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Generated: October 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207154

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NDA 207154 describes ACZONE, which is a drug marketed by Allergan and Allergan Inc and is included in two NDAs. It is available from two suppliers. There are two patents 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. Fifteen suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 207154
Tradename:ACZONE
Applicant:Allergan Inc
Ingredient:dapsone
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 207154
Ingredient-typeSulfones
Medical Subject Heading (MeSH) Categories for 207154
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 Allergan, Inc. 0023-5206 0023-5206-30 1 BOTTLE, PUMP in 1 CARTON (0023-5206-30) > 30 g in 1 BOTTLE, PUMP
ACZONE dapsone GEL;TOPICAL 207154 NDA Allergan, Inc. 0023-5206 0023-5206-60 1 BOTTLE, PUMP in 1 CARTON (0023-5206-60) > 60 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength7.5%
Approval Date:Feb 24, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 24, 2019
Regulatory Exclusivity Use:NEW STRENGTH
Patent:➤ Sign UpPatent Expiration:Nov 18, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 18, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS

Expired US Patents for NDA 207154

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Inc ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ➤ Sign Up ➤ Sign Up
Allergan Inc ACZONE dapsone GEL;TOPICAL 207154-001 Feb 24, 2016 ➤ Sign Up ➤ Sign Up
Allergan Inc 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

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Daiichi Sankyo

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