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
(3 months ago) |
Expired
|
| US8815929 | Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using α1-adrenoceptor agonists |
Jan, 2024
(9 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 19 Dec, 2022 | US11517560 |
| Change in Power of Attorney (May Include Associate POA) Critical | 19 Dec, 2022 | US11517560 |
| Correspondence Address Change Critical | 14 Dec, 2022 | US11517560 |
| Recordation of Patent Grant Mailed Critical | 06 Dec, 2022 | US11517560 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Dec, 2022 | US11517560 |
| Email Notification Critical | 17 Nov, 2022 | US11517560 |
| Issue Notification Mailed Critical | 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
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 |