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Last Updated: January 27, 2023

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, Cosette, Mylan, Taro, Taro Pharms, Torrent, Actavis Llc, Alvogen, Anda Repository, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in sixteen 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. Fourteen 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
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 3
Pulmonem Inc.Phase 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
Actavis Llc DAPSONE dapsone TABLET;ORAL 204380-002 Mar 23, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro DAPSONE dapsone TABLET;ORAL 209430-001 Mar 1, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cosette DAPSONE dapsone GEL;TOPICAL 210178-001 Mar 31, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anda Repository DAPSONE dapsone TABLET;ORAL 204074-001 May 10, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 See Plans and Pricing See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 See Plans and Pricing See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 See Plans and Pricing See Plans and Pricing
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 See Plans and Pricing See Plans and Pricing
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dapsone

Country Patent Number Title Estimated Expiration
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) See Plans and Pricing
Mexico 362520 COMPOSICIONES DE DAPSONA Y DAPSONA/ADAPALENO TOPICAS Y METODOS PARA SU USO. (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF.) See Plans and Pricing
Canada 2890224 COMPOSITIONS TOPIQUES DE DAPSONE ET DE DAPSONE/ADAPALENE ET LEURS METHODES D'UTILISATION (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF) See Plans and Pricing
Australia 2018214139 Topical dapsone and dapsone/adapalene compositions and methods for use thereof See Plans and Pricing
Hungary E035940 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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