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RHOFADE Drug Profile
» See Plans and Pricing
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
Summary for RHOFADE
| International Patents: | 21 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,052 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RHOFADE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RHOFADE |
| DailyMed Link: | RHOFADE at DailyMed |
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 |
Pharmacology for RHOFADE
| Drug Class | Vasoconstrictor |
| Physiological Effect | Vasoconstriction Increased Sympathetic Activity |
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 |
International Patents for RHOFADE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6030067 | Start Trial |
| Australia | 2015274532 | Start Trial |
| Australia | 2011336449 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
