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ENABLEX

NDA

DARIFENACIN HYDROBROMIDE | N021513 | ABBVIE INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Warner Chilcott Company LLC et al v. Torrent Pharmaceuticals Limited et al 1:2013cv02039 1 patentANDA 205209darifenacin hydrobromide	D. Del.	2013-12-18	Terminated 2014-07-16	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Xiromed, LLC (Xiromed) on behalf of Xiromed Pharma Espa... FDA-2021-P-1108 · 3 docket documents Xiromed, LLC on behalf of Xiromed Pharma España S.L. submitted this citizen petition requesting that the FDA designate CIPLA LTD's ANDA A207664 as the new Reference Standard for Darifenacin Extended Release Tablets 7.5 mg and 15 mg, since the original RLD ENABLEX manufactured by Allergan has been di	505(q)	2021-10-14	Withdrawn	Xiromed Pharma España S.L.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

18 trials from ClinicalTrials.gov, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder NCT00170755	Phase 3	Completed	Novartis	718	2002-04 → 2005-01
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over NCT00170768	Phase 2	Completed	Novartis	150	2005-02 → 2005-05
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder NCT00127270	Phase 4	Completed	Novartis	395	2005-05 → 2006-02
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.NCT00171145	Phase 3	Completed	Novartis	445	2004-04 → 2004-12
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder NCT00171184	Phase 4	Completed	Novartis	400	2005-04 → 2006-06
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects NCT00703703	Phase 1	Completed	Novartis	117	2008-05 → 2008-10
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease NCT00892450	N/A	Completed	US Department of Veterans Affairs	12	2009-05 → 2014-09
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects NCT00413790	Phase 4	Completed	Novartis	162	2006-11 → 2007-09
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity NCT00800462	Phase 4	Completed	Toronto Rehabilitation Institute	23	2008-03 → 2012-12
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder NCT00366002	Phase 4	Completed	Novartis	500	2006-06 → 2007-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Darifenacin ER (2024)

Total Spending

$6.7M

Total Claims

37,954

Beneficiaries

10,157

Avg Cost/Unit

$2.98

Spending Trend

$11.8M(2019)→$12.7M(2020)→$12.7M(2021)→$11.9M(2022)→$9.7M(2023)→$6.7M(2024)

YoY Change:-30.8%

5yr CAGR:-11.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs6 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDDARIFENACIN HYDROBROMIDE

DMF 221842008

TAPI NL BVDARIFENACIN HYDROBROMIDE

DMF 222062008

MSN PHARMACHEM PRIVATE LTDDARIFENACIN HYDROBROMIDE [ROUTE CODE -'DF']

DMF 222252008

PH HEALTH LTDDARIFENACIN HYDROBROMIDE (NON STERILE BULK DRUG SUBSTANCE)

DMF 232692009

TORRENT PHARMACEUTICALS LTDDARIFENACIN HYDROBROMIDE

DMF 255302011

ALEMBIC PHARMACEUTICALS LTDDARIFENACIN HYDROBROMIDE

DMF 261382012

MEGAFINE PHARMA P LTDDARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE)

DMF 265332012

JUBILANT BIOSYS LTDDARIFENACIN HYDROBROMIDE

DMF 267192013

EMCURE PHARMACEUTICALS LTDDARIFENACIN HYDROBROMIDE

DMF 268142013

APOTEX INCDARIFENACIN HYDROBROMIDE

DMF 268242013

MACLEODS PHARMACEUTICALS LTDDARIFENACIN HYDROBROMIDE

DMF 270472013

APITORIA PHARMA PRIVATE LTDDARIFENACIN HYDROBROMIDE

DMF 275512013

CIPLA LTDDARIFENACIN HYDROBROMIDE

DMF 280852014

DR REDDYS LABORATORIES LTDInactiveDARIFENACIN HYDROBROMIDE

DMF 220212008

MEDICHEM MANUFACTURING (MALTA) LTDInactiveDARIFENACIN HYDROBROMIDE(MED-200380/M)

DMF 221242008

MYLAN LABORATORIES LTDInactiveDARIFENACIN HYDROBROMIDE

DMF 223712008

INTERQUIM SAInactiveDARIFENACIN HYDROBROMIDE

DMF 230492009

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveDARIFENACIN HYDROBROMIDE

DMF 252822011

UNIMARK REMEDIES LTDInactiveDARIFENACIN HYDROBROMIDE

DMF 264192012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2021	SUPPL -17	View Letter (PDF)
Mar 19, 2012	SUPPL -10	View Letter (PDF)
Jan 18, 2012	SUPPL -8	View Letter (PDF)
Apr 20, 2011	SUPPL -7	View Letter (PDF)
Oct 25, 2010	SUPPL -6	View Letter (PDF)
Dec 19, 2008	SUPPL -5	View Letter (PDF)
Apr 22, 2008	SUPPL -4	View Letter (PDF)
Oct 25, 2005	SUPPL -2	View Letter (PDF)
Dec 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 22, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 22, 2004