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Last Updated: September 28, 2020

DrugPatentWatch Database Preview

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, Taro, Taro Pharms, Actavis Llc, Alvogen, Jacobus, Nostrum Labs Inc, Novitium Pharma, Sai Life Sciences, and Virtus Pharms, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapsone has twenty-one patent family members in fifteen countries.

There are eight drug master file entries for dapsone. Fifteen suppliers are listed for this compound.

Drug Prices for dapsone

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Recent Clinical Trials for dapsone

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SponsorPhase
Henry Ford Health SystemN/A
Postgraduate Institute of Dental Sciences RohtakPhase 4
Catawba ResearchPhase 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 NDA Submissiondate
ACZONE GEL;TOPICAL dapsone 207154 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 206505-001 Dec 1, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Nostrum Labs Inc DAPSONE dapsone TABLET;ORAL 203887-001 May 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Taro DAPSONE dapsone GEL;TOPICAL 209506-001 Oct 16, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Taro DAPSONE dapsone TABLET;ORAL 209430-002 Mar 1, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes   Start Trial   Start Trial   Start 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
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016   Start Trial   Start Trial
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005   Start Trial   Start Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016   Start Trial   Start Trial
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005   Start Trial   Start Trial
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Mallinckrodt
Medtronic
McKesson
AstraZeneca

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