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ENABLEX Drug Profile

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Enablex is a drug marketed by Apil and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for Tradename: ENABLEX

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Drug Prices: :see details

Pharmacology for Tradename: ENABLEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004RXNo6,106,864► subscribeY ► subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004RXYes6,106,864► subscribeY ► subscribe
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Expired Patents for Tradename: ENABLEX

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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Paragraph IV activity for: ENABLEX

Drugname Dosage Strength RLD Submissiondate
darifenacin hydrobromideExtended-release Tablets7.5 mg and 15 mgEnablex12/22/2008

International Patent Family for Tradename: ENABLEX

Country Document Number Estimated Expiration
Colombia4750822► subscribe
Portugal1245231► subscribe
Cyprus2468► 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: ENABLEX

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
163Luxembourg► subscribe91163, EXPIRES: 20191022
/2005Austria► subscribePRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - 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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