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Last Updated: June 18, 2021

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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.

DrugPatentWatch® 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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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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005   Try Before You Buy   Try Before You Buy
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016   Try Before You Buy   Try Before You Buy
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005   Try Before You Buy   Try Before You Buy
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005   Try Before You Buy   Try Before You Buy
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016   Try Before You Buy   Try Before You Buy
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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