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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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.5056

per gm

Lowest NADAC/Unit

$0.5056

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00472012645ADAPALENE 0.3% GEL	$0.5056	GM	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$61.99

Highest Price

$61.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00472-0126-45ADAPALENE 0.3% GEL,TOP	$61.99	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain10 active DMFs4 inactive

10 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

ALEMBIC PHARMACEUTICALS LTDADAPALENE USP

DMF 436232026

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.