Epsolay Patent Expiration

Epsolay is a drug owned by Galderma Laboratories Lp. It is protected by 10 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 27, 2040. 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).
US11628155 Method for therapeutic treatment of rosacea
Dec, 2040

(16 years from now)

Active
US11426378 Method for long-term treatment of rosacea
Aug, 2040

(15 years from now)

Active
US10933046 Method for treatment of rosacea in patients aged 65 years and older
Feb, 2040

(15 years from now)

Active
US11865100 Method for treatment of rosacea in patients aged 65 years and older
Feb, 2040

(15 years from now)

Active
US10945987 Method for providing early onset of action in the treatment of rosacea
Feb, 2040

(15 years from now)

Active
US11986456 Method for treatment of rosacea
Feb, 2040

(15 years from now)

Active
US11541026 Method for treatment of rosacea
Feb, 2040

(15 years from now)

Active
US11877997 Method for providing early onset of action in the treatment of rosacea
Feb, 2040

(15 years from now)

Active
US9687465 Compositions for the treatment of rosacea
Nov, 2032

(8 years from now)

Active
US9868103 Metal oxide coating of water insoluble ingredients
Aug, 2028

(3 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.

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

Activity Date Patent Number
Patent litigations
Email Notification 21 Mar, 2024 US11541026
Email Notification 21 Mar, 2024 US11426378
Email Notification 21 Mar, 2024 US11628155
Change in Power of Attorney (May Include Associate POA) 21 Mar, 2024 US11426378
Change in Power of Attorney (May Include Associate POA) 21 Mar, 2024 US11541026
Change in Power of Attorney (May Include Associate POA) 21 Mar, 2024 US11628155
Patent eCofC Notification 20 Feb, 2024 US11865100
Email Notification 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 out of which none have expired. Its last outstanding exclusivity is set to expire 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

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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

Epsolay has patent protection in a total of 12 countries. It has a significant patent presence in the US with 55.6% of its patents being US patents. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Epsolay.

Family Patents

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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 Dec 27, 2040 (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
Acanya
Cabtreo
Onexton
Galderma Labs
Epiduo Forte
Galderma Labs Lp
Epiduo
Twyneo
Stiefel
Duac






About Epsolay

Epsolay is a drug owned by Galderma Laboratories Lp. It is used for treating inflammatory lesions of rosacea in adults. Epsolay uses Benzoyl Peroxide as an active ingredient. Epsolay was launched by Galderma Labs Lp 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