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ADAPALENE

ANDA

ADAPALENE | A201000 | ACTAVIS MID ATLANTIC LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DIFFERIN(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Galderma Laboratories LP et al v. Actavis Mid Atlantic LLC 1:2010cv00887 2 patentsANDA 2010006-[3-(1-adamantyl)-4methoxyphenyl]-2-naphthoic acid (adapalene)	D. Del.	2010-10-15	Terminated 2012-10-25	—

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

API Supply Chain9 active DMFs4 inactive

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

FINORGA SASADAPALENE

DMF 87841990

ALIVUS LIFE SCIENCES LTDADAPALENE USP

DMF 187562005

HAS HEALTHCARE ADVANCED SYNTHESIS SAADAPALENE

DMF 188262005

EXCELLA GMBH AND CO KGADAPALENE

DMF 191692006

OLON SPAADAPALENE DRUG SUBSTANCE

DMF 196212006

TARO PHARMACEUTICAL INDUSTRIES LTDADAPALENE USP, MICRONIZED

DMF 212082008

MEDICHEM SAADAPALENE (MED-200025/E)

DMF 214802008

AARTI PHARMALABS LTDADAPALENE

DMF 227092009

MAITHRI DRUGS PRIVATE LTDADAPALENE USP

DMF 390632023

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTDInactiveADAPALENE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 188312005

ZYDUS LIFESCIENCES LTDInactiveADAPALENE USP

DMF 200642006

AMINO CHEMICALS LTDInactiveADAPALENE

DMF 201062006

ALP PHARM BEIJING CO LTDInactiveADAPALENE (DRUG SUBTANCE NON-STERILE)

DMF 235362010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 29, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Oct 27, 2014

No patent or exclusivity listings for this strength.