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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Darifenacin ER (2023)

Total Spending

$9.7M

Total Claims

37,948

Beneficiaries

9,984

Avg Cost/Unit

$4.30

Spending Trend

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

YoY Change:-9.6%

5yr CAGR:-5.3%

Source: CMS Medicare Part D Spending by Drug (2023). 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