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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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.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method for treatment of common acne
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE
Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE
Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE
Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Australia
Patent: 07274288
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0713182
Patent: usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
China
Patent: 1541320
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 50136
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAR LESIONES DE ACNE
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
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Hungary
Patent: 43502
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09542779
Estimated Expiration: ⤷ Sign Up
Patent: 14040481
Patent: COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Lithuania
Patent: 50035
Estimated Expiration: ⤷ Sign Up
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: ⤷ 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
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Sign Up
Patent: 12136952
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Sign Up
Patent: 12144414
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 46318
Estimated Expiration: ⤷ Sign Up
Patent: 50035
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090028764
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Sign Up
Patent: 150003917
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Sign Up
Patent: 160120352
Patent: 여드름 병변 치료를 위한 아다팔렌 및 벤조일 퍼옥시드의 조합물 (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
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 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2007274288 | Combination of adapalene and benzoyl peroxide for treating acne lesions | ⤷ Sign Up |
| Slovenia | 1458369 | ⤷ Sign Up | |
| Spain | 2546029 | ⤷ Sign Up | |
| Hungary | E043502 | ⤷ Sign Up | |
| China | 101541320 | Combination of adapalene and benzoyl peroxide for treating acne lesions | ⤷ Sign Up |
| European Patent Office | 0199636 | BENZONAPHTHALENIC DERIVATIVES, PROCESS FOR THEIR PREPARATION AND THEIR USE IN PHARMACY AND COSMETICS | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618 |
| 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 | CA 2008 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
| 1458369 | 380 | Finland | ⤷ Sign Up | |
| 1458369 | SZ 31/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID |
| 1458369 | 08C0024 | France | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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