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Last Updated: August 13, 2022

ACZONE Drug Patent 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 three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Thirteen 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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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

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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 Strength NDA ANDAs Submitted Submissiondate
ACZONE Gel dapsone 7.5% 207154 1 2017-02-13

US Patents and Regulatory Information for ACZONE

ACZONE is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting ACZONE

Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS

FDA Regulatory Exclusivity protecting ACZONE

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 See Plans and Pricing See Plans and Pricing
Allergan ACZONE dapsone GEL;TOPICAL 021794-001 Jul 7, 2005 See Plans and Pricing See Plans and Pricing
Almirall ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ACZONE

See the table below for patents covering ACZONE around the world.

Country Patent Number Title Estimated Expiration
Mexico 362520 COMPOSICIONES DE DAPSONA Y DAPSONA/ADAPALENO TOPICAS Y METODOS PARA SU USO. (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF.) See Plans and Pricing
Denmark 1485059 See Plans and Pricing
Portugal 957900 See Plans and Pricing
Germany 60218227 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.