EPIDUO Drug Patent Profile
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When do Epiduo patents expire, and what generic alternatives are available?
Epiduo is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-eight patent family members in twenty-five countries.
The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epiduo
A generic version of EPIDUO was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23rd, 2018.
Summary for EPIDUO
International Patents: | 68 |
US Patents: | 5 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 31 |
Patent Applications: | 26 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EPIDUO |
Drug Sales Revenues: | Drug sales revenues for EPIDUO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPIDUO |
What excipients (inactive ingredients) are in EPIDUO? | EPIDUO excipients list |
DailyMed Link: | EPIDUO at DailyMed |
Recent Clinical Trials for EPIDUO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bausch Health Americas, Inc. | Phase 2 |
Mahidol University | Phase 2 |
Beiersdorf | Phase 2 |
Pharmacology for EPIDUO
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for EPIDUO
Paragraph IV (Patent) Challenges for EPIDUO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EPIDUO | Gel | adapalene; benzoyl peroxide | 0.1%/2.5% | 022320 | 1 | 2011-12-30 |
US Patents and Regulatory Information for EPIDUO
EPIDUO is protected by five US patents.
Patents protecting EPIDUO
Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for treatment of common acne
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Expired US Patents for EPIDUO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPIDUO
When does loss-of-exclusivity occur for EPIDUO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1989
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07274288
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0713182
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 56456
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1541320
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 50136
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 14473
Estimated Expiration: ⤷ Try a Trial
Patent: 21398
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 46318
Estimated Expiration: ⤷ Try a Trial
Patent: 50035
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 46318
Estimated Expiration: ⤷ Try a Trial
Patent: 50035
Estimated Expiration: ⤷ Try a Trial
France
Patent: 03603
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 43502
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09542779
Estimated Expiration: ⤷ Try a Trial
Patent: 14040481
Estimated Expiration: ⤷ Try a Trial
Patent: 16029094
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 50035
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09000319
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 46318
Estimated Expiration: ⤷ Try a Trial
Patent: 50035
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 46318
Estimated Expiration: ⤷ Try a Trial
Patent: 50035
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 09104949
Estimated Expiration: ⤷ Try a Trial
Patent: 12136952
Estimated Expiration: ⤷ Try a Trial
Patent: 12144414
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 46318
Estimated Expiration: ⤷ Try a Trial
Patent: 50035
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 090028764
Estimated Expiration: ⤷ Try a Trial
Patent: 150003917
Estimated Expiration: ⤷ Try a Trial
Patent: 160120352
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 23951
Estimated Expiration: ⤷ Try a Trial
Patent: 03505
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1819658
Estimated Expiration: ⤷ Try a Trial
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 EPIDUO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 10199023 | ⤷ Try a Trial | |
Norway | 170627 | ⤷ Try a Trial | |
Australia | 2008246274 | ⤷ Try a Trial | |
Norway | 861413 | ⤷ Try a Trial | |
Russian Federation | 2481832 | ПРИМЕНЕНИЕ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ПРОДОЛЖИТЕЛЬНОГО ЛЕЧЕНИЯ УГРЕЙ ОБЫКНОВЕННЫХ (APPLICATION OF ADAPALENE AND BENZOYL PEROXIDE FOR LONG-TERM TREATMENT OF ACNE VULGARIS) | ⤷ Try a Trial |
France | 2903603 | COMBINAISON D'ADAPALENE ET DE PEROXYDE DE BENZOLE DANS LE TRAITEMENT DE L'ACNE (Use of adapalene for the preparation of composition to be administered in combination/in association with benzoyl peroxide for reducing the number of acne injuries such as inflammatory and/or non-inflammatory type) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPIDUO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | SZ 31/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID |
1458369 | 380 | Finland | ⤷ Try a Trial | |
1458369 | SPC/GB10/005 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
1458369 | CA 2008 00029 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
1458369 | C01458369/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 |
1458369 | 08C0024 | France | ⤷ Try a Trial | PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |