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Last Updated: August 6, 2020

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ACZONE Drug Profile

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

Aczone is a drug marketed by Allergan and Almirall and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in fifteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Aczone

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

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Drug patent expirations by year for ACZONE
Drug Prices for ACZONE

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Drug Sales Revenue Trends for ACZONE

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Recent Clinical Trials for ACZONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Torrent Pharmaceuticals LimitedPhase 3
Catawba ResearchPhase 3
Icahn School of Medicine at Mount SinaiPhase 4

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Pharmacology for ACZONE
Drug ClassSulfone
Paragraph IV (Patent) Challenges for ACZONE
Tradename Dosage Ingredient NDA Submissiondate
ACZONE GEL;TOPICAL dapsone 207154 2017-02-13

US Patents and Regulatory Information for ACZONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 RX Yes Yes   Start Trial   Start Trial Y   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 ACZONE

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
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
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016   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:

Dow
Johnson and Johnson
Merck
Harvard Business School
Medtronic
AstraZeneca

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