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Dapsone - Generic Drug Details

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What are the generic sources for dapsone and what is the scope of dapsone freedom to operate?

Dapsone is the generic ingredient in two branded drugs marketed by Allergan, Allergan Inc, Taro, Actavis Llc, Alvogen, Jacobus, Nostrum Labs Inc, Novitium Pharma, and Virtus Pharms, and is included in ten NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapsone has fifteen patent family members in thirteen countries.

There are eight drug master file entries for dapsone. Sixteen suppliers are listed for this compound.

Summary for dapsone

International Patents:	15
US Patents:	2
Tradenames:	2
Applicants:	9
NDAs:	10
Drug Master File Entries:	8
Suppliers / Packagers:	16
Bulk Api Vendors:	97
Clinical Trials:	78
Patent Applications:	5,626
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapsone
DailyMed Link:	dapsone at DailyMed

Pharmacology for dapsone

Ingredient-type	Sulfones
Drug Class	Sulfone

Medical Subject Heading (MeSH) Categories for dapsone

Anti-Infective Agents

Antimalarials

Folic Acid Antagonists

Leprostatic Agents

Synonyms for dapsone

(4-sulfanilylphenyl)amine

1,1'-Sulfonylbis(4-aminobenzene)

1,1'-Sulfonylbis[4-aminobenzene]

1,1'-Sulphonylbis(4-aminobenzene)

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

1246638-15-2

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

4,4`-DiaminoDiphenylSulphone

4,4-Diaminodifenylsulfon

4,4-Diaminodifenylsulfon [Czech]

4,4-Diaminodiphenyl Sulfone

4,4-Diaminodiphenylsulfone

4,4-Sulfonyldianiline

4,4' Diaminophenyl Sulfone

4,4'-Dapsone

4,4'-DDS

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

AC1L1EUH

AC1Q51WM

AC1Q51WN

ACMC-209piw

ACT07431

Aczone

Aczone (TN)

AI3-08087

AK175100

AKOS000119322

ALBB-005917

Ambap80-08-0

AN-24011

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

BRN 0788055

BSPBio_000129

BSPBio_002129

C07666

CAS-80-08-0

CBDivE_013582

CCG-40260

CCRIS 192

CD0112

CHEBI:4325

CHEMBL1043

CJ-00109

CPD000059064

Croysulfone

Croysulphone

CS-2928

CTK5E7438

D SS

D00592

D0089

D0MA9N

DADPS

Dapsoderm-X

Dapson

Dapson-Fatol

Dapsona

Dapsona [INN-Spanish]

Dapsone (USP)

Dapsone [USAN:BAN]

Dapsone [USAN:USP:INN:BAN]

Dapsone-d8

Dapsone, European Pharmacopoeia (EP) Reference Standard

Dapsone, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Dapsone, United States Pharmacopeia (USP) Reference Standard

Dapsone, VETRANAL(TM), analytical standard

Dapsonum

Dapsonum [INN-Latin]

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

Diamino-diphenyl sulphone

Diaminodifenilsulfona

Diaminodifenilsulfona [Spanish]

Diaminodiphenyl sulfone

Diaminodiphenylsulfone

Dianiline, 4,4'-sulfonyl-

Diaphenyl sulfone

Diaphenylsulfon

Diaphenylsulfone

Diaphenylsulfone (JAN)

diaphenylsulfone;

Diaphenylsulphon

Diaphenylsulphone

Dimitone

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

Fatol Brand of Dapsone

FT-0624447

Hardener HT 976

HMS1568G11

HMS1920C14

HMS2091K04

HMS2095G11

HMS2231G09

HMS3259C13

HMS3369B11

HMS501M15

HSDB 5073

HT 9664

HT 976

HY 976

HY-B0688

I01-3640

IDI1_000573

IN-201

KB-105651

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

Mex-America Brand of Dapsone

MFCD00007887

MLS000069409

MLS001055349

MLS001076146

MolPort-001-780-172

MQJKPEGWNLWLTK-UHFFFAOYSA-N

N, N'-Diphenyl sulfondiamide

N,N'-Diphenyl sulfondiamide

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-756716

NSC6091

NSC756716

Opera_ID_1950

Oprea1_143052

OR020157

OR175241

OR342946

Orsade Brand of Dapsone

p-Aminophenyl sulfone

p, p'-Sulfonyldianiline

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

R1186

RP28805

RTR-025382

s4612

SAM002554879

SBB003168

SBI-0051331.P003

SC-46793

SCHEMBL21428

Servidapson

Slphadione

SMR000059064

SPBio_001025

SPBio_002050

Spectrum_000888

SPECTRUM1500222

Spectrum2_001133

Spectrum3_000375

Spectrum4_000310

Spectrum5_000825

SR-01000002976

SR-01000002976-2

ST50308134

STK387118

Sulfadione

Sulfanona-mae

Sulfon-mere

Sulfona

Sulfona-MAE

Sulfone ucb

Sulfone, 4,4'-Diaminophenyl

Sulfone, diphenyl, 4,4'-diamino-

Sulfonyldianiline

Sulphadione

Sulphon-mere

Sulphonyldianiline

Sumicure S

Tarimyl

TL8005401

Tox21_110371

Tox21_110371_1

Tox21_201347

Tox21_300558

Udolac

UNII-8W5C518302

W R 448

WLN: ZR DSWR DZ

WR 448

ZB000637

ZINC6310

US Patents and Regulatory Information for dapsone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	DAPSONE	dapsone	TABLET;ORAL	206505-002	Dec 1, 2016	AB	RX	No	No
Nostrum Labs Inc	DAPSONE	dapsone	TABLET;ORAL	203887-001	May 6, 2016	AB	RX	No	No
Allergan Inc	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016		RX	Yes	Yes
Alvogen	DAPSONE	dapsone	TABLET;ORAL	205429-001	Jan 7, 2016	AB	RX	No	No

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Expired US Patents for dapsone

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

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International Patents for dapsone

Country	Document Number	Estimated Expiration
Russian Federation	2638815
Mexico	2015006396
Denmark	2922528
Hong Kong	1214516