EPIDUO FORTE Drug Patent Profile
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Which patents cover Epiduo Forte, and what generic alternatives are available?
Epiduo Forte is a drug marketed by Galderma Labs and is included in one NDA.
The generic ingredient in EPIDUO FORTE 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 Forte
A generic version of EPIDUO FORTE was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23rd, 2018.
Summary for EPIDUO FORTE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
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 FORTE |
Drug Sales Revenues: | Drug sales revenues for EPIDUO FORTE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPIDUO FORTE |
What excipients (inactive ingredients) are in EPIDUO FORTE? | EPIDUO FORTE excipients list |
DailyMed Link: | EPIDUO FORTE at DailyMed |
Recent Clinical Trials for EPIDUO FORTE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bausch Health Americas, Inc. | Phase 2 |
Beiersdorf | Phase 2 |
Mahidol University | Phase 2 |
Pharmacology for EPIDUO FORTE
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for EPIDUO FORTE
Paragraph IV (Patent) Challenges for EPIDUO FORTE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EPIDUO FORTE | Gel | adapalene; benzoyl peroxide | 0.3%/2.5% | 207917 | 1 | 2016-05-04 |
US Patents and Regulatory Information for EPIDUO FORTE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | 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 |
Expired US Patents for EPIDUO FORTE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPIDUO FORTE
When does loss-of-exclusivity occur for EPIDUO FORTE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1989
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07274288
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0713182
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 56456
Estimated Expiration: ⤷ Sign Up
China
Patent: 1541320
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 50136
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 14473
Estimated Expiration: ⤷ Sign Up
Patent: 21398
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 46318
Estimated Expiration: ⤷ Sign Up
Patent: 50035
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 46318
Estimated Expiration: ⤷ Sign Up
Patent: 50035
Estimated Expiration: ⤷ Sign Up
France
Patent: 03603
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 43502
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09542779
Estimated Expiration: ⤷ Sign Up
Patent: 14040481
Estimated Expiration: ⤷ Sign Up
Patent: 16029094
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 50035
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09000319
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 46318
Estimated Expiration: ⤷ Sign Up
Patent: 50035
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 46318
Estimated Expiration: ⤷ Sign Up
Patent: 50035
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 09104949
Estimated Expiration: ⤷ Sign Up
Patent: 12136952
Estimated Expiration: ⤷ Sign Up
Patent: 12144414
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 46318
Estimated Expiration: ⤷ Sign Up
Patent: 50035
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090028764
Estimated Expiration: ⤷ Sign Up
Patent: 150003917
Estimated Expiration: ⤷ Sign Up
Patent: 160120352
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 23951
Estimated Expiration: ⤷ Sign Up
Patent: 03505
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1819658
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 EPIDUO FORTE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200403759 | GEL COMPRISING AT LEAST A RETINOID AND BENZOYL PEROXIDE | ⤷ Sign Up |
Japan | 2016029094 | 座瘡病変の治療のためのアダパレンと過酸化ベンゾイルとの組合せ (COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS) | ⤷ Sign Up |
Germany | 60327745 | ⤷ Sign Up | |
Poland | 2114392 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPIDUO FORTE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | 122008000041 | Germany | ⤷ Sign Up | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
1458369 | SPC/GB10/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
1458369 | CA 2008 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
1458369 | SZ 31/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |