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Last Updated: July 16, 2024

DAPSONE Drug Patent Profile


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Which patents cover Dapsone, and what generic alternatives are available?

Dapsone is a drug marketed by 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-two NDAs.

The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the dapsone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dapsone

A generic version of DAPSONE was approved as dapsone by NOSTRUM LABS INC on May 6th, 2016.

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Drug patent expirations by year for DAPSONE
Drug Prices for DAPSONE

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Recent Clinical Trials for DAPSONE

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SponsorPhase
All India Institute of Medical Sciences, BhubaneswarPhase 4
Assiut UniversityPhase 4
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
Taro DAPSONE dapsone TABLET;ORAL 209430-001 Mar 1, 2019 DISCN No No ⤷  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
Alembic DAPSONE dapsone GEL;TOPICAL 215718-001 Oct 27, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx DAPSONE dapsone TABLET;ORAL 204074-001 May 10, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma DAPSONE dapsone TABLET;ORAL 206505-001 Dec 1, 2016 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

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