RHOFADE Drug Patent Profile
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When do Rhofade patents expire, and what generic alternatives are available?
Rhofade is a drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-four patent family members in thirteen countries.
The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four 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
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Questions you can ask:
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Summary for RHOFADE
| International Patents: | 24 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,937 |
| 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 |
Recent Clinical Trials for RHOFADE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Actavis Inc. | Phase 3 |
| Teva Pharmaceuticals USA | Phase 3 |
| Candela Corporation | Phase 4 |
Pharmacology for RHOFADE
| Drug Class | Vasoconstrictor |
| Physiological Effect | Increased Sympathetic Activity Vasoconstriction |
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 eight US patents.
Patents protecting RHOFADE
Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM, WHERE THE PATIENT EXPERIENCES NO REBOUND OR WORSENING OF FACIAL ERYTHEMA POST-TREATMENT
Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS
Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN FEMALE ADULTS
Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM
Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM
Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM
Pharmaceutical cream compositions and methods of use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stabilized oxymetazoline formulations and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for RHOFADE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RHOFADE
See the table below for patents covering RHOFADE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | I533893 | ⤷ Sign Up | |
| Spain | 2843696 | ⤷ Sign Up | |
| Canada | 2951725 | FORMULATIONS D'OXYMETAZOLINE STABILISEES ET LEURS UTILISATIONS (STABILIZED OXYMETAZOLINE FORMULATIONS AND THEIR USES) | ⤷ Sign Up |
| Hong Kong | 1190307 | 含有羥甲唑啉的藥物乳膏組合物 (PHARMACEUTICAL CREAM COMPOSITIONS COMPRISING OXYMETAZOLINE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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