RHOFADE Drug Patent Profile

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

Rhofade is a drug marketed by Epi Hlth and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in twelve countries.

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.

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

Summary for RHOFADE

International Patents:	23
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	4
Patent Applications:	2,254
Formulation / Manufacturing:	see details
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

See drug prices for RHOFADE

Recent Clinical Trials for RHOFADE

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

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

See all RHOFADE clinical trials

Pharmacology for RHOFADE

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

Anatomical Therapeutic Chemical (ATC) Classes for RHOFADE

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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 seven US patents.

Patents protecting RHOFADE

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

International Patents for RHOFADE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2014505026
Australia	2016238909	Pharmaceutical cream compositions comprising oxymetazoline
Portugal	2645993
Denmark	2645993
Canada	2819633	COMPOSITIONS DE CREME PHARMACEUTIQUE ET LEURS PROCEDES D'UTILISATION (PHARMACEUTICAL CREAM COMPOSITIONS AND METHODS OF USE)
European Patent Office	2645993	COMPOSITIONS DE CRÈME PHARMACEUTIQUE CONTENANT DE L'OXYMETAZOLINE (PHARMACEUTICAL CREAM COMPOSITIONS COMPRISING OXYMETAZOLINE)