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Darifenacin hydrobromide - Generic Drug Details

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

This ingredient has forty-five patent family members in thirty-one countries.

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

Summary for Generic Name: darifenacin hydrobromide

Tradenames:2
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list19
Suppliers / Packaging: see list8
Therapeutic Class:Genitourinary Agents
Drug Prices:see low prices

Pharmacology for Ingredient: darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anchen Pharms
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL091190-001Mar 13, 2015RXNo► subscribe► subscribe
Anchen Pharms
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL091190-002Mar 13, 2015RXNo► subscribe► subscribe
Cipla Ltd
DARIFENACIN HYDROBROMIDE
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL207664-001Sep 1, 2016RXNo► 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;ORAL021513-002Dec 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
New Zealand316924► subscribe
Poland325598► subscribe
Poland185604► 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 ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - 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
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
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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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