entries for this compound. Additional details are available on the dapagliflozin propanediol; saxagliptin hydrochloride profile page.

Summary for Tradename: QTERN

Patents:11
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:QTERN at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► 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► 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
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► SubscribeY ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Tradename: QTERN

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
7,951,400Coated tablet formulation and method► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► Subscribe
7,851,502Pharmaceutical formulations containing an SGLT2 inhibitor► Subscribe
9,339,472Coated tablet formulation and method► 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: QTERN

Country Document Number Estimated Expiration
Japan5313889► Subscribe
Cyprus1117813► Subscribe
Eurasian Patent Organization020428► Subscribe
Japan4460205► Subscribe
Japan2014111636► Subscribe
Hungary230380► Subscribe
Norway323698► Subscribe
Japan2010077163► Subscribe
Eurasian Patent Organization020288► Subscribe
Taiwan200609002► 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: QTERN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000070Germany► 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
/2013Austria► SubscribePRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
6 5005-2013Slovakia► SubscribePRODUCT 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
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
90017-0Sweden► SubscribePRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
C0028France► SubscribePRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
2013 008, C 1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
00436Netherlands► SubscribePRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
496Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Cipla
Colorcon
McKinsey
Moodys
Daiichi Sankyo
Novartis
Federal Trade Commission
Chinese Patent Office

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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