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ACZONE Drug Profile

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Which patents cover Aczone, and what generic alternatives are available?

Aczone is a drug marketed by Allergan and Almirall and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in fifteen countries.

The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dapsone profile page.

US ANDA Litigation and Generic Entry Outlook for Aczone

A generic version of ACZONE was approved as dapsone by NOSTRUM LABS INC on May 6^th, 2016.

Summary for ACZONE

International Patents:	21
US Patents:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	4
Bulk Api Vendors:	118
Clinical Trials:	15
Patent Applications:	6,525
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACZONE
Drug Sales Revenues:	Drug sales revenues for ACZONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACZONE
DailyMed Link:	ACZONE at DailyMed

See drug prices for ACZONE

See drug sales revenues for ACZONE

Recent Clinical Trials for ACZONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Catawba Research	Phase 3
Torrent Pharmaceuticals Limited	Phase 3
Icahn School of Medicine at Mount Sinai	Phase 4

See all ACZONE clinical trials

Recent Litigation for ACZONE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ALMIRALL, LLC v. ZYDUS PHARMACEUTICALS (USA) INC.	2020-01-09
Allergan, Inc. v. Taro Pharmaceuticals, Inc.	2017-07-28
Almirall LLC v. Taro Pharmaceutical Industries Ltd.	2017-06-01

See all ACZONE litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2019-06-07
Amneal Pharmaceuticals LLC	2018-11-06
Amneal Pharmceuticals LLC	2018-02-12

See all ACZONE litigation

Pharmacology for ACZONE

Drug Class

Sulfone

Synonyms for ACZONE

(4-sulfanilylphenyl)amine

1,1'-Sulfonylbis(4-aminobenzene)

1,1'-Sulfonylbis[4-aminobenzene]

1,1'-Sulphonylbis(4-aminobenzene)

1,1''-sulfonylbis(4-aminobenzene)

1358F

4 4-Diamino Diphenyl Sulfone 99.5%min Cas:80-08-8

4 inverted exclamation marka-Diaminodiphenyl sulfone

4 inverted exclamation marka-Sulfonyldianiline

4-(4-amino-benzenesulfonyl)-phenylamine

4-(4-aminobenzenesulfonyl)aniline

4-(4-aminophenyl)sulfonylaniline

4-(4-aminophenylsulfonyl)aniline

4-(4-aminophenylsulfonyl)benzenamine

4-[(4-aminobenzene)sulfonyl]aniline

4-[(4-aminophenyl)sulfonyl]aniline

4-[(4-Aminophenyl)sulfonyl]phenylamine

4-[(4-Aminophenyl)sulfonyl]phenylamine #

4-Aminop henyl sulfone

4-Aminophenyl sulfone

4-Aminophenyl sulfone, 97%

4-Aminophenylsulfone

4,4 inverted exclamation mark(R)-Diaminodiphenyl sulfone

4,4 inverted exclamation mark(R)-Sulfonyldianiline

4,4 inverted exclamation marka-Diaminodiphenyl sulfone

4,4 inverted exclamation marka-Diaminodiphenyl sulfone; 4,4 inverted exclamation marka-Sulfonyldianiline; Bis(4-aminophenyl) sulfone; Dapsone

4,4 inverted exclamation marka-Sulfonyldianiline

4,4-Diaminodifenylsulfon

4,4-Diaminodifenylsulfon [Czech]

4,4-Diaminodiphenyl Sulfone

4,4-Diaminodiphenylsulfone

4,4-Sulfonyldianiline

4,4'-Dapsone

4,4'-DDS

4,4'-diamino diphenyl sulfone

4,4'-diamino diphenyl sulphone

4,4'-Diaminodiphenyl sulfone

4,4'-Diaminodiphenyl sulphone

4,4'-Diaminodiphenyl suphone

4,4'-Diaminodiphenylsulfone

4,4'-diaminophenyl sulfone

4,4'-Sulfonylbis-benzenamine

4,4'-Sulfonylbis[benzamine]

