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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 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, Rising, 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-three patent family members in fifteen countries.

There are eight drug master file entries for dapsone. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dapsone

International Patents:	23
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	13
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	85
Patent Applications:	5,895
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
Pulmonem Inc.	Phase 3
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 3
Hunt Regional Medical Center	Early Phase 1

See all dapsone clinical trials

Generic filers with tentative approvals for DAPSONE

Applicant	Application No.	Strength	Dosage Form
		7.5%	GEL;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	NDA	Submissiondate
ACZONE	GEL;TOPICAL	dapsone	207154	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
Virtus Pharms	DAPSONE	dapsone	TABLET;ORAL	204074-002	May 10, 2016	AB	RX	No	No
Nostrum Labs Inc	DAPSONE	dapsone	TABLET;ORAL	203887-001	May 6, 2016	AB	RX	No	No
Actavis Llc	DAPSONE	dapsone	TABLET;ORAL	204380-001	Mar 23, 2017	AB	RX	No	No
Novitium Pharma	DAPSONE	dapsone	TABLET;ORAL	206505-002	Dec 1, 2016	AB	RX	No	No
Actavis Llc	DAPSONE	dapsone	TABLET;ORAL	204380-002	Mar 23, 2017	AB	RX	No	No

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
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016

International Patents for dapsone

Country	Patent Number	Estimated Expiration
South Korea	20150085069
Spain	2644342
South Korea	20210049968
Mexico	2015006396
Japan	2016500072
Russian Federation	2638815