Viewing data from:

DARIFENACIN HYDROBROMIDE

ANDA

DARIFENACIN HYDROBROMIDE | A205209 | TORRENT PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.5673

per ea

Lowest NADAC/Unit

$0.4013

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
13668020230DARIFENACIN ER 7.5 MG TABLET	$0.5673	EA	Generic	—	2026-06-17
13668020290DARIFENACIN ER 7.5 MG TABLET	$0.5673	EA	Generic	—	2026-06-17
13668020330DARIFENACIN ER 15 MG TABLET	$0.4013	EA	Generic	—	2026-06-17
13668020390DARIFENACIN ER 15 MG TABLET	$0.4013	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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.

Products (2)

Sort:

#001 — EQ 7.5MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 17, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 15MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 17, 2016