You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

Details for New Drug Application (NDA): 207154

✉ Email this page to a colleague

NDA 207154 describes ACZONE, which is a drug marketed by Almirall and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ACZONE profile page.

The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 207154

Tradename:	ACZONE
Applicant:	Almirall
Ingredient:	dapsone
Patents:	1

Pharmacology for NDA: 207154

Medical Subject Heading (MeSH) Categories for 207154

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 207154

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACZONE	dapsone	GEL;TOPICAL	207154	NDA	Almirall, LLC	16110-526	16110-526-60	1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMP
ACZONE	dapsone	GEL;TOPICAL	207154	NDA	Almirall, LLC	16110-526	16110-526-90	1 BOTTLE, PUMP in 1 CARTON (16110-526-90) / 90 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	7.5%
Approval Date:	Feb 24, 2016	TE:	AB	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 207154

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	⤷ Get Started Free	⤷ Get Started Free
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	⤷ Get Started Free	⤷ Get Started Free
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.