DARIFENACIN HYDROBROMIDE - Generic Drug Details

What are the generic sources for darifenacin hydrobromide and what is the scope of freedom to operate?

Darifenacin hydrobromide is the generic ingredient in three branded drugs marketed by Macleods Pharms Ltd, Alembic, Aurobindo Pharma, Cipla, Endo Operations, Jubilant Generics, Polygen Pharms, Torrent, Xiromed, and Abbvie, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for darifenacin hydrobromide. Nine suppliers are listed for this compound.

Summary for DARIFENACIN HYDROBROMIDE

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	1
Patent Applications:	33
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DARIFENACIN HYDROBROMIDE
What excipients (inactive ingredients) are in DARIFENACIN HYDROBROMIDE?	DARIFENACIN HYDROBROMIDE excipients list
DailyMed Link:	DARIFENACIN HYDROBROMIDE at DailyMed

Recent Clinical Trials for DARIFENACIN HYDROBROMIDE

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

Sponsor	Phase
Ontario Neurotrauma Foundation	Phase 4
Toronto Rehabilitation Institute	Phase 4

See all DARIFENACIN HYDROBROMIDE clinical trials

Pharmacology for DARIFENACIN HYDROBROMIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DARIFENACIN HYDROBROMIDE

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DARIFENACIN HYDROBROMIDE

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 DARIFENACIN HYDROBROMIDE

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	021513-002	Dec 22, 2004		DISCN	Yes	No
Cipla	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207664-001	Sep 1, 2016	AB	RX	No	No
Xiromed	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	209571-002	Oct 22, 2019		DISCN	No	No
Alembic	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207681-001	Dec 8, 2017	AB	RX	No	No
Endo Operations	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	091190-001	Mar 13, 2015		DISCN	No	No
Polygen Pharms	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	211045-002	Jan 6, 2020	AB	RX	No	No
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004		DISCN	Yes	No

Expired US Patents for DARIFENACIN HYDROBROMIDE

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
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004

EU/EMA Drug Approvals for DARIFENACIN HYDROBROMIDE

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