Rhofade Patent Expiration

Rhofade is a drug owned by Mayne Pharma Llc. It is protected by 8 US drug patents filed from 2017 to 2022. Out of these, 6 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 11, 2035. Details of Rhofade's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11517560 Stabilized oxymetazoline formulations and their uses
Jun, 2035

(10 years from now)

Active
US9974773 Stabilized oxymetazoline formulations and their uses
Jun, 2035

(10 years from now)

Active
US10751325 Stabilized oxymetazoline formulations and their uses
Jun, 2035

(10 years from now)

Active
US10335391 Stabilized oxymetazoline formulations and their uses
Jun, 2035

(10 years from now)

Active
US8883838 Pharmaceutical cream compositions and methods of use
Dec, 2031

(7 years from now)

Active
US7812049 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using α1-adrenoceptor agonists
May, 2028

(3 years from now)

Active
US8420688 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using α1-adrenoceptor agonists
Aug, 2024

(2 months ago)

Expired
US8815929 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using α1-adrenoceptor agonists
Jan, 2024

(8 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rhofade's patents.

Given below is the list of recent legal activities going on the following patents of Rhofade.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 26 Feb, 2024 US10751325
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 11 Jan, 2023 US11517560
Payment of Maintenance Fee, 4th Yr, Small Entity 03 Jan, 2023 US10335391
Email Notification 19 Dec, 2022 US11517560
Change in Power of Attorney (May Include Associate POA) 19 Dec, 2022 US11517560
Correspondence Address Change 14 Dec, 2022 US11517560
Recordation of Patent Grant Mailed 06 Dec, 2022 US11517560
Patent Issue Date Used in PTA Calculation 06 Dec, 2022 US11517560
Email Notification 17 Nov, 2022 US11517560
Issue Notification Mailed 16 Nov, 2022 US11517560


FDA has granted several exclusivities to Rhofade. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rhofade, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rhofade.

Exclusivity Information

Rhofade holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Rhofade's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jan 18, 2020

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US patents provide insights into the exclusivity only within the United States, but Rhofade is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rhofade's family patents as well as insights into ongoing legal events on those patents.

Rhofade's Family Patents

Rhofade has patent protection in a total of 12 countries. It has a significant patent presence in the US with 57.8% of its patents being US patents. Click below to unlock the full patent family tree for Rhofade.

Family Patents

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Generic Launch

Generic Release Date:

Rhofade's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 11, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Rhofade Generics:

Oxymetazoline Hydrochloride is the generic name for the brand Rhofade. 1 company has already filed for the generic of Rhofade. Check out the entire list of companies who have already received approval for Rhofade's generic

How can I launch a generic of Rhofade before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Rhofade's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rhofade's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Rhofade -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.01 20 Jun, 2019 1 04 Oct, 2021 11 Jun, 2035 Eligible

Alternative Brands for Rhofade

Rhofade which is used for reducing persistent facial redness associated with rosacea in adult patients., has several other brand drugs using the same active ingredient (Oxymetazoline Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Rvl Pharms
Upneeq
St Renatus
Kovanaze


Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxymetazoline Hydrochloride, Rhofade's active ingredient. Check the complete list of approved generic manufacturers for Rhofade





About Rhofade

Rhofade is a drug owned by Mayne Pharma Llc. It is used for reducing persistent facial redness associated with rosacea in adult patients. Rhofade uses Oxymetazoline Hydrochloride as an active ingredient. Rhofade was launched by Mayne Pharma in 2017.

Approval Date:

Rhofade was approved by FDA for market use on 18 January, 2017.

Active Ingredient:

Rhofade uses Oxymetazoline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Oxymetazoline Hydrochloride ingredient

Treatment:

Rhofade is used for reducing persistent facial redness associated with rosacea in adult patients.

Dosage:

Rhofade is available in cream form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
1% CREAM Prescription TOPICAL