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Last Updated: June 14, 2021

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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

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Drug patent expirations by year for RHOFADE
Drug Prices for RHOFADE

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for RHOFADE
Generic Entry Date for RHOFADE*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all RHOFADE clinical trials

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Harvard Business School
Dow
Express Scripts
McKinsey

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