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Last Updated: March 19, 2024

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, 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.

Drug Prices for dapsone

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Recent Clinical Trials for dapsone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPhase 4
Pulmonem Inc.Phase 3
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 3

See all dapsone clinical trials

Pharmacology for dapsone
Drug ClassSulfone
Medical Subject Heading (MeSH) Categories for dapsone
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
Novitium Pharma DAPSONE dapsone TABLET;ORAL 206505-002 Dec 1, 2016 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Encube DAPSONE dapsone GEL;TOPICAL 212383-001 Oct 13, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette DAPSONE dapsone GEL;TOPICAL 210178-001 Mar 31, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx DAPSONE dapsone TABLET;ORAL 204074-001 May 10, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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

International Patents for dapsone

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2014081674 ⤷  Try a Trial
Denmark 2922528 ⤷  Try a Trial
South Korea 20150085069 국소적 댑손 및 댑손/아다팔렌 조성물 및 이의 사용 방법 (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF) ⤷  Try a Trial
China 105246457 Topical dapsone and dapsone/adapalene compositions and methods for use thereof ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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