EPSOLAY Drug Patent Profile
✉ Email this page to a colleague
When do Epsolay patents expire, and what generic alternatives are available?
Epsolay is a drug marketed by Galderma Labs Lp and is included in one NDA. There are nine patents protecting this drug.
This drug has twenty-eight patent family members in eleven countries.
The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide profile page.
DrugPatentWatch® Generic Entry Outlook for Epsolay
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 8, 2028. This may change due to patent challenges or generic licensing.
There are two tentative approvals for the generic drug (benzoyl peroxide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for EPSOLAY
International Patents: | 28 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Patent Applications: | 3,533 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EPSOLAY |
What excipients (inactive ingredients) are in EPSOLAY? | EPSOLAY excipients list |
DailyMed Link: | EPSOLAY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EPSOLAY
Generic Entry Date for EPSOLAY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Anatomical Therapeutic Chemical (ATC) Classes for EPSOLAY
US Patents and Regulatory Information for EPSOLAY
EPSOLAY is protected by nine US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPSOLAY is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting EPSOLAY
Method for treatment of rosacea in patients aged 65 years and older
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER
Method for providing early onset of action in the treatment of rosacea
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
Compositions for the treatment of rosacea
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
Metal oxide coating of water insoluble ingredients
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
FDA Regulatory Exclusivity protecting EPSOLAY
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for EPSOLAY
When does loss-of-exclusivity occur for EPSOLAY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06274541
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0614143
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 17681
Estimated Expiration: ⤷ Sign Up
China
Patent: 1277757
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 5815
Estimated Expiration: ⤷ Sign Up
Patent: 0800512
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19606
Estimated Expiration: ⤷ Sign Up
Patent: 31088
Estimated Expiration: ⤷ Sign Up
Patent: 31089
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9159
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 64840
Estimated Expiration: ⤷ Sign Up
Patent: 09503056
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0801146
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1158162
Estimated Expiration: ⤷ Sign Up
Patent: 080039927
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering EPSOLAY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2020170030 | ⤷ Sign Up | |
Canada | 3130439 | METHODE DE TRAITEMENT DE LA ROSACEE CHEZ DES PATIENTS AGES DE 65 ANS ET PLUS (METHOD FOR TREATMENT OF ROSACEA IN PATIENTS AGED 65 YEARS AND OLDER) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2007015243 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPSOLAY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0137963 | 97C0042 | Belgium | ⤷ Sign Up | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
1458369 | C01458369/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 |
1458369 | CA 2008 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |