Epsolay is a drug owned by Mayne Pharma Llc. It is protected by 14 US drug patents filed from 2022 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 23, 2041. Details of Epsolay'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). | |||
| US12257348 | Stabilized microcapsules, method of their preparation and uses thereof |
May, 2041
(15 years from now) | Active |
| US12295935 | Method for therapeutic treatment of rosacea |
Dec, 2040
(15 years from now) | Active |
| US11628155 | Method for therapeutic treatment of rosacea |
Dec, 2040
(15 years from now) | Active |
| US11426378 | Method for long-term treatment of rosacea |
Aug, 2040
(14 years from now) | Active |
| US11877997 | Method for providing early onset of action in the treatment of rosacea |
Feb, 2040
(14 years from now) | Active |
| US11541026 | Method for treatment of rosacea |
Feb, 2040
(14 years from now) | Active |
| US10933046 | Method for treatment of rosacea in patients aged 65 years and older |
Feb, 2040
(14 years from now) | Active |
| US11865100 | Method for treatment of rosacea in patients aged 65 years and older |
Feb, 2040
(14 years from now) | Active |
| US10945987 | Method for providing early onset of action in the treatment of rosacea |
Feb, 2040
(14 years from now) | Active |
| US11986456 | Method for treatment of rosacea |
Feb, 2040
(14 years from now) | Active |
| US9687465 | Compositions for the treatment of rosacea |
Nov, 2032
(7 years from now) | Active |
| US9868103 | Metal oxide coating of water insoluble ingredients |
Aug, 2028
(2 years from now) | Active |
| US12350382 | NA |
Feb, 2028
(2 years from now) | Active |
| US12156946 | Method for preparing particles comprising metal oxide coating and particles with metal oxide coating |
Feb, 2028
(2 years from now) | Active |
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 Epsolay's patents.
Latest Legal Activities on Epsolay's Patents
Given below is the list of recent legal activities going on the following patents of Epsolay.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification
Critical | 21 Mar, 2024 | US11541026 |
| Email Notification
Critical | 21 Mar, 2024 | US11426378 |
| Email Notification
Critical | 21 Mar, 2024 | US11628155 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 21 Mar, 2024 | US11426378 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 21 Mar, 2024 | US11541026 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 21 Mar, 2024 | US11628155 |
| Patent eCofC Notification | 20 Feb, 2024 | US11865100 |
| Email Notification
Critical | 20 Feb, 2024 | US11865100 |
| Mail Patent eCofC Notification | 20 Feb, 2024 | US11865100 |
| Recordation of Patent eCertificate of Correction | 20 Feb, 2024 | US11865100 |
FDA has granted several exclusivities to Epsolay. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Epsolay, 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
Epsolay.
Exclusivity Information
Epsolay holds 1 exclusivities. All of its exclusivities have expired in 2025. Details of Epsolay's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 22, 2025 |
US patents provide insights into the exclusivity only within the United States, but
Epsolay 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 Epsolay's family patents as well as insights into
ongoing legal events
on those patents.
Epsolay's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Epsolay's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 23, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epsolay Generics:
There are no approved generic versions for Epsolay as of now.
Alternative Brands for Epsolay
Epsolay which is used for treating inflammatory lesions of rosacea in adults., has several other brand drugs using the same active ingredient (Benzoyl Peroxide). 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 | |||
|---|---|---|---|---|
| Bausch |
| |||
| Galderma Labs |
| |||
| Galderma Labs Lp |
| |||
| Mayne Pharma |
| |||
| Stiefel |
|
About Epsolay
Epsolay is a drug owned by Mayne Pharma Llc. It is used for treating inflammatory lesions of rosacea in adults. Epsolay uses Benzoyl Peroxide as an active ingredient. Epsolay was launched by Mayne Pharma in 2022.
Approval Date:
Epsolay was approved by FDA for market use on 22 April, 2022.
Active Ingredient:
Epsolay uses Benzoyl Peroxide as the active ingredient. Check out other Drugs and Companies using Benzoyl Peroxide ingredient
Treatment:
Epsolay is used for treating inflammatory lesions of rosacea in adults.
Dosage:
Epsolay is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% | CREAM | Prescription | TOPICAL |