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Dapsone - Generic Drug Details
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, Aqua Pharms Llc, 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.There are eight drug master file entries for dapsone. Fifteen suppliers are listed for this compound.
Summary for dapsone
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 10 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 15 |
| Bulk Api Vendors: | 98 |
| Clinical Trials: | 78 |
| Patent Applications: | 5,625 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for dapsone |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | DAPSONE | dapsone | GEL;TOPICAL | 209506-001 | Oct 16, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Novitium Pharma | DAPSONE | dapsone | TABLET;ORAL | 206505-002 | Dec 1, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Aqua Pharms Llc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Virtus Pharms | DAPSONE | dapsone | TABLET;ORAL | 204074-002 | May 10, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Virtus Pharms | DAPSONE | dapsone | TABLET;ORAL | 204074-001 | May 10, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ➤ Sign Up | ➤ Sign Up |
| Aqua Pharms Llc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ➤ Sign Up | ➤ Sign Up |
| Aqua Pharms Llc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ➤ Sign Up | ➤ Sign Up |
| Aqua Pharms Llc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ➤ Sign Up | ➤ Sign Up |
| Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for dapsone
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2922528 | ➤ Sign Up |
| Russian Federation | 2638815 | ➤ Sign Up |
| China | 105246457 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014081674 | ➤ Sign Up |
| Hong Kong | 1214516 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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