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Last Updated: April 8, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208552


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NDA 208552 describes RHOFADE, which is a drug marketed by Epi Hlth and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the RHOFADE profile page.

The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 208552
Tradename:RHOFADE
Applicant:Epi Hlth
Ingredient:oxymetazoline hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 208552
Medical Subject Heading (MeSH) Categories for 208552
Suppliers and Packaging for NDA: 208552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA Allergan, Inc. 0023-5300 0023-5300-30 1 TUBE in 1 CARTON (0023-5300-30) > 30 g in 1 TUBE
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA Allergan, Inc. 0023-5300 0023-5300-35 1 BOTTLE, PUMP in 1 CARTON (0023-5300-35) > 30 g in 1 BOTTLE, PUMP
Paragraph IV (Patent) Challenges for 208552
Tradename Dosage Ingredient NDA Submissiondate
RHOFADE CREAM;TOPICAL oxymetazoline hydrochloride 208552 2019-06-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Jan 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 18, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jun 11, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM, WHERE THE PATIENT EXPERIENCES NO REBOUND OR WORSENING OF FACIAL ERYTHEMA POST-TREATMENT
Patent:  Start TrialPatent Expiration:May 2, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

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