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

Summary for DAPSONE

International Patents:	23
US Patents:	3
Tradenames:	2
Applicants:	19
NDAs:	24
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	88
Patent Applications:	9,475
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
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Assiut University	Phase 4
McGill University Health Centre/Research Institute of the McGill University Health Centre	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
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	DAPSONE	dapsone	TABLET;ORAL	209430-002	Mar 1, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	DAPSONE	dapsone	TABLET;ORAL	209430-001	Mar 1, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	DAPSONE	dapsone	GEL;TOPICAL	213847-001	Feb 4, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Llc	DAPSONE	dapsone	TABLET;ORAL	204380-001	Mar 23, 2017	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
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
>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
Australia	2018214139	Topical dapsone and dapsone/adapalene compositions and methods for use thereof	⤷ 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
Japan	6285946		⤷ Sign Up
Japan	6644817		⤷ Sign Up
Poland	2922528		⤷ Sign Up
>Country	>Patent Number	>Title	>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.