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RHOFADE Drug Profile

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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-two patent family members in twelve countries.

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

DrugPatentWatch^® Generic Entry Outlook for Rhofade

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 22, 2024. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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:	22
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	1,087
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for RHOFADE

NDA:

208552

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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	Vasoconstriction Increased Sympathetic Activity

ATC Classes for RHOFADE

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	NDA	Submissiondate
RHOFADE	CREAM;TOPICAL	oxymetazoline hydrochloride	208552	2019-06-20

US Patents and Regulatory Information for 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

Country	Patent Number	Estimated Expiration
Poland	2645993
European Patent Office	2645993
Denmark	2645993
World Intellectual Property Organization (WIPO)	2012075319
Portugal	2645993
Japan	2014505026