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 | |||
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
| Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ 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 |
|---|---|---|---|
| Brazil | 0215606 | ⤷ Try a Trial | |
| South Korea | 100864129 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2014081674 | ⤷ Try a Trial | |
| Japan | 6285946 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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