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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Summary for RHOFADE

International Patents:	24
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	4
Patent Applications:	1,937
Drug Prices:	Drug price information for RHOFADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RHOFADE
What excipients (inactive ingredients) are in RHOFADE?	RHOFADE excipients list
DailyMed Link:	RHOFADE at DailyMed

Drug patent expirations by year for RHOFADE

Recent Clinical Trials for RHOFADE

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

Sponsor	Phase
Actavis Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3
Candela Corporation	Phase 4

See all RHOFADE clinical trials

Pharmacology for RHOFADE

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

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

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

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Glossary

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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

Expired US Patents for RHOFADE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	⤷ Sign Up	⤷ Sign Up
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for RHOFADE

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015191917		⤷ Sign Up
Spain	2618907		⤷ Sign Up
Spain	2843696		⤷ Sign Up
Mexico	2016016400	FORMULACIONES DE OXIMETAZOLINA ESTABILIZADAS Y SUS USOS. (STABILIZED OXYMETAZOLINE FORMULATIONS AND THEIR USES.)	⤷ Sign Up
European Patent Office	3181121	COMPOSITIONS DE CRÈME PHARMACEUTIQUE COMPRENANT DE L'OXYMETAZOLINE POUR TRAITER LA ROSACÉE (PHARMACEUTICAL CREAM COMPOSITIONS COMPRISING OXYMETAZOLINE TO TREAT ROSACEA)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration