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.
Summary for ACZONE
International Patents: | 23 |
US Patents: | 3 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 136 |
Clinical Trials: | 15 |
Patent Applications: | 3,880 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ACZONE |
Drug Sales Revenues: | Drug sales revenues for ACZONE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACZONE |
What excipients (inactive ingredients) are in ACZONE? | ACZONE excipients list |
DailyMed Link: | ACZONE at DailyMed |



Recent Clinical Trials for ACZONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Torrent Pharmaceuticals Limited | Phase 3 |
Catawba Research | Phase 3 |
Icahn School of Medicine at Mount Sinai | Phase 4 |
Pharmacology for ACZONE
Drug Class | Sulfone |
Anatomical Therapeutic Chemical (ATC) Classes for ACZONE
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 |