4,4'-Sulfonylbisaniline

4,4'-Sulfonylbisbenzamine

4,4'-Sulfonylbisbenzenamine

4,4'-Sulfonylbisbenzeneamine

4,4'-Sulfonyldianilin

4,4'-Sulfonyldianiline

4,4'-Sulfonyldianiline (Dapsone)

4,4'-Sulfonyldiphenylamine

4,4'-Sulphonylbisbenzamine

4,4'-Sulphonylbisbenzenamine

4,4'-Sulphonyldianiline

4,4''-dapsone

4,4''-diaminodiphenyl sulfone

4,4''-sulfonylbisaniline

4,4''-Sulfonylbisbenzenamine

4,4''-sulfonyldianiline

4'-Diaminodiphenyl sulfone

80-08-0

8W5C518302

A839828

AB00051962

AB00051962_19

AB1004833

AC-10922

ACMC-209piw

ACT07431

Aczone (TN)

AI3-08087

AK175100

AKOS000119322

ALBB-005917

Aniline, 4,4'-sulfonyldi-

Aniline,4'-sulfonyldi-

ANW-37350

Araldite HT

Araldite HT 976

Atrisone

Avlosulfon

Avlosulfone

Avlosulphone

Avsulfor

AZT + Dapsone cominbation

BBL002412

BDBM50029764

Benzenamine, 4,4'-sulfonylbis-

Benzenamine,4'-sulfonylbis-

BIDD:GT0770

BIS SULFONE

Bis(4-aminophenyl) sulfone

Bis(4-aminophenyl)sulfone

Bis(4-aminophenyl)sulphone

Bis(p-aminophenyl) sulfone

Bis(p-aminophenyl)sulphone

BPBio1_000143

BRD-K62363391-001-05-8

BRD-K62363391-001-15-7

BRN 0788055

BSPBio_000129

BSPBio_002129

C07666

CAS-80-08-0

CBDivE_013582

CCG-40260

CCRIS 192

CD0112

CHEBI:4325

CHEMBL1043

CPD000059064

Croysulfone

Croysulphone

CS-2928

CTK5E7438

D SS

D00592

D0089

DADPS

Dapson

Dapsona

Dapsona [INN-Spanish]

dapsone

Dapsone (USP)

Dapsone [USAN:BAN]

Dapsone [USAN:USP:INN:BAN]

Dapsone-d8

Dapsone, British Pharmacopoeia (BP) Reference Standard

Dapsone, European Pharmacopoeia (EP) Reference Standard

Dapsone, Pharmaceutical Secondary Standard; Certified Reference Material

Dapsone, United States Pharmacopeia (USP) Reference Standard

Dapsone, VETRANAL(TM), analytical standard

Dapsone,(S)

Dapsonum

Dapsonum [INN-Latin]

DB-056406

DB00250

DDS

DDS (pharmaceutical)

DDS, diaphenylsulfone

DDS, pharmaceutical

Di(4-aminophenyl) sulfone

Di(4-aminophenyl)sulfone

Di(4-aminophenyl)sulphone

Di(p-aminophenyl) sulfone

Di(p-aminophenyl)sulphone

Diamino-4,4'-diphenyl sulfone

Diamino-4,4'-diphenyl sulphone

Diaminodifenilsulfona

Diaminodifenilsulfona [Spanish]

Diaminodiphenyl sulfone

Diaminodiphenylsulfone

Dianiline, 4,4'-sulfonyl-

Diaphenyl sulfone

Diaphenylsulfon

Diaphenylsulfone

Diaphenylsulfone (JAN)

diaphenylsulfone;

Diaphenylsulphon

Diaphenylsulphone

Diphenasone

Diphone

Disulone

DivK1c_000573

DSS (VAN)

