EPIDUO Drug Patent Profile
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Which patents cover Epiduo, and when can generic versions of Epiduo launch?
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.
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Questions you can ask:
- What is the 5 year forecast for EPIDUO?
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- What is Average Wholesale Price for EPIDUO?
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: | 22 |
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 |
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.
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 | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 7,964,202 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 8,071,644 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 8,080,537 | ⤷ Subscribe | ⤷ Subscribe | |||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 8,129,362 | ⤷ Subscribe | ⤷ Subscribe | |||
>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
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 | RE34440 | ⤷ Subscribe |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 4,717,720 | ⤷ Subscribe |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 8,936,800 | ⤷ Subscribe |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 8,809,305 | ⤷ Subscribe |
>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
Patent: COMBINACION DE PEROXIDO DE ADAPALENO Y BENZOILO PARA EL TRATAMIENTO DE LESIONES DE ACNE
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 07274288
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0713182
Patent: usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 56456
Patent: ADAPALENE ET PEROXYDE DE BENZOYLE COMBINES UTILISES DANS LE TRAITEMENT DE LESIONS DUES A L'ACNE (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Estimated Expiration: ⤷ Subscribe
China
Patent: 1541320
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 50136
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAR LESIONES DE ACNE
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 14473
Estimated Expiration: ⤷ Subscribe
Patent: 21398
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 46318
Estimated Expiration: ⤷ Subscribe
Patent: 50035
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 46318
Patent: Combinaison d'adapalène et de peroxyde de benzoyle pour le traitement de lésions inflammatoires de l'acné (Combination of adapalene and benzoyl peroxide for treating inflammatory acne lesions)
Estimated Expiration: ⤷ Subscribe
Patent: 50035
Patent: Combinaison d'adapalène et de péroxyde de benzoyle dans le traitement des lésions acnéiques (Combination of adapalene and benzoyl peroxide for treating acne lesions)
Estimated Expiration: ⤷ Subscribe
France
Patent: 03603
Patent: 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)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 43502
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 09542779
Estimated Expiration: ⤷ Subscribe
Patent: 14040481
Patent: COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Subscribe
Patent: 16029094
Patent: 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)
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 50035
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 09000319
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE LESIONES DEL ACNE. (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS.)
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 46318
Estimated Expiration: ⤷ Subscribe
Patent: 50035
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 46318
Estimated Expiration: ⤷ Subscribe
Patent: 50035
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 09104949
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Subscribe
Patent: 12136952
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Subscribe
Patent: 12144414
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 46318
Estimated Expiration: ⤷ Subscribe
Patent: 50035
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 090028764
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Subscribe
Patent: 150003917
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Subscribe
Patent: 160120352
Patent: 여드름 병변 치료를 위한 아다팔렌 및 벤조일 퍼옥시드의 조합물 (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 23951
Estimated Expiration: ⤷ Subscribe
Patent: 03505
Estimated Expiration: ⤷ Subscribe
Turkey
Patent: 1819658
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Australia | 2002364437 | ⤷ Subscribe | |
Japan | 2009542779 | ⤷ Subscribe | |
Australia | 2008246274 | ⤷ Subscribe | |
Canada | 2677167 | UTILISATION D'ADAPALENE ET DE PEROXYDE DE BENZOYLE DANS LE TRAITEMENT A LONG TERME DE L'ACNE VULGAIRE (USE OF ADAPALENE AND BENZOYL PEROXIDE FOR THE LONG TERM TREATMENT OF ACNE VULGARIS) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPIDUO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | 132008901685368 | Italy | ⤷ Subscribe | PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618 |
1458369 | C01458369/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 |
1458369 | SZ 31/2008 | Austria | ⤷ Subscribe | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID |
1458369 | 08C0024 | France | ⤷ Subscribe | 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 |
EPIDUO Market Analysis and Financial Projection Experimental
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