ACZONE Drug Patent Profile
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Which patents cover Aczone, 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-three 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: | 151 |
Clinical Trials: | 15 |
Patent Applications: | 2,494 |
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.
Patents protecting ACZONE
Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
South Korea | 20040085214 | ⤷ Try a Trial | |
Hong Kong | 1214516 | 局部氨苯碸和氨苯碸/阿達帕林組合物及其使用方法 (TOPICAL DAPSONE AND DAPSONE ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF) | ⤷ Try a Trial |
Spain | 2644342 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |