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Last Updated: September 28, 2020

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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, 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-one patent family members in fifteen countries.

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

Summary for dapsone

International Patents:	21
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	13
Drug Master File Entries:	8
Suppliers / Packagers:	15
Bulk Api Vendors:	122
Clinical Trials:	82
Patent Applications:	5,344
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

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Recent Clinical Trials for dapsone

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Sponsor	Phase
Henry Ford Health System	N/A
Postgraduate Institute of Dental Sciences Rohtak	Phase 4
Catawba Research	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	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
Novitium Pharma	DAPSONE	dapsone	TABLET;ORAL	206505-001	Dec 1, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Nostrum Labs Inc	DAPSONE	dapsone	TABLET;ORAL	203887-001	May 6, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Taro	DAPSONE	dapsone	GEL;TOPICAL	209506-001	Oct 16, 2017	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Taro	DAPSONE	dapsone	TABLET;ORAL	209430-002	Mar 1, 2019		DISCN	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
>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	Start Trial	Start Trial
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
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
Japan	2018083847	Start Trial
Hungary	E035940	Start Trial
Canada	2890224	Start Trial
Russian Federation	2015123207	Start Trial
Russian Federation	2638815	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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