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.
Summary for dapsone
International Patents: | 23 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 14 |
NDAs: | 16 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 144 |
Clinical Trials: | 87 |
Patent Applications: | 5,856 |
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 |
Recent Clinical Trials for dapsone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 4 |
McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 3 |
Pulmonem Inc. | Phase 3 |
Pharmacology for dapsone
Drug Class | Sulfone |
Medical Subject Heading (MeSH) Categories for dapsone
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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