DSSTox_CID_371

DSSTox_GSID_20371

DSSTox_RID_75547

DTXSID4020371

Dubronax

Dubronaz

Dumitone

EBD28910

EC 201-248-4

EINECS 201-248-4

Eporal

F 1358

F0266-3067

FT-0624447

Hardener HT 976

HMS1568G11

HMS1920C14

HMS2091K04

HMS2095G11

HMS2231G09

HMS3259C13

HMS3369B11

HMS3712G11

HMS501M15

HSDB 5073

HT 9664

HT 976

HY 976

HY-B0688

ICI

IDI1_000573

IN-201

J04BA02

KBio1_000573

KBio2_001368

KBio2_003936

KBio2_006504

KBio3_001349

KBioGR_000900

KBioSS_001368

KS-00000JP1

KS-1450

KSC647I3R

LS-1790

LS10738

MCULE-7294380437

Metabolite C

MFCD00007887

MLS000069409

MLS001055349

MLS001076146

MQJKPEGWNLWLTK-UHFFFAOYSA-N

N,N'-Diphenyl sulfondiamide

NC00488

NCGC00016322-01

NCGC00016322-02

NCGC00016322-03

NCGC00016322-04

NCGC00016322-05

NCGC00016322-06

NCGC00016322-07

NCGC00016322-08

NCGC00016322-09

NCGC00016322-10

NCGC00016322-13

NCGC00023946-03

NCGC00023946-04

NCGC00023946-05

NCGC00023946-06

NCGC00254533-01

NCGC00258899-01

NCI-C01718

NINDS_000573

Novophone

NSC 6091

NSC 6091D

NSC-6091

NSC-6091D

NSC-756716

NSC6091

NSC756716

Opera_ID_1950

Oprea1_143052

p-Aminophenyl sulfone

p,p-Diaminodiphenyl sulphone

p,p-Sulfonylbisbenzamine

p,p-Sulfonylbisbenzenamine

p,p-Sulphonylbisbenzamine

p,p-Sulphonylbisbenzenamine

p,p-Sulphonyldianiline

p,p'-Diaminodiphenyl sulfone

p,p'-sulfonyldianiline

p,p''-diaminodiphenyl sulfone

Pharmakon1600-01500222

Prestwick_152

Prestwick0_000035

Prestwick1_000035

Prestwick2_000035

Prestwick3_000035

Protogen

Q-200435

Q422226

R1186

RTR-025382

s4612

SAM002554879

SBB003168

SBI-0051331.P003

SC-46793

SCHEMBL21428

Servidapson

SMR000059064

SPBio_001025

SPBio_002050

Spectrum_000888

SPECTRUM1500222

Spectrum2_001133

Spectrum3_000375

Spectrum4_000310

Spectrum5_000825

SR-01000002976

SR-01000002976-2

SR-01000002976-4

ST50308134

STK387118

Sulfadione

Sulfanona-mae

Sulfon-mere

Sulfona

Sulfona-MAE

Sulfone ucb

Sulfone, diphenyl, 4,4'-diamino-

Sulfonyldianiline

Sulphadione

Sulphon-mere

Sulphonyldianiline

Sumicure S

Tarimyl

Tox21_110371

Tox21_110371_1

Tox21_201347

Tox21_300558

Udolac

UNII-8W5C518302

W R 448

WLN: ZR DSWR DZ

WR 448

ZINC6310

Paragraph IV (Patent) Challenges for ACZONE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ACZONE	GEL;TOPICAL	dapsone	207154	2017-02-13

US Patents and Regulatory Information for ACZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	AB	RX	Yes	Yes
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016		RX	Yes	Yes
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016		RX	Yes	Yes			Y
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016		RX	Yes	Yes

Expired US Patents for ACZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016

International Patents for ACZONE

Country	Patent Number	Estimated Expiration
Spain	2280629
Spain	2644342
Iceland	7419
Portugal	1485059