DAPSONE - Generic Drug Details

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, Alembic, Amneal, Beloteca, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-three NDAs. There are three patents 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-three suppliers are listed for this compound.

Summary for DAPSONE

International Patents:	23
US Patents:	3
Tradenames:	2
Applicants:	18
NDAs:	23
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	87
Patent Applications:	5,913
Formulation / Manufacturing:	see details
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
Assiut University	Phase 4
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 3
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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes			Y
Alembic	DAPSONE	dapsone	GEL;TOPICAL	215718-001	Oct 27, 2023	AB	RX	No	No
Taro	DAPSONE	dapsone	GEL;TOPICAL	210191-001	Jun 26, 2019	AB	RX	No	No
Rising	DAPSONE	dapsone	TABLET;ORAL	207165-002	Jul 20, 2023	AB	RX	No	No
Chartwell Rx	DAPSONE	dapsone	TABLET;ORAL	204074-001	May 10, 2016		DISCN	No	No
Taro	DAPSONE	dapsone	TABLET;ORAL	209430-001	Mar 1, 2019		DISCN	No	No
Nostrum Labs Inc	DAPSONE	dapsone	TABLET;ORAL	203887-001	May 6, 2016	AB	RX	No	No

Expired US Patents for DAPSONE

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

International Patents for DAPSONE

Country	Patent Number	Title	Estimated Expiration
Hungary	E035940
South Korea	20150085069	국소적 댑손 및 댑손/아다팔렌 조성물 및 이의 사용 방법 (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)
Poland	2922528
Australia	2018214139	Topical dapsone and dapsone/adapalene compositions and methods for use thereof
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)
China	105246457	Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Russian Federation	2638815	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ДАПСОН И ДАПСОН/АДАПАЛЕН, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ (TOPICAL APPLICATION COMPOSITIONS CONTAINING DAPSON AND DAPSONE/ADAPALEN, AND METHODS FOR THEIR APPLICATION)