DrugPatentWatch Database Preview
ACZONE Drug 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 two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-one patent family members in fifteen countries.
The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Fifteen 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: | 21 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 132 |
| Clinical Trials: | 15 |
| Patent Applications: | 3,712 |
| 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
| 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 | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | AB | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | ||
| >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 |
|---|---|---|---|---|---|---|---|
| Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | Try Before You Buy | Try Before You Buy |
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | Try Before You Buy | Try Before You Buy |
| Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | Try Before You Buy | Try Before You Buy |
| Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | Try Before You Buy | Try Before You Buy |
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | Try Before You Buy | Try Before You Buy |
| Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACZONE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1214516 | Try Before You Buy |
| Hungary | E035940 | Try Before You Buy |
| Iceland | 2454 | Try Before You Buy |
| Brazil | 112015011673 | Try Before You Buy |
| Mexico | 2015006396 | Try Before You Buy |
| Denmark | 2922528 | Try Before You Buy |
| Australia | 2018214139 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
