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Serving leading biopharmaceutical companies globally:

Accenture
Moodys
Chinese Patent Office
Harvard Business School
Farmers Insurance
AstraZeneca
Cantor Fitzgerald
Chubb
Cerilliant
Cipla

Generated: November 18, 2017

DrugPatentWatch Database Preview

Darifenacin hydrobromide - Generic Drug Details

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What are the generic sources for darifenacin hydrobromide and what is the scope of darifenacin hydrobromide patent protection?

Darifenacin hydrobromide
is the generic ingredient in three branded drugs marketed by Macleods Pharms Ltd, Torrent Pharms Ltd, Apil, Aurobindo Pharma Ltd, Jubilant Generics, Cipla Ltd, and Anchen Pharms, and is included in seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Darifenacin hydrobromide has forty-eight patent family members in thirty-one countries and ten supplementary protection certificates in eight countries.

There are nineteen drug master file entries for darifenacin hydrobromide. Eleven suppliers are listed for this compound.

Summary for darifenacin hydrobromide

Pharmacology for darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd
DARIFENACIN
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL207302-002Jul 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Torrent Pharms Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL205209-001Nov 17, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL206743-001Sep 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL205550-001Oct 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL207664-002Sep 1, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL205209-002Nov 17, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Macleods Pharms Ltd
DARIFENACIN
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL207302-001Jul 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL207664-001Sep 1, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: darifenacin hydrobromide

Country Document Number Estimated Expiration
Denmark0850059► Subscribe
China1303998► Subscribe
Japan3403203► Subscribe
Brazil9610153► Subscribe
Australia703866► Subscribe
Cyprus2468► Subscribe
Spain2188782► Subscribe
Colombia4750822► Subscribe
Poland325598► Subscribe
European Patent Office0850059► 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: DARIFENACIN HYDROBROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
163Luxembourg► Subscribe91163, EXPIRES: 20191022
/2005Austria► SubscribePRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
0190Netherlands► Subscribe300190, 20160821, EXPIRES: 20191021
C0017France► SubscribePRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022
/2005Austria► SubscribePRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - EU/1/04/294/012 20041022
C012/2005Ireland► SubscribeSPC012/2005, 20060725, EXPIRES: 20191021
0850059/01Switzerland► SubscribeFORMER OWNER: NOVARTIS AG, CH
2005 00020Denmark► Subscribe
C/GB05/022United Kingdom► SubscribePRODUCT NAME: DARIFENACIN HYDROBROMIDE; REGISTERED: UK EU/1/04/294/001 20041022; UK EU/1/04/294/002 20041022; UK EU/1/04/294/003 20041022; UK EU/1/04/294/004 20041022; UK EU/1/04/294/005 20041022; UK EU/1/04/294/006 20041022; UK EU/1/04/294/007 20041022; UK EU/1/04/294/008 20041022; UK EU/1/04/294/009 20041022; UK EU/1/04/294/010 20041022; UK EU/1/04/294/011 20041022; UK EU/1/04/294/012 20041022
00191Netherlands► SubscribePRODUCT NAME: DARIFENACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROBROMIDE; REGISTRATION NO/DATE: EU1/04/294/001 - 012, 20041022
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Express Scripts
UBS
US Department of Justice
Cerilliant
QuintilesIMS
AstraZeneca
Deloitte
Teva

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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