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 Abbvie, Almirall, Acrux Dds, Alembic, Amneal, Beloteca, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapsone has twenty-three patent family members in fifteen countries.

There are eight drug master file entries for dapsone. Twenty-seven suppliers are listed for this compound.

Summary for DAPSONE

International Patents:	23
US Patents:	1
Tradenames:	2
Applicants:	20
NDAs:	25
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	88
Patent Applications:	9,475
Drug Prices:	Drug price trends for DAPSONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAPSONE
What excipients (inactive ingredients) are in DAPSONE?	DAPSONE excipients list
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
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Assiut University	Phase 4
Pulmonem Inc.	Phase 3

See all DAPSONE clinical trials

Pharmacology for DAPSONE

Drug Class	Sulfone

Medical Subject Heading (MeSH) Categories for DAPSONE

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Anatomical Therapeutic Chemical (ATC) Classes for DAPSONE

D10AX	Other anti-acne preparations for topical use
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J04BA	Drugs for treatment of lepra
J04B	DRUGS FOR TREATMENT OF LEPRA
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DAPSONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACZONE	Gel	dapsone	7.5%	207154	1	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
Trupharma	DAPSONE	dapsone	GEL;TOPICAL	213907-001	Jun 6, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	DAPSONE	dapsone	GEL;TOPICAL	214019-001	May 8, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Everest Life Sci	DAPSONE	dapsone	TABLET;ORAL	086841-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	DAPSONE	dapsone	GEL;TOPICAL	215087-001	Oct 31, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs Inc	DAPSONE	dapsone	TABLET;ORAL	203887-002	May 6, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	DAPSONE	dapsone	TABLET;ORAL	207165-002	Jul 20, 2023	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

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

International Patents for DAPSONE

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1214516	局部氨苯碸和氨苯碸/阿達帕林組合物及其使用方法 (TOPICAL DAPSONE AND DAPSONE ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)	⤷ Sign Up
Japan	2016500072	局所用ダプソンおよびダプソン／アダパレン組成物、ならびにその使用方法	⤷ Sign Up
Mexico	2015006396	COMPOSICIONES DE DAPSONA Y DAPSONA/ADAPALENO TOPICAS Y METODOS PARA SU USO. (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF.)	⤷ Sign Up
Russian Federation	2015123207	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ДАПСОН И ДАПСОН/АДАПАЛЕН, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ	⤷ Sign Up
European Patent Office	2922528	COMPOSITIONS TOPIQUES DE DAPSONE ET DE DAPSONE/ADAPALÈNE ET LEURS MÉTHODES D'UTILISATION (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014081674		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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