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Last Updated: August 12, 2020

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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 six patents protecting this drug.

This drug has twenty-one 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.

US ANDA Litigation and Generic Entry Outlook for Rhofade

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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Recent Clinical Trials for RHOFADE

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

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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   Start Trial   Start Trial   Start Trial
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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