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Last Updated: November 25, 2024

RHOFADE Drug Patent Profile


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Which patents cover Rhofade, and when can generic versions of Rhofade launch?

Rhofade is a drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Rhofade

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for RHOFADE
Drug Prices for RHOFADE

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Recent Clinical Trials for RHOFADE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Actavis Inc.Phase 3
Teva Pharmaceuticals USAPhase 3
Candela CorporationPhase 4

See all RHOFADE clinical trials

Pharmacology for RHOFADE
Paragraph IV (Patent) Challenges for RHOFADE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RHOFADE Topical Cream oxymetazoline hydrochloride 1% 208552 1 2019-06-20

US Patents and Regulatory Information for RHOFADE

RHOFADE is protected by eight US patents.

Patents protecting RHOFADE

Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS

Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN FEMALE ADULTS

Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

Pharmaceutical cream compositions and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for RHOFADE

See the table below for patents covering RHOFADE around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2012075319 ⤷  Sign Up
European Patent Office 3154517 ⤷  Sign Up
Canada 2951725 FORMULATIONS D'OXYMETAZOLINE STABILISEES ET LEURS UTILISATIONS (STABILIZED OXYMETAZOLINE FORMULATIONS AND THEIR USES) ⤷  Sign Up
New Zealand 727233 Stabilized oxymetazoline formulations and their uses ⤷  Sign Up
New Zealand 727233 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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