Epiduo is a drug owned by Galderma Laboratories Lp. It is protected by 10 US drug patents filed from 2013 to 2015. Out of these, 5 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2027. Details of Epiduo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8080537 | Combinations of adapalene and benzoyl peroxide for treating acne lesions |
Jul, 2027
(2 years from now) | Active |
| US8071644 | Combinations of adapalene and benzoyl peroxide for treating acne lesions |
Jul, 2027
(2 years from now) | Active |
| US8129362 | Combination/association of adapalene and benzoyl peroxide for treating acne lesions |
Jul, 2027
(2 years from now) | Active |
| US8445543 | Combinations of adapalene and benzoyl peroxide for treating acne lesions |
Jul, 2027
(2 years from now) | Active |
| US7820186 | Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt |
Nov, 2025
(1 year, 7 days from now) | Active |
| US7964202 | Method for treatment of common acne |
Sep, 2024
(2 months ago) |
Expired
|
| US8809305 | Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US8241649 | Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US8936800 | Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US8105618 | Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Epiduo's patents.
Latest Legal Activities on Epiduo's Patents
Given below is the list of recent legal activities going on the following patents of Epiduo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Apr, 2024 | US8241649 |
| Expire Patent Critical | 04 Mar, 2024 | US8105618 |
| Maintenance Fee Reminder Mailed Critical | 18 Sep, 2023 | US8105618 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Aug, 2023 | US8129362 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2023 | US8080537 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 May, 2023 | US8071644 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Dec, 2022 | US7964202 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Apr, 2022 | US7820186 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Feb, 2022 | US8809305 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8445543 |
FDA has granted several exclusivities to Epiduo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Epiduo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Epiduo.
Exclusivity Information
Epiduo holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Epiduo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Dec 08, 2011 |
| New Patient Population(NPP) | Feb 01, 2016 |
Several oppositions have been filed on Epiduo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Epiduo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Epiduo patents.
Epiduo's Oppositions Filed in EPO
Epiduo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 05, 2014, by Generics [Uk] Limited. This opposition was filed on patent number EP07787478A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08708470A | Mar, 2016 | Generics (U.K.) Limited | Revoked |
| EP07787478A | Mar, 2014 | Generics [UK] Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Epiduo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Epiduo's family patents as well as insights into ongoing legal events on those patents.
Epiduo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Epiduo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epiduo Generic API suppliers:
Adapalene; Benzoyl Peroxide is the generic name for the brand Epiduo. 8 different companies have already filed for the generic of Epiduo, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epiduo's generic
How can I launch a generic of Epiduo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epiduo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epiduo's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Epiduo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1%/2.5% | 30 Dec, 2011 | 1 | 30 Sep, 2015 | 18 Jul, 2027 | Eligible |
Alternative Brands for Epiduo
Epiduo which is used for treating acne., has several other brand drugs in the same treatment category and using the same active ingredient (Adapalene; Benzoyl Peroxide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Bausch |
| |||
| Galderma Labs |
| |||
| Galderma Labs Lp |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Adapalene; Benzoyl Peroxide. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Adapalene; Benzoyl Peroxide, Epiduo's active ingredient. Check the complete list of approved generic manufacturers for Epiduo
About Epiduo
Epiduo is a drug owned by Galderma Laboratories Lp. It is used for treating acne. Epiduo uses Adapalene; Benzoyl Peroxide as an active ingredient. Epiduo was launched by Galderma Labs Lp in 2008.
Approval Date:
Epiduo was approved by FDA for market use on 08 December, 2008.
Active Ingredient:
Epiduo uses Adapalene; Benzoyl Peroxide as the active ingredient. Check out other Drugs and Companies using Adapalene; Benzoyl Peroxide ingredient
Treatment:
Epiduo is used for treating acne.
Dosage:
Epiduo is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1%;2.5% | GEL | Prescription | TOPICAL |