ACZONE Drug Patent Profile

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 6^th, 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

See drug prices for ACZONE

See drug sales revenues for ACZONE

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

See all ACZONE clinical trials

Pharmacology for ACZONE

Drug Class

Sulfone

Anatomical Therapeutic Chemical (ATC) Classes for ACZONE

D10AX	Other anti-acne preparations for topical use
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J04BA	Drugs for treatment of lepra
J04B	DRUGS FOR TREATMENT OF LEPRA
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ACZONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACZONE	Gel	dapsone	7.5%	207154	1	2017-02-13

US Patents and Regulatory Information for ACZONE

ACZONE is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting ACZONE

FDA Regulatory Exclusivity protecting 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
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes			Y
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes			Y

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
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016

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.)
Denmark	1485059
Portugal	957900
Germany	60218227