ACZONE Drug Patent Profile
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When do Aczone patents expire, and what generic alternatives are available?
Aczone is a drug marketed by Abbvie 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. Twenty-six 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ACZONE?
- What are the global sales for ACZONE?
- What is Average Wholesale Price for ACZONE?
Summary for ACZONE
International Patents: | 23 |
US Patents: | 3 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 15 |
Patent Applications: | 2,505 |
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 |
US Patents and Regulatory Information for ACZONE
ACZONE is protected by three US patents.
Patents protecting ACZONE
Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>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 | 2015006396 | COMPOSICIONES DE DAPSONA Y DAPSONA/ADAPALENO TOPICAS Y METODOS PARA SU USO. (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF.) | ⤷ Sign Up |
Spain | 2644342 | ⤷ Sign Up | |
Hungary | E035940 | ⤷ Sign Up | |
Canada | 2855045 | ⤷ Sign Up | |
European Patent Office | 0957900 | PREPARATIONS ET PROCEDES SERVANT A L'APPLICATION TOPIQUE D'AGENTS THERAPEUTIQUES (COMPOSITIONS AND METHODS FOR TOPICAL APPLICATION OF THERAPEUTIC AGENTS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |