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Darifenacin hydrobromide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for darifenacin hydrobromide?

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

Darifenacin hydrobromide has forty-five patent family members in thirty-one countries.

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

Summary for Generic Name: darifenacin hydrobromide

Tradenames:2
Patents:2
Applicants:6
NDAs:6
Drug Master File Entries: see list19
Suppliers / Packagers: see list10
Bulk Api Vendors: see list41
Clinical Trials: see list29
Patent Applications: see list26
Therapeutic Class:Genitourinary Agents
Drug Prices:see low prices
DailyMed Link:darifenacin hydrobromide at DailyMed

Pharmacology for Ingredient: darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL206743-002Sep 19, 2016RXNoNo► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004RXYesNo6,106,864► SubscribeY ► Subscribe
Torrent Pharms Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL205209-002Nov 17, 2016RXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL206743-001Sep 19, 2016RXNoNo► Subscribe► Subscribe
Jubilant Generics
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL205550-002Oct 12, 2016RXNoNo► 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, 20045,096,890► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 20046,106,864► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 20046,106,864► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 20045,096,890► Subscribe
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International Patent Family for Ingredient: darifenacin hydrobromide

Country Document Number Estimated Expiration
Spain2188782► Subscribe
New Zealand316924► Subscribe
Germany69632753► Subscribe
World Intellectual Property Organization (WIPO)9709980► Subscribe
Denmark1245231► 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
/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
163Luxembourg► Subscribe91163, EXPIRES: 20191022
0850059/01Switzerland► SubscribeFORMER OWNER: NOVARTIS AG, CH
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
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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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