Dapsone - Generic Drug Details

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

Dapsone is the generic ingredient in two branded drugs marketed by Allergan, Almirall, Taro, Taro Pharms, Actavis Llc, Alvogen, Jacobus, Nostrum Labs Inc, Novitium Pharma, Sai Life Sciences, and Virtus Pharms, and is included in thirteen 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 twenty patent family members in fifteen countries.

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

Summary for dapsone

International Patents:	20
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	13
Drug Master File Entries:	8
Suppliers / Packagers:	16
Bulk Api Vendors:	113
Clinical Trials:	80
Patent Applications:	5,768
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for dapsone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapsone
DailyMed Link:	dapsone at DailyMed

See drug prices for dapsone

Recent Clinical Trials for dapsone

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 dapsone clinical trials

Recent Litigation for dapsone

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Allergan, Inc. v. Taro Pharmaceuticals, Inc.	2017-07-28
Almirall LLC v. Taro Pharmaceutical Industries Ltd.	2017-06-01
Allergan, Inc. v. Taro Pharmaceutical Industries Ltd.

See all dapsone 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 dapsone litigation

Pharmacology for dapsone

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-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 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
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
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
CJ-00109
CPD000059064
Croysulfone
Croysulphone
CS-2928
CTK5E7438
D SS
D00592
D0089
DADPS
Dapson
Dapsona
Dapsona [INN-Spanish]
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]
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
FT-0624447
Hardener HT 976
HMS1568G11
HMS1920C14
HMS2091K04
HMS2095G11
HMS2231G09
HMS3259C13
HMS3369B11
HMS3712G11
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
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
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
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
TL8005401
Tox21_110371
Tox21_110371_1
Tox21_201347
Tox21_300558
Udolac
UNII-8W5C518302
W R 448
WLN: ZR DSWR DZ
WR 448
ZB000637
ZINC6310

Paragraph IV (Patent) Challenges for DAPSONE

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

US Patents and Regulatory Information for dapsone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	DAPSONE	dapsone	TABLET;ORAL	209430-002	Mar 1, 2019		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sai Life Sciences	DAPSONE	dapsone	TABLET;ORAL	207165-001	May 8, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Virtus Pharms	DAPSONE	dapsone	TABLET;ORAL	204074-002	May 10, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Taro	DAPSONE	dapsone	TABLET;ORAL	209430-001	Mar 1, 2019		DISCN	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for dapsone

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

International Patents for dapsone

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Country	Patent Number	Estimated Expiration
Poland	2922528	Start Trial
Mexico	2015006396	Start Trial
Russian Federation	2638815	Start Trial
Canada	2890224	Start Trial
World Intellectual Property Organization (WIPO)	2014081674	Start Trial
Brazil	112015011673	Start Trial
>Country	>Patent Number	>Estimated Expiration

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