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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cerilliant
Cantor Fitzgerald
Moodys
Federal Trade Commission
Colorcon
Chubb
Deloitte
McKinsey

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022320

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NDA 022320 describes EPIDUO, which is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. It is available from three suppliers. There are sixteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the EPIDUO profile page.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 022320
Tradename:EPIDUO
Applicant:Galderma Labs Lp
Ingredient:adapalene; benzoyl peroxide
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 022320
Ingredient-typeRetinoids
Suppliers and Packaging for NDA: 022320
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320 NDA Galderma Laboratories, L.P. 0299-5908 N 0299-5908-00
EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320 NDA Galderma Laboratories, L.P. 0299-5908 N 0299-5908-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%;2.5%
Approval Date:Dec 8, 2008TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 23, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ Try a Free TrialPatent Expiration:Jul 18, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 022320

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
McKinsey
Harvard Business School
Teva
Colorcon
Cerilliant
Johnson and Johnson
UBS
Chubb

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