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Profile for Tradename: ENABLEX

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Enablex is a drug marketed by Warner Chilcott Llc and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-three patent family members in forty-one countries.

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

Summary for Tradename: ENABLEX

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list9

Pharmacology for Tradename: ENABLEX

Clinical Trials for: ENABLEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004RXNo5,096,890<disabled>YY<disabled>
Warner Chilcott Llc
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004RXYes6,106,864<disabled>Y<disabled>
Warner Chilcott Llc
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004RXNo6,106,864<disabled>Y<disabled>
Warner Chilcott Llc
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004RXYes5,096,890<disabled>YY<disabled>
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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

Non-Orange Book Patents for Tradename: ENABLEX

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
5,233,053 Pyrrolidine derivatives<disabled in preview>
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International Patent Family for Tradename: ENABLEX

Country Document Number Publication Date
Japan3403203May 06, 2003
Netherlands300191Aug 01, 2005
Hungary211640Dec 28, 1995
Hungary901580Jun 28, 1990
Czech Republic9800732Mar 17, 1999
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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.

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Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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