Deep knowledge on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: ENABLEX

« Back to Dashboard
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-two 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: see list3

Pharmacology for Tradename: ENABLEX

Clinical Trials for: ENABLEX

Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.
Status: Not yet recruiting Condition: Bioequivalency

Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.
Status: Not yet recruiting Condition: Bioequivalency

2 Week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Yrs) With Neurogenic Detrusor Overactivity
Status: Suspended Condition: Neurogenic Detrusor Overactivity

Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain
Status: Recruiting Condition: Bladder Spasms; Ureteral Stent Pain; Postoperative

Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
Status: Active, not recruiting Condition: Overactive Bladder

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
Status: Completed Condition: Healthy

Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
Status: Completed Condition: Overactive Bladder (OAB)

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
Status: Completed Condition: Healthy

Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Status: Completed Condition: Healthy Volunteers

Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
Status: Completed Condition: Urinary Incontinence

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;ORAL021513-002Dec 22, 2004RXYes5,096,890<disabled>YY<disabled>
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>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: ENABLEX

Country Document Number Publication Date
Norway901241Mar 16, 1990
Slovakia129590May 07, 1997
Germany122005000024Aug 04, 2005
Hong Kong130294Dec 02, 1994
Austria269076Jul 15, 2004
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a free trial or see the plan comparison

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 information. There is no warranty that the information contained herein is error free. 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.

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).

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn
`abc