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Last Updated: October 27, 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
⤷  Try it Free⤷  Try it Free7.5%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
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Virtus Pharms DAPSONE dapsone TABLET;ORAL 204074-002 May 10, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nostrum Labs Inc DAPSONE dapsone TABLET;ORAL 203887-001 May 6, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Llc DAPSONE dapsone TABLET;ORAL 204380-001 Mar 23, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novitium Pharma DAPSONE dapsone TABLET;ORAL 206505-002 Dec 1, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Llc DAPSONE dapsone TABLET;ORAL 204380-002 Mar 23, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ⤷  Try it Free ⤷  Try it Free
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 ⤷  Try it Free ⤷  Try it Free
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ⤷  Try it Free ⤷  Try it Free
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 ⤷  Try it Free ⤷  Try it Free
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ⤷  Try it Free ⤷  Try it Free
>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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