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 is one patent 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-seven 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.

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Summary for ACZONE

International Patents:	23
US Patents:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	15
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

Drug patent expirations by year 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

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 one US patents.

Patents protecting ACZONE

Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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.

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Country	Patent Number	Title	Estimated Expiration
China	105246457	Topical dapsone and dapsone/adapalene compositions and methods for use thereof	⤷ Sign Up
Canada	2477217	APPLICATION TOPIQUE DE DAPSONE POUR TRAITER L'ACNE (TOPICAL DAPSONE FOR THE TREATMENT OF ACNE)	⤷ Sign Up
Slovenia	1485059		⤷ Sign Up
South Korea	20210049968	국소적 댑손 및 댑손/아다팔렌 조성물 및 이의 사용 방법 (/ TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration