.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
Baxter
Federal Trade Commission
McKinsey
Argus Health
Cerilliant
US Army
Dow
McKesson

Generated: December 15, 2017

DrugPatentWatch Database Preview

ENABLEX Drug Profile

« Back to Dashboard

When do Enablex patents expire, and what generic alternatives are available?

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

This drug has forty-eight patent family members in thirty-one countries and ten supplementary protection certificates in eight countries.

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

Summary for ENABLEX

Drug patent expirations by year for ENABLEX

Pharmacology for ENABLEX

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: ENABLEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004► Subscribe► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004► Subscribe► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004► Subscribe► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges 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
World Intellectual Property Organization (WIPO)9709980► Subscribe
Denmark1245231► Subscribe
Russian Federation2163803► Subscribe
Spain2224002► Subscribe
Czech Republic9800732► Subscribe
Norway2005009► Subscribe
Mexico9802026► Subscribe
Taiwan442300► Subscribe
Germany69626397► Subscribe
Brazil9610153► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ENABLEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2005 00020Denmark► Subscribe
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
0190Netherlands► Subscribe300190, 20160821, EXPIRES: 20191021
0850059/01Switzerland► SubscribeFORMER OWNER: NOVARTIS AG, CH
/2005Austria► SubscribePRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
/2005Austria► SubscribePRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - EU/1/04/294/012 20041022
163Luxembourg► Subscribe91163, EXPIRES: 20191022
C012/2005Ireland► SubscribeSPC012/2005, 20060725, EXPIRES: 20191021
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Johnson and Johnson
UBS
McKinsey
Accenture
Covington
Fish and Richardson
Queensland Health
Colorcon
Medtronic

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot