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Last Updated: October 28, 2021

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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, Rising, 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-three patent family members in fifteen countries.

There are eight drug master file entries for dapsone. Fourteen suppliers are listed for this compound. There is one tentative approval 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
Pulmonem Inc.Phase 3
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 3
Hunt Regional Medical CenterEarly Phase 1

See all DAPSONE clinical trials

Generic filers with tentative approvals for DAPSONE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial7.5%GEL;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Nostrum Labs Inc DAPSONE dapsone TABLET;ORAL 203887-001 May 6, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro DAPSONE dapsone TABLET;ORAL 209430-001 Mar 1, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro DAPSONE dapsone TABLET;ORAL 209430-002 Mar 1, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novitium Pharma DAPSONE dapsone TABLET;ORAL 206505-001 Dec 1, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Johnson and Johnson
McKesson
Mallinckrodt
Merck

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