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: ⤷ 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 | |||
| >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 |
| >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: ⤷ 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 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 2046318 | ⤷ Sign Up | |
| Luxembourg | 85849 | ⤷ Sign Up | |
| Norway | 861413 | ⤷ 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 | SPC/GB10/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
| 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 | SZ 31/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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