ENABLEX Drug Patent Profile

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When do Enablex patents expire, 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. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Enablex

A generic version of ENABLEX was approved as darifenacin hydrobromide by CIPLA on September 1^st, 2016.

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Summary for ENABLEX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	16
Drug Prices:	Drug price information for ENABLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENABLEX
What excipients (inactive ingredients) are in ENABLEX?	ENABLEX excipients list
DailyMed Link:	ENABLEX at DailyMed

Drug patent expirations by year for ENABLEX

Recent Clinical Trials for ENABLEX

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

Sponsor	Phase
Astellas Scientific & Medical Affairs, Inc.
Universidad de Valparaiso	Phase 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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

EU/EMA Drug Approvals for ENABLEX

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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.

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2015965	PROCESS FOR PREPARING 3-(S)-(-)- (1-CARBAMOYL-1,1- DIPHENYLMETHYL)-1-[2- (2,3-DIHYDROBENZOFURAN-5-YL) ETHYL] PYRROLIDINE OR SALT THEREOF	⤷ Sign Up
Hungary	225236	PHARMACEUTICAL FORMULATIONS CONTAINING DARIFENACIN	⤷ Sign Up
Hungary	211640		⤷ Sign Up
European Patent Office	0388054	Dérivés de la pyrrolidine. (Pyrrolidine derivatives.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ENABLEX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0388054	CA 2005 00019	Denmark	⤷ Sign Up
0850059	300190	Netherlands	⤷ Sign Up	300190, 20160821, EXPIRES: 20191021
0388054	300191	Netherlands	⤷ Sign Up	300191, 20100302, EXPIRES: 20150301
0388054	C300191	Netherlands	⤷ Sign Up	PRODUCT 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ENABLEX

Recent Clinical Trials for ENABLEX

Paragraph IV (Patent) Challenges for ENABLEX

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