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Last Updated: March 28, 2024

ENABLEX Drug Patent Profile


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Which patents cover Enablex, and when can generic versions of Enablex launch?

Enablex is a drug marketed by Abbvie and is included in one NDA.

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

Drug patent expirations by year for ENABLEX
Drug Prices for ENABLEX

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Recent Clinical Trials for ENABLEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Astellas Scientific & Medical Affairs, Inc.
Universidad de ValparaisoPhase 3
Recalcine (GynoPharm)Phase 3

See all ENABLEX clinical trials

Paragraph IV (Patent) Challenges for ENABLEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ENABLEX Extended-release Tablets darifenacin hydrobromide 7.5 mg and 15 mg 021513 3 2008-12-22

US Patents and Regulatory Information for ENABLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ENABLEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ENABLEX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
pharmaand GmbH Emselex darifenacin hydrobromide EMEA/H/C/000554
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Authorised no no no 2004-10-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ENABLEX

See the table below for patents covering ENABLEX around the world.

Country Patent Number Title Estimated Expiration
Hungary 227397 PHARMACEUTICAL FORMULATIONS CONTAINING DARIFENACIN ⤷  Try a Trial
Hungary T58313 ⤷  Try a Trial
Denmark 0850059 ⤷  Try a Trial
Hong Kong 130294 Pyrrolidine derivatives ⤷  Try a Trial
Hungary 225236 PHARMACEUTICAL FORMULATIONS CONTAINING DARIFENACIN ⤷  Try a Trial
Germany 69626397 ⤷  Try a Trial
Portugal 1245231 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ENABLEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0850059 22/2005 Austria ⤷  Try a Trial PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
0850059 300190 Netherlands ⤷  Try a Trial 300190, 20160821, EXPIRES: 20191021
0850059 91163 Luxembourg ⤷  Try a Trial 91163, EXPIRES: 20191022
0850059 C00850059/01 Switzerland ⤷  Try a Trial FORMER OWNER: NOVARTIS AG, CH
0388054 91161 Luxembourg ⤷  Try a Trial 91161, EXPIRES: 20150302
0388054 CA 2005 00019 Denmark ⤷  Try a Trial
0850059 SPC012/2005 Ireland ⤷  Try a Trial SPC012/2005, 20060725, EXPIRES: 20191021
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.